Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-01-01 @ 4:52 AM
Study NCT ID:
NCT00772967
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2008-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009288', 'term': 'Naproxen'}, {'id': 'C478659', 'term': 'Ultracet'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse experiences (AEs) were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed.', 'description': 'AEs were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants treated with at least one dose of Placebo', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Naproxen', 'description': 'Participants treated with at least one dose of Naproxen', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ultracet', 'description': 'Participants treated with at least one dose of Ultracet. Two participants were not treated due to discontinuation.', 'otherNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants treated with at least one dose of Placebo'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Participants treated with at least one dose of Naproxen'}, {'id': 'OG002', 'title': 'Ultracet', 'description': 'Participants treated with at least one dose of Ultracet.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.927', 'groupId': 'OG000', 'lowerLimit': '-1.52', 'upperLimit': '-0.33'}, {'value': '-1.54', 'groupId': 'OG001', 'lowerLimit': '-2.12', 'upperLimit': '-0.96'}, {'value': '-1.73', 'groupId': 'OG002', 'lowerLimit': '-2.34', 'upperLimit': '-1.12'}]}]}], 'analyses': [{'pValue': '0.089', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.611', 'ciLowerLimit': '-1.36', 'ciUpperLimit': '0.14', 'pValueComment': '1-sided, alpha = 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk', 'testedNonInferiority': False}, {'pValue': '0.043', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.804', 'ciLowerLimit': '-1.57', 'ciUpperLimit': '-0.04', 'pValueComment': '1-sided, alpha = 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 3', 'description': 'Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over 20 minute self paced walks at 4 and 6 hrs post-dose. The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the two TWA (0-20 minutes) PI from the self-paced walks on Day 3 is reported as units on a scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who provided baseline and at least one on-treatment observation'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants treated with at least one dose of Placebo'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Participants treated with at least one dose of Naproxen'}, {'id': 'OG002', 'title': 'Ultracet', 'description': 'Participants treated with at least one dose of Ultracet.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.438', 'groupId': 'OG000', 'lowerLimit': '-0.98', 'upperLimit': '0.11'}, {'value': '-0.956', 'groupId': 'OG001', 'lowerLimit': '-1.51', 'upperLimit': '-0.40'}, {'value': '-1.47', 'groupId': 'OG002', 'lowerLimit': '-2.02', 'upperLimit': '-0.92'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.518', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.01', 'pValueComment': '1-sided, alpha = 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-1.03', 'ciLowerLimit': '-1.54', 'ciUpperLimit': '-0.53', 'pValueComment': '1-sided, alpha = 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 1', 'description': 'Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over 20 minute self-paced walks at 2, 4, and 6 hrs post-dose . The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the three TWA (0-20 minutes)PI from the self-paced walks on Day 1 is reported as units on a scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who provided baseline and at least one on-treatment observation'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants treated with at least one dose of Placebo'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Participants treated with at least one dose of Naproxen'}, {'id': 'OG002', 'title': 'Ultracet', 'description': 'Participants treated with at least one dose of Ultracet.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.150', 'groupId': 'OG000', 'lowerLimit': '-0.52', 'upperLimit': '0.82'}, {'value': '-0.508', 'groupId': 'OG001', 'lowerLimit': '-1.18', 'upperLimit': '0.17'}, {'value': '-1.00', 'groupId': 'OG002', 'lowerLimit': '-1.67', 'upperLimit': '-0.34'}]}]}], 'analyses': [{'pValue': '0.052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.658', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '0.01', 'pValueComment': '1-sided, alpha = 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-1.15', 'ciLowerLimit': '-1.81', 'ciUpperLimit': '-0.49', 'pValueComment': '1-sided, alpha = 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 1', 'description': 'Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes,rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over a 20 minute high-paced treadmill walk at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 1 is reported as units on a scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who provided baseline and at least one on-treatment observation'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants treated with at least one dose of Placebo'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Participants treated with at least one dose of Naproxen'}, {'id': 'OG002', 'title': 'Ultracet', 'description': 'Participants treated with at least one dose of Ultracet.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.234', 'groupId': 'OG000', 'lowerLimit': '-0.85', 'upperLimit': '0.38'}, {'value': '-1.11', 'groupId': 'OG001', 'lowerLimit': '-1.71', 'upperLimit': '-0.51'}, {'value': '-1.30', 'groupId': 'OG002', 'lowerLimit': '-1.93', 'upperLimit': '-0.67'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-0.875', 'ciLowerLimit': '-1.56', 'ciUpperLimit': '-0.19', 'pValueComment': '1-sided, alpha = 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '90', 'paramValue': '-1.07', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '-0.37', 'pValueComment': '1-sided, alpha = 0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 3', 'description': 'Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over a 20 minute high-paced treadmill walk, at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 3 is reported as units on a scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who provided baseline and at least one on-treatment observation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo, Naproxen, Ultracet', 'description': 'Placebo in Treatment Period 1, Naproxen in Treatment Period 2, Ultracet in Treatment Period 3.'}, {'id': 'FG001', 'title': 'Naproxen, Ultracet, Placebo', 'description': 'Naproxen in Treatment Period 1, Ultracet in Treatment Period 2, Placebo in Treatment Period 3.'}, {'id': 'FG002', 'title': 'Ultracet, Placebo, Naproxen', 'description': 'Ultracet in Treatment Period 1, Placebo in Treatment Period 2, Naproxen in Treatment Period 3.'}, {'id': 'FG003', 'title': 'Placebo, Ultracet, Naproxen', 'description': 'Placebo in Treatment Period 1, Ultracet in Treatment Period 2, Naproxen in Treatment Period 3.'}, {'id': 'FG004', 'title': 'Naproxen, Placebo, Ultracet', 'description': 'Naproxen in Treatment Period 1, Placebo in Treatment Period 2, Ultracet inTreatment Period 3.'}, {'id': 'FG005', 'title': 'Ultracet, Naproxen, Placebo', 'description': 'Ultracet in Treatment Period 1, Naproxen in Treatment Period 2, Placebo in Treatment Period 3.'}], 'periods': [{'title': 'Crossover Treatment 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'comment': 'The withdrawal is not included in any outcomes; but is part of the Adverse Event group for placebo', 'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event (Pain)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Break 1 (4-7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Crossover Treatment 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Break 2 (4-7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Crossover Treatment 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First Patient Entered: 23 June 2008\n\nLast Patient, Last Visit: 20 November 2008\n\n2 sites', 'preAssignmentDetails': 'Inclusion criteria: Patient has osteoarthritis of the knee and primary source of pain is knee\n\nTitration schedule for Ultracet® (Acetaminophen 325 mg and tramadol hydrochloride 37.5 mg): twice on Day 1, three times on Day 2, and twice on the morning of Day 3.\n\nNaproxen tablets 500 mg twice daily on Days 1 and 2 and 500 mg once daily on Day 3.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All randomized participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '7.92', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-16', 'studyFirstSubmitDate': '2008-10-13', 'resultsFirstSubmitDate': '2009-11-19', 'studyFirstSubmitQcDate': '2008-10-13', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-06', 'studyFirstPostDateStruct': {'date': '2008-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 3', 'timeFrame': 'Baseline and Day 3', 'description': 'Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over 20 minute self paced walks at 4 and 6 hrs post-dose. The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the two TWA (0-20 minutes) PI from the self-paced walks on Day 3 is reported as units on a scale.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 1', 'timeFrame': 'Baseline and Day 1', 'description': 'Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over 20 minute self-paced walks at 2, 4, and 6 hrs post-dose . The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the three TWA (0-20 minutes)PI from the self-paced walks on Day 1 is reported as units on a scale.'}, {'measure': 'Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 1', 'timeFrame': 'Baseline and Day 1', 'description': 'Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes,rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over a 20 minute high-paced treadmill walk at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 1 is reported as units on a scale.'}, {'measure': 'Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 3', 'timeFrame': 'Baseline and Day 3', 'description': 'Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over a 20 minute high-paced treadmill walk, at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 3 is reported as units on a scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '20175977', 'type': 'DERIVED', 'citation': 'Peeva E, Beals CR, Bolognese JA, Kivitz AJ, Taber L, Harman A, Smugar SS, Moskowitz RW. A walking model to assess the onset of analgesia in osteoarthritis knee pain. Osteoarthritis Cartilage. 2010 May;18(5):646-53. doi: 10.1016/j.joca.2009.12.008. Epub 2010 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate a walking model of osteoarthritis for use in testing of new therapeutic agents. The primary hypothesis is that participants treated with Naproxen or Ultracet will have lower Pain Intensity (PI) than those treated with Placebo during self-paced walks on Day 3 of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has osteoarthritis of the knee and primary source of pain is knee\n* Females must not be pregnant or nursing and must agree to use birth control throughout the study\n* Is willing to limit alcohol and caffeine intake\n* Is willing to abstain from smoking during study visits\n* Must be able to walk on a treadmill at a pace of at least 1 mile/hour\n\nExclusion Criteria:\n\n* Has a medical/arthritic disease that would interfere with evaluation\n* Is unable to take naproxen or Ultracet\n* Has congestive heart failure or angina\n* Has a history of stroke\n* Has a history of uncontrolled high blood pressure\n* Has a history of cancer\n* Regularly uses a walker or cane'}, 'identificationModule': {'nctId': 'NCT00772967', 'briefTitle': 'A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Evaluate the Analgesic Effects of Naproxen and Ultracet in a Walking Model of Osteoarthritis Knee Pain', 'orgStudyIdInfo': {'id': '0000-105'}, 'secondaryIdInfos': [{'id': '2008_566', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo, Naproxen, Ultracet', 'description': 'Participants were treated with Placebo for 3 days in Treatment Period 1, Naproxen for 3 days in Treatment Period 2, and Ultracet for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.', 'interventionNames': ['Drug: Naproxen', 'Drug: Placebo', 'Drug: Ultracet']}, {'type': 'EXPERIMENTAL', 'label': 'Naproxen, Ultracet, Placebo', 'description': 'Participants were treated with Naproxen for 3 days in Treatment Period 1, Ultracet for 3 days in Treatment Period 2, and Placebo for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.', 'interventionNames': ['Drug: Naproxen', 'Drug: Placebo', 'Drug: Ultracet']}, {'type': 'EXPERIMENTAL', 'label': 'Ultracet, Placebo, Naproxen', 'description': 'Participants were treated with Ultracet for 3 days in Treatment Period 1, Placebo for 3 days in Treatment Period 2, and Naproxen for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.', 'interventionNames': ['Drug: Naproxen', 'Drug: Placebo', 'Drug: Ultracet']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo, Ultracet, Naproxen', 'description': 'Participants were treated with Placebo for 3 days in Treatment Period 1, Ultracet for 3 days in Treatment Period 2, and Naproxen for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.', 'interventionNames': ['Drug: Naproxen', 'Drug: Placebo', 'Drug: Ultracet']}, {'type': 'EXPERIMENTAL', 'label': 'Naproxen, Placebo, Ultracet', 'description': 'Participants were treated with Naproxen for 3 days in Treatment Period 1, Placebo for 3 days in Treatment Period 2, and Ultracet for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.', 'interventionNames': ['Drug: Naproxen', 'Drug: Placebo', 'Drug: Ultracet']}, {'type': 'EXPERIMENTAL', 'label': 'Ultracet, Naproxen, Placebo', 'description': 'Participants were treated with Ultracet for 3 days in Treatment Period 1, Naproxen for 3 days in Treatment Period 2, and Placebo for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.', 'interventionNames': ['Drug: Naproxen', 'Drug: Placebo', 'Drug: Ultracet']}], 'interventions': [{'name': 'Naproxen', 'type': 'DRUG', 'description': 'Naproxen tablets 500 mg twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Twice daily on Day 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.', 'armGroupLabels': ['Naproxen, Placebo, Ultracet', 'Naproxen, Ultracet, Placebo', 'Placebo, Naproxen, Ultracet', 'Placebo, Ultracet, Naproxen', 'Ultracet, Naproxen, Placebo', 'Ultracet, Placebo, Naproxen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Three times daily on Day 2, and 2 capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.', 'armGroupLabels': ['Naproxen, Placebo, Ultracet', 'Naproxen, Ultracet, Placebo', 'Placebo, Naproxen, Ultracet', 'Placebo, Ultracet, Naproxen', 'Ultracet, Naproxen, Placebo', 'Ultracet, Placebo, Naproxen']}, {'name': 'Ultracet', 'type': 'DRUG', 'description': 'Ultracet (tramadol/acetaminophen) 37.5/325 mg/mg capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Three times daily on Day 2, and two 37.5/325 mg capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.', 'armGroupLabels': ['Naproxen, Placebo, Ultracet', 'Naproxen, Ultracet, Placebo', 'Placebo, Naproxen, Ultracet', 'Placebo, Ultracet, Naproxen', 'Ultracet, Naproxen, Placebo', 'Ultracet, Placebo, Naproxen']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}