Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT00313820
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2006-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of \\< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.', 'otherNumAtRisk': 110, 'otherNumAffected': 59, 'seriousNumAtRisk': 110, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.', 'otherNumAtRisk': 109, 'otherNumAffected': 25, 'seriousNumAtRisk': 109, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.578', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'groupDescription': 'Modelled Results: Endpoint Mean Pain Score Pregabalin vs Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'ANCOVA with treatment and country as factors and baseline pain score as covariate.'}, {'pValue': '0.294', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Interaction p-value based on adding interaction term to the main model.', 'groupDescription': 'Modelled Results: Treatment by country interaction', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to Week 12', 'description': 'Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT): received at least 1 dose study medication and completed at least 1 post-baseline assessment. Endpoint = Week 12 or ET'}, {'type': 'SECONDARY', 'title': 'Pain Score as Measured by DPRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'title': 'Week 1 (n=108, 108)', 'categories': [{'measurements': [{'value': '5.6', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=104, 106)', 'categories': [{'measurements': [{'value': '5.3', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=102, 105)', 'categories': [{'measurements': [{'value': '5.1', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=97, 102)', 'categories': [{'measurements': [{'value': '4.9', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=98, 97)', 'categories': [{'measurements': [{'value': '4.8', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 [ET] (n=92, 92)', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.161', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.1', 'pValueComment': 'Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 1 Modelled Results', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.062', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.0', 'pValueComment': 'Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 2 Modelled Results', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.1', 'pValueComment': 'Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 3 Modelled Results', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.1', 'pValueComment': 'Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 6 Modelled Results', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.105', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.1', 'pValueComment': 'Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 9 Modelled Results', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.592', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.4', 'pValueComment': 'Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 12 Modelled Results', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12', 'description': 'Weekly mean pain score measured by DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; (n) = number of participants with analyzable data at observation for pregabalin and placebo, respectively; weeks as specified in timeframe through Week 12 \\[ET\\]'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'title': '30% Responders Yes', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': '30% Responders No', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.087', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.', 'groupDescription': '30% Responders', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': '30% Responder Yes = number of subjects with 30% reduction in mean pain score from baseline to observation; 30% reduction calculated as \\[(T minus B) divided by B multiplied by 100\\] \\< = negative 30. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 30% Responder No indicates number of subjects that did not reach 30% reduction in mean pain score.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; endpoint = Week 12 or ET'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'title': '50 % Responders Yes', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': '50 % Responders No', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.622', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.', 'groupDescription': '50% Responders', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': '50% Responder Yes = number of subjects with 50% reduction in mean pain score from baseline to observation; 50% reduction calculated as \\[(T minus B) divided by B multiplied by 100\\] \\< = negative 50. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 50% Responder No indicates number of subjects that did not reach 50% reduction in mean pain score.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; endpoint = Week 12 or ET'}, {'type': 'SECONDARY', 'title': 'Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'title': 'Week 1 (n=108, 108)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=104, 106)', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=102, 105)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=98, 102)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (n=98, 97)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=92, 92)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint [Week 12 or ET] (n=108, 108)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.1', 'pValueComment': 'Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 1; Modelled Results', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.0', 'pValueComment': 'Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 2; Modelled Results', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.2', 'pValueComment': 'Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 3; Modelled Results', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.2', 'pValueComment': 'Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 6; Modelled Results', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.078', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.0', 'pValueComment': 'Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 9; Modelled Results', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.663', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.4', 'pValueComment': 'Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 12; Modelled Results', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.4', 'pValueComment': 'Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Endpoint \\[Week 12 or ET\\]; Modelled Results', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12', 'description': 'DSIS: subject rated 11-point numeric scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. Endpoint calculated as mean of last 7 available scores.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; endpoint = Week 12 or ET.'}, {'type': 'SECONDARY', 'title': 'Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '49.5', 'spread': '2.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.741', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '5.0', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline value as a covariate', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.05', 'groupDescription': 'Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'SF-MPQ Part B VAS consists of a line 0 to 100 millimeters (mm) in length; range is (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Neuropathic Pain Symptom Inventory (NPSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'title': 'Burning Pain (n=108, 108)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Pressing Pain (n=108, 107)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Paroxysmal Pain (n=108, 108)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Evoked Pain (n=108, 108)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'P/D (n=108, 108)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Total Score (n=108, 107)', 'categories': [{'measurements': [{'value': '25.7', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '28.5', 'spread': '1.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.216', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.2', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'Burning Pain Week 12 \\[LOCF\\]; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.760', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.6', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Pressing Pain Week 12 \\[LOCF\\]; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.360', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.3', 'pValueComment': 'Estimated from ANCOVA (general linear model) general linear model with treatment and country as factors and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Paroxysmal Pain Week 12 \\[LOCF\\]; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.239', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.2', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Evoked Pain Week 12 \\[LOCF\\]; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.118', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.1', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'P/D Week 12 \\[LOCF\\]; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.138', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '0.9', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.87', 'groupDescription': 'Total Score Week 12 \\[LOCF\\]; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'NPSI: subject rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \\[superficial\\] spontaneous pain, pressing \\[deep\\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \\[P/D\\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score (0 to 100). Higher score indicates a greater intensity of pain.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; (N) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12/Last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Medical Outcome Study (MOS) Sleep Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'title': 'Sleep disturbance (n=100, 97)', 'categories': [{'measurements': [{'value': '27.1', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '31.9', 'spread': '2.05', 'groupId': 'OG001'}]}]}, {'title': 'Snoring score (n=98, 97)', 'categories': [{'measurements': [{'value': '40.6', 'spread': '2.68', 'groupId': 'OG000'}, {'value': '32.9', 'spread': '2.75', 'groupId': 'OG001'}]}]}, {'title': 'Awaken SOB or headache (n=99, 97)', 'categories': [{'measurements': [{'value': '11.3', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Sleep quantity (100, 97)', 'categories': [{'measurements': [{'value': '7.0', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Sleep adequacy (n=99, 97)', 'categories': [{'measurements': [{'value': '67.5', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '58.9', 'spread': '2.51', 'groupId': 'OG001'}]}]}, {'title': 'Somnolence (n=99, 97)', 'categories': [{'measurements': [{'value': '39.9', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '1.84', 'groupId': 'OG001'}]}]}, {'title': 'Overall sleep problems index (n=100, 97)', 'categories': [{'measurements': [{'value': '28.2', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '32.4', 'spread': '1.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.086', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-4.8', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '0.7', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.79', 'groupDescription': 'Sleep disturbance; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '7.7', 'ciLowerLimit': '0.4', 'ciUpperLimit': '15.1', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.72', 'groupDescription': 'Snoring score; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.169', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-3.7', 'ciLowerLimit': '-9.1', 'ciUpperLimit': '1.6', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.71', 'groupDescription': 'Awaken SOB or headache; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.7', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'groupDescription': 'Sleep quantity; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '8.6', 'ciLowerLimit': '1.8', 'ciUpperLimit': '15.4', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.44', 'groupDescription': 'Sleep adequacy; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.399', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '7.1', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.51', 'groupDescription': 'Somnolence; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '-0.0', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.13', 'groupDescription': 'Overall sleep problems index; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'MOS: subject rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'title': 'Optimal sleep = Yes', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Optimal sleep = No', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.201', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '0.8', 'ciUpperLimit': '2.9', 'pValueComment': 'Estimated from a logistic regression model with treatment and the baseline assessment as factors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'estimateComment': 'Standard error of the mean = standard error of the odds ratio.', 'groupDescription': 'Modelled Results', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of subjects with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is \\< 7 hours per night.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety and Depression Scale (HADS) - ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'title': 'Week 12 [LOCF] Anxiety score', 'categories': [{'measurements': [{'value': '5.5', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 [LOCF] Depression score', 'categories': [{'measurements': [{'value': '6.7', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '-0.2', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.40', 'groupDescription': 'Week 12 \\[LOCF\\] Anxiety score; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.600', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.0', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'groupDescription': 'Week 12 \\[LOCF\\] Depression score; Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'HADS is subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Week 12 \\[LOCF\\]'}, {'type': 'SECONDARY', 'title': 'Euro Quality of Life (EQ-5D)- Health State Profile Utility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.566', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.1', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'groupDescription': 'Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'EQ-5D - VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '62.7', 'spread': '1.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.220', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '7.9', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and coutntry as factors and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.47', 'groupDescription': 'Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.144', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.1', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treament and country as factors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': "PGIC: subject rated instrument to measure subject's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).", 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression of Change (CGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '-0.0', 'pValueComment': 'Estimated from ANCOVA (general linear model) with treatment and country as factors.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Modelled Results', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': "CGIC: clinician rated instrument that measures change in a subject's ovall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).", 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'QANeP: assessment of sensory threshold: subject responds "yes" when monofilament stimulus is felt on area of maximum pain: 1 (lowest/softest 0.07 gram \\[g\\]) to 6 (highest 300 g) or 7 (not perceived); rated by lowest/softest filament felt when in contact with the skin. Summarized as change from baseline (mean at observation minus mean at baseline).', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Week 12 \\[LOCF\\].'}, {'type': 'SECONDARY', 'title': 'QANeP - Pain Rating Scales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'classes': [{'title': 'SMA (n=108, 107)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.93', 'groupId': 'OG001'}]}]}, {'title': 'DMA (n=108, 107)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.83', 'groupId': 'OG001'}]}]}, {'title': 'PH reference area (n=108, 107)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.41', 'groupId': 'OG001'}]}]}, {'title': 'PH test area (n=108, 107)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '2.37', 'groupId': 'OG001'}]}]}, {'title': 'TSTS (n=108, 106)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'CA (n=108, 106)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'CH reference area (n=107, 107)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': 'CH test area (n=107, 106)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Subject rated pain scale: static mechanical allodynia (SMA) gentle constant mechanical pressure; dynamic mechanical allodynia (DMA) gentle stroking with foam brush; punctate hyperalgesia (PH) pinprick; cold allodynia (CA) touch with cool metal rod 13-17° celsius (C); cold hyperalgesia (CH) touch with cold metal rod 4° C; temporal summation to tactile stimuli (TSTS) repeated touching/tapping. 11-point numeric scale; range 0 (no pain) to 10 (worst possible pain). Reference area=mirror image of pain site (test area). Summarized as change from baseline (mean at observation minus mean at baseline).', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; (n) = number of subjects with analyzable data at observation for pregabalin and placebo, respectively; Week 12 \\[LOCF\\].'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'FG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}], 'periods': [{'title': 'Assigned to Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Pregabalin or Placebo Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Two-week screening and washout phase prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pregabalin', 'description': '75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'BG001', 'title': 'Placebo', 'description': '75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '57.1', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-21', 'studyFirstSubmitDate': '2006-04-10', 'resultsFirstSubmitDate': '2009-09-08', 'studyFirstSubmitQcDate': '2006-04-11', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-09-08', 'studyFirstPostDateStruct': {'date': '2006-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)', 'timeFrame': 'Up to Week 12', 'description': 'Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.'}], 'secondaryOutcomes': [{'measure': 'Pain Score as Measured by DPRS', 'timeFrame': 'Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12', 'description': 'Weekly mean pain score measured by DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication.'}, {'measure': 'Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint', 'timeFrame': 'Baseline, Week 12', 'description': '30% Responder Yes = number of subjects with 30% reduction in mean pain score from baseline to observation; 30% reduction calculated as \\[(T minus B) divided by B multiplied by 100\\] \\< = negative 30. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 30% Responder No indicates number of subjects that did not reach 30% reduction in mean pain score.'}, {'measure': 'Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint', 'timeFrame': 'Baseline, Week 12', 'description': '50% Responder Yes = number of subjects with 50% reduction in mean pain score from baseline to observation; 50% reduction calculated as \\[(T minus B) divided by B multiplied by 100\\] \\< = negative 50. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 50% Responder No indicates number of subjects that did not reach 50% reduction in mean pain score.'}, {'measure': 'Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])', 'timeFrame': 'Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12', 'description': 'DSIS: subject rated 11-point numeric scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. Endpoint calculated as mean of last 7 available scores.'}, {'measure': 'Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only', 'timeFrame': 'Week 12', 'description': 'SF-MPQ Part B VAS consists of a line 0 to 100 millimeters (mm) in length; range is (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.'}, {'measure': 'Neuropathic Pain Symptom Inventory (NPSI)', 'timeFrame': 'Week 12', 'description': 'NPSI: subject rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \\[superficial\\] spontaneous pain, pressing \\[deep\\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \\[P/D\\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score (0 to 100). Higher score indicates a greater intensity of pain.'}, {'measure': 'Medical Outcome Study (MOS) Sleep Scale', 'timeFrame': 'Week 12', 'description': 'MOS: subject rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.'}, {'measure': 'Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep', 'timeFrame': 'Week 12', 'description': 'MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of subjects with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is \\< 7 hours per night.'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS) - ITT Population', 'timeFrame': 'Week 12', 'description': 'HADS is subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.'}, {'measure': 'Euro Quality of Life (EQ-5D)- Health State Profile Utility Score', 'timeFrame': 'Week 12', 'description': 'EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.'}, {'measure': 'EQ-5D - VAS', 'timeFrame': 'Week 12', 'description': 'EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.'}, {'measure': 'Patient Global Impression of Change (PGIC)', 'timeFrame': 'Week 12', 'description': "PGIC: subject rated instrument to measure subject's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse)."}, {'measure': 'Clinical Global Impression of Change (CGIC)', 'timeFrame': 'Week 12', 'description': "CGIC: clinician rated instrument that measures change in a subject's ovall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse)."}, {'measure': 'Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold', 'timeFrame': 'Baseline, Week 12', 'description': 'QANeP: assessment of sensory threshold: subject responds "yes" when monofilament stimulus is felt on area of maximum pain: 1 (lowest/softest 0.07 gram \\[g\\]) to 6 (highest 300 g) or 7 (not perceived); rated by lowest/softest filament felt when in contact with the skin. Summarized as change from baseline (mean at observation minus mean at baseline).'}, {'measure': 'QANeP - Pain Rating Scales', 'timeFrame': 'Baseline, Week 12', 'description': 'Subject rated pain scale: static mechanical allodynia (SMA) gentle constant mechanical pressure; dynamic mechanical allodynia (DMA) gentle stroking with foam brush; punctate hyperalgesia (PH) pinprick; cold allodynia (CA) touch with cool metal rod 13-17° celsius (C); cold hyperalgesia (CH) touch with cold metal rod 4° C; temporal summation to tactile stimuli (TSTS) repeated touching/tapping. 11-point numeric scale; range 0 (no pain) to 10 (worst possible pain). Reference area=mirror image of pain site (test area). Summarized as change from baseline (mean at observation minus mean at baseline).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post-stroke pain, pregabalin'], 'conditions': ['Central Neuropathic Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081063&StudyName=Efficacy%20Of%20Pregabalin%20In%20Subjects%20With%20Post-Stroke%20Central%20Neuropathic%20Pain', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive history of clinical stroke at least 4 months prior to randomization CPSP--3 months prior to screening\n\nExclusion Criteria:\n\n* History of dementia or any other severe cognitive impairment\n* Diabetic Peripheral Neuropathy (DPN)'}, 'identificationModule': {'nctId': 'NCT00313820', 'briefTitle': 'Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A 13-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150-600 Mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Central Post-Stroke Pain (CPSP)', 'orgStudyIdInfo': {'id': 'A0081063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin', 'description': 'The change from in pain scores from baseline to endpoint among stroke subjects receiving pregabalin will be compared to change in pain scores from baseline to endpoint among stroke subjects receiving matched placebo.', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The change in pain scores from baseline to endpoint will be compared among the two treatment groups- ie subjects receiving 12 weeks of pregabalin treatment vs subjects receiving 12 weeks of placebo treatment.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'description': 'Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.', 'armGroupLabels': ['Pregabalin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '2250', 'city': 'East Gosford', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.43874, 'lon': 151.35338}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '2502', 'city': 'Warrawong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -34.485, 'lon': 150.88833}}, {'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -27.44453, 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