Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-26 @ 10:28 AM
Study NCT ID:
NCT00609466
Status:
COMPLETED
Last Update Posted:
2011-11-16
First Post:
2008-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical-Trials@grunenthal.com', 'phone': '49 241 569 3223', 'title': 'René Allard', 'organization': 'Grunenthal'}, 'certainAgreement': {'otherDetails': 'Grünenthal GmbH reserves the right to review any publication pertaining to the trial before it is submitted for publication. Neither Grünenthal nor the investigator has the right to prohibit publication unless publication can be shown to affect possible patent rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Lortab (hydrocodone/acetaminophen) was allowed as rescue medication.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CG5503', 'description': 'CG5503 IR 75mg 4-6 hourly', 'otherNumAffected': 69, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Morphine', 'description': 'Morphine IR 30mg 4 to 6 hourly', 'otherNumAffected': 85, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Matching Placebo 4 to 6 hourly', 'otherNumAffected': 47, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 79, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 147, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 34, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 40, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 156, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 62, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 39, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 25, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 27, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 38, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 32, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 29, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gamma glutamyl transferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Stevens Johnson Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CG5503', 'description': 'CG5503 IR 75mg 4-6 hourly'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Morphine IR 30mg 4 to 6 hourly'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo 4 to 6 hourly'}], 'classes': [{'categories': [{'measurements': [{'value': '46.2', 'spread': '130.83', 'groupId': 'OG000'}, {'value': '102.5', 'spread': '153.26', 'groupId': 'OG001'}, {'value': '-17.5', 'spread': '111.27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean', 'ciPctValue': '95', 'paramValue': '70.8', 'ciLowerLimit': '35.9', 'ciUpperLimit': '105.6', 'pValueComment': 'No multiplicity adjustment used.', 'groupDescription': 'Null hypothesis of no treatment difference.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline value to 48 hours after first study drug intake.', 'description': 'Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \\[baseline-post baseline\\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain).', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to Treat - randomized subjects who were dosed and had a baseline pain intensity assessment. Last observation carried forward was used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CG5503', 'description': 'CG5503 IR 75mg 4-6 hourly'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Morphine IR 30mg 4 to 6 hourly'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo 4 to 6 hourly'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Test for time (in hours) to first rescue medication use. No multiplicity adjustment.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for site', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 72 hours after first study drug intake', 'description': 'Number of participants who used at least one dose of rescue medication during the 72 hour double blind period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) and Last Observation Carried Forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief (TOTPAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CG5503', 'description': 'CG5503 IR 75mg 4-6 hourly'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Morphine IR 30mg 4 to 6 hourly'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo 4 to 6 hourly'}], 'classes': [{'categories': [{'measurements': [{'value': '79.2', 'spread': '49.63', 'groupId': 'OG000'}, {'value': '81.6', 'spread': '56.30', 'groupId': 'OG001'}, {'value': '41.8', 'spread': '50.88', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean', 'ciPctValue': '95', 'paramValue': '37.5', 'ciLowerLimit': '22.7', 'ciUpperLimit': '52.2', 'pValueComment': 'No multiplicity adjustment used', 'groupDescription': 'Null hypothesis of no treatment difference.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 48 hours after first study drug intake', 'description': 'Total pain relief (TOTPAR) in the 48 hour period from the first dose of study drug. The subject was to indicate pain relief at rest in response to the following question: How much relief have you had from your starting pain? None = 0, A little = 1, Some = 2, A lot = 3 and Complete = 4. The theoretical maximum range of Total pain relief (TOTPAR)48 is from 0 (indicative of no pain relief) to 192. The higher the value the better the pain relief.', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat(ITT)and Last Observation Carried Forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CG5503', 'description': 'CG5503 IR 75mg 4-6 hourly'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Morphine IR 30mg 4 to 6 hourly'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo 4 to 6 hourly'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '13.51', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '15.59', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '13.10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square means', 'ciPctValue': '95', 'paramValue': '9.9', 'ciLowerLimit': '6.2', 'ciUpperLimit': '13.6', 'pValueComment': 'No multiplicity adjustment used.', 'groupDescription': 'Null hypothesis of no treatment difference.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 hours after intake of first study drug', 'description': 'Pain Intensity assessed at predefined time points over a 6 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \\[baseline-post baseline\\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID6) is from -60 (indicative of an increase in pain) to 60 (indicative of a decrease in pain).', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat(ITT) and Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CG5503', 'description': 'CG5503 IR 75mg 4-6 hourly'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Morphine IR 30mg 4 to 6 hourly'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo 4 to 6 hourly'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '28.89', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '32.12', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '24.82', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean', 'ciPctValue': '95', 'paramValue': '20.6', 'ciLowerLimit': '13.2', 'ciUpperLimit': '28.0', 'pValueComment': 'No multiplicity adjustment used.', 'groupDescription': 'Null hypothesis of no treatment difference.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 hours after first study drug intake', 'description': 'Pain Intensity assessed at predefined time points over a 12 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \\[baseline-post baseline\\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID12) is from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain).', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) and Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CG5503', 'description': 'CG5503 IR 75mg 4-6 hourly'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Morphine IR 30mg 4 to 6 hourly'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo 4 to 6 hourly'}], 'classes': [{'categories': [{'measurements': [{'value': '22.3', 'spread': '60.17', 'groupId': 'OG000'}, {'value': '41.3', 'spread': '68.96', 'groupId': 'OG001'}, {'value': '-10.7', 'spread': '51.28', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean', 'ciPctValue': '95', 'paramValue': '36.4', 'ciLowerLimit': '20.7', 'ciUpperLimit': '52.0', 'pValueComment': 'No multiplicity adjustment used.', 'groupDescription': 'Null hypothesis of no treatment difference.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 hours after first study drug intake', 'description': 'Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \\[baseline-post baseline\\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain).', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT)and Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CG5503', 'description': 'CG5503 IR 75mg 4-6 hourly'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Morphine IR 30mg 4 to 6 hourly'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo 4 to 6 hourly'}], 'classes': [{'categories': [{'measurements': [{'value': '78.4', 'spread': '212.05', 'groupId': 'OG000'}, {'value': '174.1', 'spread': '242', 'groupId': 'OG001'}, {'value': '-19.1', 'spread': '179.48', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square means', 'ciPctValue': '95', 'paramValue': '108.2', 'ciLowerLimit': '51.9', 'ciUpperLimit': '164.5', 'pValueComment': 'No multiplicity adjustment used.', 'groupDescription': 'Null hypothesis of no treatment difference.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 72 hours after first intake of study drug', 'description': 'Pain Intensity assessed at predefined time points over a 72 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \\[baseline-post baseline\\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID72) is from -720 (indicative of an increase in pain) to 720 (indicative of a decrease in pain).', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) and Last Observation Carried Forward (LOCF).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CG5503', 'description': 'CG5503 IR 75mg 4-6 hourly'}, {'id': 'FG001', 'title': 'Morphine', 'description': 'Morphine IR 30mg 4 to 6 hourly'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Matching Placebo 4 to 6 hourly'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The recruitment period for this in-patient, multicenter study occurred between 04 September 2007 and 11 December 2007.', 'preAssignmentDetails': 'The trial consisted of a Screening Period (Day -28 up to the first surgical incision on Day -1), a Surgical Period (Day -1 to Day 1 at approximately 03:00 h.), a Qualification Period (Day 1), a Double-Blind Treatment Period (Day 1 up to Day 4), and a Follow-up Period (Day 8 up to Day 18).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '291', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CG5503', 'description': 'CG5503 IR 75mg 4-6 hourly'}, {'id': 'BG001', 'title': 'Morphine', 'description': 'Morphine IR 30mg 4 to 6 hourly'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Matching Placebo 4 to 6 hourly'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '272', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.6', 'spread': '12.58', 'groupId': 'BG000'}, {'value': '43.7', 'spread': '14.19', 'groupId': 'BG001'}, {'value': '43.8', 'spread': '13.93', 'groupId': 'BG002'}, {'value': '44.0', 'spread': '13.55', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '244', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '291', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-10', 'studyFirstSubmitDate': '2008-01-24', 'resultsFirstSubmitDate': '2009-09-16', 'studyFirstSubmitQcDate': '2008-01-24', 'lastUpdatePostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-22', 'studyFirstPostDateStruct': {'date': '2008-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.', 'timeFrame': 'Baseline value to 48 hours after first study drug intake.', 'description': 'Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \\[baseline-post baseline\\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Using Rescue Medication', 'timeFrame': 'Baseline up to 72 hours after first study drug intake', 'description': 'Number of participants who used at least one dose of rescue medication during the 72 hour double blind period.'}, {'measure': 'Total Pain Relief (TOTPAR)', 'timeFrame': 'Baseline to 48 hours after first study drug intake', 'description': 'Total pain relief (TOTPAR) in the 48 hour period from the first dose of study drug. The subject was to indicate pain relief at rest in response to the following question: How much relief have you had from your starting pain? None = 0, A little = 1, Some = 2, A lot = 3 and Complete = 4. The theoretical maximum range of Total pain relief (TOTPAR)48 is from 0 (indicative of no pain relief) to 192. The higher the value the better the pain relief.'}, {'measure': 'Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity', 'timeFrame': 'Baseline to 6 hours after intake of first study drug', 'description': 'Pain Intensity assessed at predefined time points over a 6 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \\[baseline-post baseline\\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID6) is from -60 (indicative of an increase in pain) to 60 (indicative of a decrease in pain).'}, {'measure': 'Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity', 'timeFrame': 'Baseline to 12 hours after first study drug intake', 'description': 'Pain Intensity assessed at predefined time points over a 12 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \\[baseline-post baseline\\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID12) is from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain).'}, {'measure': 'Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity', 'timeFrame': 'Baseline to 24 hours after first study drug intake', 'description': 'Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \\[baseline-post baseline\\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain).'}, {'measure': 'Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity', 'timeFrame': 'Baseline to 72 hours after first intake of study drug', 'description': 'Pain Intensity assessed at predefined time points over a 72 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \\[baseline-post baseline\\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID72) is from -720 (indicative of an increase in pain) to 720 (indicative of a decrease in pain).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Opioid', 'Central acting analgesic', 'CG5503 IR', 'Postoperative pain', 'Bunionectomy', 'Morphine', 'Placebo'], 'conditions': ['Bunionectomy', 'Pain', 'Postoperative Pain', 'Acute Pain']}, 'descriptionModule': {'briefSummary': 'The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects following bunionectomy.\n\nThis trial was performed based on a previously performed double-blind, placebo-controlled, multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75 and 100 mg) published under PMID: 18851776.', 'detailedDescription': 'Subjects undergoing bunionectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. CG5503, a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this trial is to investigate the effectiveness (level of pain control) and safety (side effects) of CG5503 IR 75mg compared with no drug (placebo) or one dose of morphine (an opioid commonly used to treat post-surgical pain). This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter trial to evaluate the treatment of acute pain after bunionectomy. The trial will include a blinded 72 hour inpatient phase immediately following bunionectomy, during which subjects will be treated with either 75-mg CG5503 IR, a placebo, or 30-mg morphine, and pain relief will be periodically assessed. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR), and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and morphine. The alternative trial hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 48 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects between 18 and 80 years of age;\n* Scheduled to undergo primary unilateral first metatarsal bunionectomy;\n* Anesthesiological and surgical procedures performed according to protocol;\n* Moderate or severe baseline pain following bunionectomy on a VRS within 9 hours of termination of the continuous popliteal sciatic block or systemic analgesia;\n* Pain following bunionectomy of at least 4 on an 11-point NRS within 9 hours of termination of the continuous popliteal sciatic block or systemic analgesia; American Society of Anesthesiologists (ASA) classification I-III.\n\nExclusion Criteria:\n\n* History of seizure disorder;\n* History of alcohol, medication or drug dependency, unstable psychological personality requiring intermittent or permanent treatment; severely impaired renal function, moderately or severely impaired hepatic function;\n* Contraindications to, or history of allergy or hypersensitivity to CG5503, oxycodone, morphine, fentanyl hydrocodone, acetaminophen, heparin, or any compound planned to be used during the anesthesia, or their excipients;\n* Pre-operative use within 12h prior to surgery or peri-operative use of non- steroidal anti-inflammatory drugs (NSAIDs);\n* Treated regularly with opioid analgesic or NSAIDs within 30 days prior to screening;'}, 'identificationModule': {'nctId': 'NCT00609466', 'briefTitle': 'A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Grünenthal GmbH'}, 'officialTitle': 'A Randomized, Double-blind, Parallel-group, Multi-center, Active- and Placebo-controlled Trial to Evaluate the Analgesic Efficacy and Safety of Multiple Doses of CG5503 IR for Postoperative Pain Following Bunionectomy', 'orgStudyIdInfo': {'id': '574139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'CG5503 IR 75mg 4 to 6 hourly for 72 hours', 'interventionNames': ['Drug: CG5503 IR']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Morphine IR 30 mg 4 to 6 hourly for 72 hours', 'interventionNames': ['Drug: Morphine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Matching placebo 4 to 6 hourly for 72 hours', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CG5503 IR', 'type': 'DRUG', 'description': '75mg IR 4 - 6 hourly Total: 72 hours', 'armGroupLabels': ['1']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'Morphine 30 mg IR 4 - 6 hourly Total: 72 hours', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo; 4 - 6 hourly; Total: 72 hours', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21122', 'city': 'Pasadena', 'state': 'Maryland', 'country': 'United States', 'facility': 'Site 104', 'geoPoint': {'lat': 39.119, 'lon': -76.57108}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 101', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77081', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 102', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 105', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78666', 'city': 'San Marcos', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 103', 'geoPoint': {'lat': 29.88327, 'lon': -97.94139}}, {'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Site 106', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Stephen E Daniels, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Premier Research Group (formerly SCIREX Corporation)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grünenthal GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}