Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip

Verified by: NicOx, February 2009
First Received: October 8, 2007 | Last Updated: February 19, 2009 | Phase: Phase 3 | Start Date: June 2007
Overall Status: Completed | Estimated Enrollment: 800
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To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis...

Brief Summary

Official Title: “A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Bid and Naproxen 500 mg Bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT3012) 750 mg Bid, in Patients With Osteoarthritis of the Hip”

To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: September 2008

Detailed Clinical Trial Description

This is a 13 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen.

Intervention(s) in this Clinical Trial

  • Drug: Naproxcinod
    • 750 mg, bid
  • Drug: Naproxen
    • 500 mg, bid
  • Drug: Placebo
    • bid

Arms, Groups and Cohorts in this Clinical Trial

  • Placebo Comparator: 1
  • Active Comparator: 2
    • Naproxen 500 mg
  • Experimental: 3
    • Naproxcinod 750 mg

Outcome Measures for this Clinical Trial

Primary Measures

  • 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 hip

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Men and women (40 or older) with a diagnosis of primary OA of the hip
  • 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
  • Clinically relevant abnormal ECG
  • A history of alcohol or drug abuse
  • Diagnosis of gastric or duodenal ulceration and/or history of significant gastro‑duodenal bleeding, within the last 6 months
  • Current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy
  • Candidates for imminent joint replacement
  • Participation within 30 days prior to screening in another investigational study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: NicOx Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00541489

Study ID Number: HCT3012-X-303

ClinicalTrials.gov Identifier: NCT00541489

Health Authority: United States: Food and Drug Administration

Click here to learn more about this study - Efficacy and Safety Study of Naproxcinod in Subjects with Osteoarthritis of the Hip

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