NCT03028870

A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled and Active-controlled, Parallel-group Study Evaluating the Analgesic Efficacy and Safety of V120083 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
DRUG	V120083	Capsules
DRUG	Naproxen	Capsules
DRUG	Placebo	Capsules to match V120083 and/or naproxen

Timeline

• Start date: 2017-03-14
• Primary completion: 2017-11-10
• Completion: 2017-11-21
• First posted: 2017-01-23
• Last updated: 2019-02-12
• Results posted: 2018-11-15

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study