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

Condition(s) targeted: Osteoarthritis; Osteoarthritis, Hip

Intervention: Naproxcinod (Drug); Naproxen (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: NicOx

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

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Primary outcome: 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

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

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Quebec G1V 3M7, Canada

Tuscaloosa, Alabama 35406, United States

Montgomery, Alabama 36106, United States

Mobile, Alabama 36608, United States

Chandler, Arizona 85224, United States

Phoenix, Arizona 85016, United States

Mesa, Arizona 85213, United States

Burnaby, British Columbia V5G 1T4, Canada

Vancouver, British Columbia V5Z 1K3, Canada

Coquitlam, British Columbia V3K 3P4, Canada

Santa Barbara, California 93111, United States

Fair Oaks, California 95628, United States

San Diego, California 92120, United States

Northglenn, Colorado 80234, United States

Daytona Beach, Florida 32117, United States

Fort Meyers, Florida 33916, United States

Deland, Florida 32720, United States

Coral Gables, Florida 33134, United States

Jupiter, Florida 33458, United States

Louisville, Kentucky 40291, United States

Peabody, Massachusetts 01960, United States

Saginaw, Michigan 48602, United States

Kalamazoo, Michigan 49009, United States

Dover, New Jersey 07801, United States

Berlin, New Jersey 08009, United States

Rochester, New York 14609, United States

Cleveland, Ohio 44122, United States

Franklin, Ohio 45005, United States

Cincinnati, Ohio 45224, United States

Bethany, Oklahoma 73008, United States

Kitchener, Ontario N2M 5N6, Canada

Newmarket, Ontario L3Y 5G8, Canada

Toronto, Ontario M9W 4L6, Canada

Corunna, Ontario N0N 1G0, Canada

Mississauga, Ontario L4T 4J2, Canada

Penndel, Pennsylvania 19047, United States

Duncansville, Pennsylvania 16635, United States

Trois-Rivieres, Quebec G8Z 1Y2, Canada

Warwick, Rhode Island 02886, United States

Regina, Saskatchewan S4P 3X1, Canada

Saskatoon, Saskatchewan S7K 3H3, Canada

Columbia, South Carolina 29204, United States

Anderson, South Carolina 29621, United States

Kingsport, Tennessee 37660, United States

San Antonio, Texas 78217, United States

Austin, Texas 78705, United States

Nederland, Texas 77627, United States

Newport News, Virginia 23606, United States

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

Starting date: June 2007
Last updated: June 5, 2008