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Completed

NCT Number: NCT00542555

Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee

To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This is a 13-week double-blind study followed by a 52-week, open-label, roll-over on active treatment study. These are randomized, parallel group, multicenter studies comparing efficacy and safety of naproxcinod, placebo and naproxen.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women (40 or older) with a diagnosis of primary OA of the knee
  • Must be a current chronic user of NSAIDS or acetaminophen
  • Must discontinue all analgesic therapy at screening

Exclusion criteria

  • Uncontrolled hypertension or diabetes
  • Hepatic or renal impairment
  • Current or expected use of anticoagulant
  • A history of alcohol or drug abuse
  • Candidates for imminent joint replacement
  • Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
  • Current medical disease that could confound or interfere with the evaluation of efficacy
  • Participation within 30 days prior to screening in another investigational study

Treatment and study plan

Placebo

Drug

At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study.

Naproxcinod 375 mg

Drug

Naproxen

Drug

Naproxcinod 750 mg

Drug

Primary outcomes

  1. The primary objective of this study is to show that naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the knee at 13 weeks and to collect long term safety data

    Time frame: 13 weeks / long term

Sponsors and collaborators

Lead sponsor

NicOx

Industry

Registry information

Official study title

301: A Phase 3 Study of the Analgesic Efficacy and Safety of HCT 3012: A Parallel, Randomized, Double Blind, 13 Week Placebo and Naproxen Controlled, Multicenter Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Patients With Osteoarthritis of the Knee, Followed by Its Extension (301E): A Parallel, Randomized, Open-Label, Multicenter, 52-Week Follow-up Safety Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Subjects With Osteoarthritis of the Knee

Important dates

Study start
2005
Study completion
2007
First posted
Oct 11, 2007
Registry last updated
Jun 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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