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Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee

CompletedPhase 2NCT01688934
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.

Study details

Official title
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
Interventions
  • Drug: V116517 50-mg tablets
  • Drug: V116517 30-mg tablets
  • Drug: Naproxen 500-mg capsules
  • Drug: Placebo
Sponsor
Purdue Pharma LP
Start date
2012-09
Primary completion
2013-06
Sex
All
Age range
from 40 Years to 80 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
18

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Key Inclusion Criteria: 1. Subjects with moderate pain due to OA of the knee as their primary pain condition. 2. Subjects with diagnostic criteria for primary pain condition (American college of Rheumatology \[ACR\] clinical and radiographic criteria): * At least 1 of the following in addition to knee pain: age \>50, stiffness \<30 min, crepitus on active motion, and * Kellgren-Lawrence (K-L) grade ≥ 2 radiographic evidence within the past 2 years. Key Exclusion Criteria: 1. 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. 2. Subjects who cannot or will not agree to stop all concomitant analgesic medications, apart from specified protocol supplemental analgesic medications. 3. Subjects with history of seizures within the past 5 years. 4. Subjects who use opioids more than 4 days per week. 5. Pain-condition-specific exclusions: * 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. 6. 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. 7. Active-comparator-related exclusions: * Subjects who are allergic to or cannot tolerate naproxen or acetaminophen, including history of NSAID-induced asthma, or nasal polyps; * Subjects with history of bleeding disorders or history of documented gastrointestinal ulcer disease. Other protocol specific inclusion/exclusion criteria may apply.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01688934