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

June 16, 2011 updated by: NicOx

A Phase 3, 53 Weeks Study on Analgesic Efficacy and Safety of Naproxcinod (HCT 3012): 26-Week, Randomized, Parallel-Group, Double-Blind, Placebo (13 Weeks)- and Naproxen (26 Weeks)-Controlled, Multicenter Study of Naproxcinod (375 mg Bid and 750 mg Bid) With a 26-Week Naproxen-Controlled Safety Follow-up in Subjects With Osteoarthritis of the Knee, and a 1-week Post-treatment Safety Follow-up

To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of signs and symptoms of osteoarthritis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a 53 week study consisting in a 26 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen. The first 26 weeks will be followed by a naproxen-controlled treatment period up to 52 weeks and a 1-week post-treatment safety follow-up.

Study Type

Interventional

Enrollment (Actual)

1020

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

  • United States
    • Arizona
      • Chandler, Arizona, United States
      • Tempe, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Encino, California, United States
      • Foothill Ranch, California, United States
      • Orange, California, United States
      • Rancho Mirage, California, United States
      • Riverside, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Waterbury, Connecticut, United States
    • Florida
      • Boca Raton, Florida, United States
      • Brooksville, Florida, United States
      • Deland, Florida, United States
      • Jacksonville, Florida, United States
      • Largo, Florida, United States
      • Ocala, Florida, United States
      • Pinellas Park, Florida, United States
      • St. Petersburg, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Athens, Georgia, United States
      • Atlanta, Georgia, United States
      • Marietta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Rockford, Illinois, United States
    • Kansas
      • Prairie Village, Kansas, United States
      • Wichita, Kansas, United States
    • Kentucky
      • Erlanger, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Maryland
      • Owings Mills, Maryland, United States
    • Massachusetts
      • Wellesley HIlls, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
    • Minnesota
      • Brooklyn Center, Minnesota, United States
      • Edina, Minnesota, United States
    • Missouri
      • Florissant, Missouri, United States
      • St. Louis, Missouri, United States
    • New York
      • Rochester, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Concord, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Beachwood, Ohio, United States
      • Columbus, Ohio, United States
      • Marion, Ohio, United States
    • Oklahoma
      • Clinton, Oklahoma, United States
    • Pennsylvania
      • Altoona, Pennsylvania, United States
      • Bensalem, Pennsylvania, United States
      • Duncansville, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Clinton, South Carolina, United States
      • Goose Creek, South Carolina, United States
      • Greer, South Carolina, United States
      • Mt Pleasant, South Carolina, United States
    • Tennessee
      • Cordova, Tennessee, United States
      • Jackson, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Memphis, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Garland, Texas, United States
      • Houston, Texas, United States
      • Nederland, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States
      • Roanoke, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Lakewood, Washington, United States

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 Woman (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 anti-coagulant
  • Clinical relevant abnormal ECG
  • A history of alcohol or drug abuse
  • 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: placebo
Drug: placebo
placebo
Experimental: naproxcinod 375 mg bid
Drug: Naproxcinod 375 mg bid
Naproxcinod 375 mg bid
Experimental: naproxcinod 750 mg bid
Drug: Naproxcinod 750 mg bid
Naproxcinod 750 mg bid
Active Comparator: naproxen 500 mg bid
Drug: Naproxen 500 mg bid
Naproxen 500 mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To show that both doses of Naproxcinod (375 mg twice daily [bid] and 750 mg bid) were superior to placebo in relieving osteoarthritis (OA) signs and symptoms in subjects with OA of the knee at Week 13.
Time Frame: 13 weeks
13 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the efficacy of naproxcinod compared to naproxen 500 mg bid in relieving OA signs and symptoms in subjects with OA of the knee
Time Frame: 52 weeks
52 weeks
To evaluate the effect on blood pressure (BP) of both doses of naproxcinod, placebo, and naproxen 500 mg bid, as measured by the office BP monitoring in a population of OA subjects
Time Frame: 52 weeks
52 weeks
To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach
Time Frame: 52 weeks
52 weeks
To assess if there were any radiological changes at Week 52 in naproxcinod compared with naproxen subjects (target joint radiographs were taken at Screening and after 52 weeks of treatment, or if early termination occurred after Week 26)
Time Frame: 52 weeks
52 weeks
To compare the general safety and tolerability of both doses of naproxcinod versus naproxen 500 mg bid up to 52 weeks and with one Week post treatment follow up (Week 53)
Time Frame: 53 weeks
53 weeks

Collaborators and Investigators

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

Sponsor

NicOx

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

April 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (Estimate)

July 19, 2007

Study Record Updates

Last Update Posted (Estimate)

June 17, 2011

Last Update Submitted That Met QC Criteria

June 16, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCT 3012-X-302

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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