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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00541489
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : February 20, 2009
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Brief Summary:
To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis.

Condition or disease Intervention/treatment Phase
Osteoarthritis Osteoarthritis, Hip Drug: Naproxcinod Drug: Naproxen Drug: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2007
Actual Primary Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo

Active Comparator: 2
Naproxen 500 mg
Drug: Naproxen
500 mg, bid

Experimental: 3
Naproxcinod 750 mg
Drug: Naproxcinod
750 mg, bid

Primary Outcome Measures :
  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 hip

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00541489

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Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00541489     History of Changes
Other Study ID Numbers: HCT3012-X-303
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009

Keywords provided by NicOx:
Osteoarthritis, Hip

Additional relevant MeSH terms:
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Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen-n-butyl nitrate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nitric Oxide Donors