NCT01688934

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Osteoarthritis, Knee
• Pain

Interventions

Type	Name	Description
DRUG	V116517 50-mg tablets	Taken orally twice daily
DRUG	V116517 30-mg tablets	Taken orally twice daily
DRUG	Naproxen 500-mg capsules	Taken orally twice daily
DRUG	Placebo	Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-06-01
• Completion: 2013-08-01
• First posted: 2012-09-20
• Last updated: 2013-12-05

Locations

18 sites across 1 country: United States