Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-28 @ 12:09 AM
Study NCT ID:
NCT01688934
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2012-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595012', 'term': '4-(3-chloro-5-(1,2-dihydroxyethyl)-2-pyridyl)-N-(5-(trifluoromethyl)-2-pyridyl)-3,6-dihydro-2H-pyridine-1-carboxamide'}, {'id': 'D009288', 'term': 'Naproxen'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-04', 'studyFirstSubmitDate': '2012-09-17', 'studyFirstSubmitQcDate': '2012-09-17', 'lastUpdatePostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster OA Index (WOMAC) Pain Score', 'timeFrame': 'Week 4'}], 'secondaryOutcomes': [{'measure': 'WOMAC Physical Function Score', 'timeFrame': 'Week 4'}, {'measure': 'WOMAC Stiffness Score', 'timeFrame': 'Week 4'}, {'measure': 'Modified Brief Pain Inventory - Short Form (mBPI-SF) Severity of Pain and Interference of Pain', 'timeFrame': 'Week 4'}, {'measure': 'Patient Global Impression of Change (PGIC)', 'timeFrame': 'Week 4'}, {'measure': 'Supplemental Analgesic Medication Use', 'timeFrame': 'Over 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pain', 'Osteoarthritis', 'Knee'], 'conditions': ['Osteoarthritis, Knee', 'Pain']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Subjects with moderate pain due to OA of the knee as their primary pain condition.\n2. Subjects with diagnostic criteria for primary pain condition (American college of Rheumatology \\[ACR\\] clinical and radiographic criteria):\n\n * At least 1 of the following in addition to knee pain: age \\>50, stiffness \\<30 min, crepitus on active motion, and\n * Kellgren-Lawrence (K-L) grade ≥ 2 radiographic evidence within the past 2 years.\n\nKey Exclusion Criteria:\n\n1. Subjects with chronic pain conditions other than OA of the knee as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area.\n2. Subjects who cannot or will not agree to stop all concomitant analgesic medications, apart from specified protocol supplemental analgesic medications.\n3. Subjects with history of seizures within the past 5 years.\n4. Subjects who use opioids more than 4 days per week.\n5. Pain-condition-specific exclusions:\n\n * Subjects who received local pain-control procedures, including intra- articular steroid injection in the study knee or intramuscular steroid injection at any site within 6 weeks of entering the study or hyaluronate injection in the study knee within 12 weeks of entering the study.\n6. Subjects who have had arthroscopy on either knee or hip within 6 months of entering the study, or open surgery on either knee or hip within 12 months of entering the study.\n7. Active-comparator-related exclusions:\n\n * Subjects who are allergic to or cannot tolerate naproxen or acetaminophen, including history of NSAID-induced asthma, or nasal polyps;\n * Subjects with history of bleeding disorders or history of documented gastrointestinal ulcer disease.\n\nOther protocol specific inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01688934', 'briefTitle': 'Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Purdue Pharma LP'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'VND2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V116517 - 50 mg', 'description': 'V116517 50-mg tablets', 'interventionNames': ['Drug: V116517 50-mg tablets', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'V116517 - 30 mg', 'description': 'V116517 30-mg tablets', 'interventionNames': ['Drug: V116517 30-mg tablets', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Naproxen 500 mg', 'description': 'Naproxen 500-mg capsules', 'interventionNames': ['Drug: Naproxen 500-mg capsules', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'V116517 50-mg tablets', 'type': 'DRUG', 'description': 'Taken orally twice daily', 'armGroupLabels': ['V116517 - 50 mg']}, {'name': 'V116517 30-mg tablets', 'type': 'DRUG', 'description': 'Taken orally twice daily', 'armGroupLabels': ['V116517 - 30 mg']}, {'name': 'Naproxen 500-mg capsules', 'type': 'DRUG', 'description': 'Taken orally twice daily', 'armGroupLabels': ['Naproxen 500 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily', 'armGroupLabels': ['Naproxen 500 mg', 'Placebo', 'V116517 - 30 mg', 'V116517 - 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Genova Clinical Research, Inc.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Orthopedic Research Institute', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Avail Clinical Research, LLC', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '32205', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Westside Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Health Awareness, Inc.', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research, LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32765', 'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research East, LLC', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'zip': '46383', 'city': 'Valparaiso', 'state': 'Indiana', 'country': 'United States', 'facility': 'Northwest Indiana Center for Clinical Research', 'geoPoint': {'lat': 41.47309, 'lon': -87.06114}}, {'zip': '01760', 'city': 'Natick', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Analgesic Solutions', 'geoPoint': {'lat': 42.28343, 'lon': -71.3495}}, {'zip': '48706', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Great Lakes Research Group, Inc.', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '28209', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Charlotte, LLC.', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Raleigh, LLC', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates, LLC', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '73069', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'LION Research', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '19610', 'city': 'Wyomissing', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Research Center of Reading, LLP', 'geoPoint': {'lat': 40.32954, 'lon': -75.96521}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': 'PMG Research of Bristol', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue Pharma LP', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}