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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

NCT01688934 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2013-12-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-06-30
Completion
2013-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01688934 on ClinicalTrials.gov