Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT00833794
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2009-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1 450 686 1017', 'title': 'Director of Regulatory Affairs', 'organization': 'Labopharm Inc.'}, 'certainAgreement': {'otherDetails': "Prior to submitting results communications, the investigator shall allow Labopharm at least 30 days to review the proposed communication. If the proposed publication/disclosure risks Labopharm's ability to patent any invention related to the study, the publication or disclosure will be modified or delayed to allow Labopharm to seek patent protection. This statement does not give Labopharm any editorial rights other than to restrict the disclosure of Labopharm's confidential information.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1 Tramadol Once A Day', 'otherNumAffected': 136, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': '2 Placebo', 'otherNumAffected': 29, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numEvents': 86, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numEvents': 73, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numEvents': 40, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1023, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1023, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1023, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1023, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Popliteal bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1023, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1023, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1023, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1023, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1023, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1023, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1023, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Tramadol Once A Day'}, {'id': 'OG001', 'title': '2 Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain. The mean score at the end of the study (week 12 or time of discontinuation) was calculated.', 'unitOfMeasure': 'Points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.'}, {'type': 'SECONDARY', 'title': 'Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Tramadol Once A Day'}, {'id': 'OG001', 'title': '2 Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain', 'unitOfMeasure': 'Points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.'}, {'type': 'SECONDARY', 'title': 'Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '325', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 Tramadol Once A Day'}, {'id': 'OG001', 'title': '2 Placebo'}, {'id': 'OG002', 'title': 'Tramadol Once A Day 200 mg'}, {'id': 'OG003', 'title': 'Tramadol Once A Day 300 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '2.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Pain Intensity Score (an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) was stratified by final dose level, at week 12 or time of discontinuation. The final optimum dose level based upon efficacy and tolerability was kept for the entire study. The mean score was calculated.', 'unitOfMeasure': 'Points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.'}, {'type': 'SECONDARY', 'title': 'WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Tramadol Once A Day'}, {'id': 'OG001', 'title': '2 Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Mean WOMAC Pain Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC pain subscale results from the sum of 5 pain questions. The maximum total score is 20.', 'unitOfMeasure': 'Points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.'}, {'type': 'SECONDARY', 'title': 'WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Tramadol Once A Day'}, {'id': 'OG001', 'title': '2 Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '24.9', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '27.5', 'spread': '13.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Mean WOMAC Physical Function Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC Physical Function subscale results from the sum of 17 physical function questions and the maximum possible score is 68.', 'unitOfMeasure': 'Points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Tramadol Once A Day'}, {'id': 'OG001', 'title': '2 Placebo'}], 'classes': [{'title': '1 = very much improved', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': '2 = much improved', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': '3 = minimally improved', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': '4 = no change', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': '5 = minimally worse', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '6 = much worse', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '7 = very much worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': "This assessment of overall status integrates the effect of the treatment on pain, side effects, and the patient's expectation of pain relief. It is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.'}, {'type': 'SECONDARY', 'title': 'Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Tramadol Once A Day'}, {'id': 'OG001', 'title': '2 Placebo'}], 'classes': [{'title': '1 = very much improved', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': '2 = much improved', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': '3 = minimally improved', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': '4 = no change', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': '5 = minimally worse', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': '6 = much worse', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '7 = very much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Not determined', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 12', 'description': 'This assessment of overall impression of study drug is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.'}, {'type': 'SECONDARY', 'title': 'Time to Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Tramadol Once A Day'}, {'id': 'OG001', 'title': '2 Placebo'}], 'classes': [{'title': '1-point response', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '14'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '14'}]}]}, {'title': '2-point response', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '15'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '16'}]}]}, {'title': '3-point response', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '35'}, {'value': '39', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '56'}]}]}, {'title': '4-point response', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '15'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '56'}]}]}, {'title': '5-point response', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '35'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '99'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'Response was defined as a decrease of ≥1 point in an 11-point PINRS (11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) from baseline to the last visit. The time to response was estimated using Kaplan-Meier analysis and a 95% CI for the median time was calculated.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.'}, {'type': 'SECONDARY', 'title': 'Discontinuation Due to Lack of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Tramadol Once A Day'}, {'id': 'OG001', 'title': '2 Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'The number of patients who discontinued due to lack of efficacy was reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.'}, {'type': 'SECONDARY', 'title': 'Discontinuation Due to Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Tramadol Once A Day'}, {'id': 'OG001', 'title': '2 Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'The number of patients who discontinued due to adverse events (AEs). An AE is defined as any untoward medical event that occurs during the course of a clinical investigation in which a patient is administered a pharmaceutical or other therapeutic product. Its occurrence does not necessarily imply a causal relationship with the treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 Tramadol Once A Day'}, {'id': 'FG001', 'title': '2 Placebo'}], 'periods': [{'title': 'Open-label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Enrolled. Population described in the baseline characteristics is 1023 patients (Open-Label safety).', 'groupId': 'FG000', 'numSubjects': '1028'}, {'comment': 'No Placebo arm during open-label phase.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Entered run-in Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1027'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Received Open-Label Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1023'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Randomized in double-blind phase', 'groupId': 'FG000', 'numSubjects': '646'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '382'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Administrative reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not complete wash-out period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'enrolled in error (immediately D/C)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Double-blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Of the 646 patients who completed the Open-Label phase, 432 were randomized to Tramadol Once A Day', 'groupId': 'FG000', 'numSubjects': '432'}, {'comment': 'Of the 646 patients who completed the Open-Label phase, 214 were randomized to Placebo', 'groupId': 'FG001', 'numSubjects': '214'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '326'}, {'groupId': 'FG001', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '49'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Administrative reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '646', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1 Tramadol Once A Day'}, {'id': 'BG001', 'title': '2 Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '62.3', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '62.0', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '408', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 1028}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-25', 'studyFirstSubmitDate': '2009-01-29', 'resultsFirstSubmitDate': '2009-04-09', 'studyFirstSubmitQcDate': '2009-01-30', 'lastUpdatePostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-06-22', 'studyFirstPostDateStruct': {'date': '2009-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)', 'timeFrame': '12 weeks', 'description': 'The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain. The mean score at the end of the study (week 12 or time of discontinuation) was calculated.'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment', 'timeFrame': '6 weeks', 'description': 'The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain'}, {'measure': 'Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)', 'timeFrame': '12 weeks', 'description': 'Pain Intensity Score (an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) was stratified by final dose level, at week 12 or time of discontinuation. The final optimum dose level based upon efficacy and tolerability was kept for the entire study. The mean score was calculated.'}, {'measure': 'WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)', 'timeFrame': '12 weeks', 'description': 'Mean WOMAC Pain Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC pain subscale results from the sum of 5 pain questions. The maximum total score is 20.'}, {'measure': 'WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)', 'timeFrame': '12 weeks', 'description': 'Mean WOMAC Physical Function Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC Physical Function subscale results from the sum of 17 physical function questions and the maximum possible score is 68.'}, {'measure': 'Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)', 'timeFrame': '12 weeks', 'description': "This assessment of overall status integrates the effect of the treatment on pain, side effects, and the patient's expectation of pain relief. It is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)"}, {'measure': 'Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)', 'timeFrame': 'week 12', 'description': 'This assessment of overall impression of study drug is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)'}, {'measure': 'Time to Response', 'timeFrame': '12 weeks', 'description': 'Response was defined as a decrease of ≥1 point in an 11-point PINRS (11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) from baseline to the last visit. The time to response was estimated using Kaplan-Meier analysis and a 95% CI for the median time was calculated.'}, {'measure': 'Discontinuation Due to Lack of Efficacy', 'timeFrame': '12 weeks', 'description': 'The number of patients who discontinued due to lack of efficacy was reported.'}, {'measure': 'Discontinuation Due to Adverse Events', 'timeFrame': '12 weeks', 'description': 'The number of patients who discontinued due to adverse events (AEs). An AE is defined as any untoward medical event that occurs during the course of a clinical investigation in which a patient is administered a pharmaceutical or other therapeutic product. Its occurrence does not necessarily imply a causal relationship with the treatment.'}]}, 'conditionsModule': {'conditions': ['Pain', 'Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '17583466', 'type': 'RESULT', 'citation': 'Burch F, Fishman R, Messina N, Corser B, Radulescu F, Sarbu A, Craciun-Nicodin MM, Chiriac R, Beaulieu A, Rodrigues J, Beignot-Devalmont P, Duplan A, Robertson S, Fortier L, Bouchard S. A comparison of the analgesic efficacy of Tramadol Contramid OAD versus placebo in patients with pain due to osteoarthritis. J Pain Symptom Manage. 2007 Sep;34(3):328-38. doi: 10.1016/j.jpainsymman.2006.11.017. Epub 2007 Jun 21.'}], 'seeAlsoLinks': [{'url': 'http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=9048', 'label': 'Approved labelling'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit of Tramadol OAD tablets versus Placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for Open-Label phase:\n\n1. Males or females\n2. Must be between the ages of 40-80\n3. Must meet the American College of Rheumatology (ACR) Clinical Classification Criteria for Osteoarthritis of the Knee:\n\n * Current knee pain\n * Less than 30 minutes of morning stiffness with or without crepitus on active motion\n * Confirmation either by arthroscopy or radiologist's report (X-rays showing osteophytes, joint space narrowing or subchondral bone sclerosis {eburnation}) within five years prior to entry into the study\n4. Must have a history of exposure to treatment (for pain due to osteoarthritis (OA) of the knee) with Non-steroidal anti-inflammatory drugs (NSAIDs), COX II inhibitors or tramadol.\n5. Must be taking one of the above medications on a regular basis in the 30 days prior to Visit 2 (S0).\n6. Must meet the following criteria for severity of pain at Visit 2 (Day S0):\n\n * Have a score of ≥ 4 on the 11-point Numerical Rating Scale (PI-NRS; range: 0-10)\n * Have a total increase of ≥ 2 points on the 11-point Numerical Rating Scale (range: 0-10) compared to the rating at Visit 1 (Day SX)\n7. Must have a erythrocyte sedimentation rate (ESR) \\< 40 mm/hr\n8. Must have oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials\n9. Must have signed and dated an approved written Informed Consent form in French, Spanish, English or Romanian, which has also been signed and dated by the Investigator (unless otherwise required by the ethics committee), prior to study participation\n\nExclusion Criteria for Open-Label phase:\n\n1. Has known rheumatoid arthritis or any other rheumatic disease\n2. Has secondary arthritis i.e. any of the following: septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; target joint fracture; acromegaly; fibromyalgia; Wilson's disease; Ochronosis; Haemochromatosis; Osteochondromatosis; heritable arthritic disorders; or collagen gene mutations\n3. Has a history of bursitis of the knee (target knee)\n4. Has a history of pain in the ipsilateral hip (target knee)\n5. Has had a meniscal tear in the target knee within the last 12 months\n6. Has had cartilage reconstruction procedure in the target knee\n7. Has had a therapeutic arthroscopy procedure in the target knee within the last 12 months\n8. Has a Body Mass Index (BMI) greater than 37\n9. Has had a major illness, requiring hospitalisation during the 3 months before commencement of the screening period\n10. Is unwilling to stop taking pain medication other than the study medication (for arthritis or other types of pain) or is unwilling to stop taking other medications for the treatment of OA\n11. Has previously failed treatment with tramadol or discontinued treatment with tramadol due to adverse events\n12. Has been taking other opioids (e.g. codeine, oxycodone, hydromorphone, etc.) for treatment of OA or other chronic conditions\n13. Has received Corticosteroid Injections in the target knee within the last 3 months or Viscous injections in the target knee within the last 6 months\n14. Has had treatment within the last 3 weeks with any of the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors; serotonin-norepinephrine reuptake inhibitors or any other drug that reduces seizure threshold\n15. Has had treatment with another investigational agent within the last 30 days\n16. Has a history of seizure disorder other than Infantile Febrile Seizures\n17. Has a previous or current opioid dependency\n18. Has a bowel disease causing malabsorption\n19. Is pregnant, lactating or of childbearing potential and is unwilling to utilise a medically approved method of contraception during participation in this clinical trial\n20. Has significant liver disease, defined as active hepatitis or elevated liver enzymes \\>3 times the upper boundary of the normal range\n21. Has significant renal disease (defined as creatinine clearance \\<30 mL/min\n22. Has a history of current or past substance abuse or dependence, other than nicotine\n23. Has a known and documented allergy to tramadol or any structurally similar drugs (e.g. opiates)\n24. Has a known and documented allergy to acetaminophen or any structurally similar drugs\n25. Has any other condition that, in the opinion of the Investigators, would adversely affect the patient's ability to complete the study or its measures.\n\nInclusion criteria for the double-blinded phase:\n\n* Patients must continue to meet the open-label eligibility criteria and\n* Must have a score of ≥ 4 on the Numerical Rating Scale (NRS) with a total increase of ≥ 2 points on the NRS compared to Visit 3(Day R14) and\n* Must not have taken any of the prohibited medications during the Open-label Phase.\n\nExclusion criteria for the double-blinded phase:\n\n* Patient Request\n* Adverse Events that contraindicate further administration of the study medication\n* Any other situation where in the opinion of the Investigator continued participation in the study would not be in the patient's best interest."}, 'identificationModule': {'nctId': 'NCT00833794', 'briefTitle': 'A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Labopharm Inc.'}, 'orgStudyIdInfo': {'id': 'MDT3-005'}, 'secondaryIdInfos': [{'id': 'NCT00833794', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Tramadol Once A Day', 'interventionNames': ['Drug: Tramadol Once a day']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2 Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tramadol Once a day', 'type': 'DRUG', 'armGroupLabels': ['1 Tramadol Once A Day']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['2 Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Labopharm Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}