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

February 19, 2009 updated by: NicOx

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 3M7
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 1T4
      • Coquitlam, British Columbia, Canada, V3K 3P4
      • Vancouver, British Columbia, Canada, V5Z 1K3
    • Ontario
      • Corunna, Ontario, Canada, N0N 1G0
      • Kitchener, Ontario, Canada, N2M 5N6
      • Mississauga, Ontario, Canada, L4T 4J2
      • Newmarket, Ontario, Canada, L3Y 5G8
      • Toronto, Ontario, Canada, M9W 4L6
    • Quebec
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 3X1
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
      • Montgomery, Alabama, United States, 36106
      • Tuscaloosa, Alabama, United States, 35406
    • Arizona
      • Chandler, Arizona, United States, 85224
      • Mesa, Arizona, United States, 85213
      • Phoenix, Arizona, United States, 85016
    • California
      • Fair Oaks, California, United States, 95628
      • San Diego, California, United States, 92120
      • Santa Barbara, California, United States, 93111
    • Colorado
      • Northglenn, Colorado, United States, 80234
    • Florida
      • Coral Gables, Florida, United States, 33134
      • Daytona Beach, Florida, United States, 32117
      • Deland, Florida, United States, 32720
      • Fort Meyers, Florida, United States, 33916
      • Jupiter, Florida, United States, 33458
    • Kentucky
      • Louisville, Kentucky, United States, 40291
    • Massachusetts
      • Peabody, Massachusetts, United States, 01960
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
      • Saginaw, Michigan, United States, 48602
    • New Jersey
      • Berlin, New Jersey, United States, 08009
      • Dover, New Jersey, United States, 07801
    • New York
      • Rochester, New York, United States, 14609
    • Ohio
      • Cincinnati, Ohio, United States, 45224
      • Cleveland, Ohio, United States, 44122
      • Franklin, Ohio, United States, 45005
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
      • Penndel, Pennsylvania, United States, 19047
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
    • South Carolina
      • Anderson, South Carolina, United States, 29621
      • Columbia, South Carolina, United States, 29204
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
    • Texas
      • Austin, Texas, United States, 78705
      • Nederland, Texas, United States, 77627
      • San Antonio, Texas, United States, 78217
    • Virginia
      • Newport News, Virginia, United States, 23606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Drug: Placebo
bid
Active Comparator: 2
Naproxen 500 mg
Drug: Naproxen
500 mg, bid
Experimental: 3
Naproxcinod 750 mg
Drug: Naproxcinod
750 mg, bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NicOx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

October 8, 2007

First Submitted That Met QC Criteria

October 9, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Estimate)

February 20, 2009

Last Update Submitted That Met QC Criteria

February 19, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCT3012-X-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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