A Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for the Treatment of Osteoarthritis of the Knee

March 19, 2009 updated by: IDEA AG

A Double-Blind, Long-Term Evaluation of the Safety of IDEA-033 in Comparison to Oral Naproxen for the Treatment of the Signs and Symptoms of Osteoarthritis of the Knee

The purpose of this study is to evaluate the long-term safety of IDEA-033 (an anti-inflammatory pain-relieving drug applied to the skin) in comparison to naproxen (an anti-inflammatory pain-relieving drug taken by mouth) for the treatment of osteoarthritis of both knees.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, active-controlled study of the safety of IDEA-033 in comparison to oral naproxen for the treatment of the signs and symptoms of osteoarthritis of the knee in patients who have completed Study 17-007 or who have discontinued Study 17-007 due to lack of efficacy. If a sufficient number of patients do not enroll from Study 17-007, patients with osteoarthritis of both knees who were not enrolled in Study 17-007 may be enrolled in this study. Patients treated with IDEA-033 in Study 17-007 will receive 100 mg per knee of ketoprofen gel twice daily and one placebo capsule twice daily for 52 weeks. Patients treated with oral naproxen or placebo in Study 17-007 will receive a 500 mg naproxen over-encapsulated tablet twice daily and placebo topical gel twice daily for 52 weeks. Patients who did not participate in Study 17-007 will be randomized to receive one of these two treatments. The primary outcomes of the study include the incidence and severity of adverse events, dermal-irritation scores, and changes in routine clinical laboratory tests and vital signs obtained at each visit.

Patients assigned to IDEA-033 in Study 17-007 will topically apply 100 mg per knee of ketoprofen gel twice daily and take one oral placebo capsule twice daily for 52 weeks. Patients assigned to oral naproxen or placebo in Study 17-007 will take one 500 mg naproxen over-encapsulated tablet orally twice daily and apply placebo topical gel twice daily for 52 weeks. Patients who did not participate in Study 17-007 will be randomized to receive one of these two treatments.

Study Type

Interventional

Enrollment

550

Phase

  • Phase 2

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
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Capstone Clinical Trials Inc
      • Montgomery, Alabama, United States, 36101
      • Montgomery, Alabama, United States, 36124
      • Northport, Alabama, United States, 35476
    • Arizona
      • Mesa, Arizona, United States, 85206
      • Phoenix, Arizona, United States, 85032
      • Tempe, Arizona, United States, 85258
    • California
      • Anaheim, California, United States, 92801
      • Encinitas, California, United States, 92024
      • Fair Oaks, California, United States, 95628
      • Garden Grove, California, United States, 92840
      • Irvine, California, United States, 92618
      • Paramount, California, United States, 90723
      • Rancho Mirage, California, United States, 92270
      • San Diego, California, United States, 92120
      • Spring Valley, California, United States, 91978
      • Vista, California, United States, 92083
    • Colorado
      • Northglenn, Colorado, United States, 80234
    • Connecticut
      • Danbury, Connecticut, United States, 06810
    • Florida
      • Clearwater, Florida, United States, 33761
      • Coral Gables, Florida, United States, 33134
      • Daytona Beach, Florida, United States, 32114
        • Radiant Research-daytona
      • Deland, Florida, United States, 32720
      • Fort Myers, Florida, United States, 33916
      • Gainesville, Florida, United States, 32607
      • Hialeah, Florida, United States, 33013
        • The Community Research of South Florida
      • Ocala, Florida, United States, 34474
      • Ocala, Florida, United States, 34471
      • Ocoee, Florida, United States, 34761
      • Palm Harbor, Florida, United States, 34684
      • Pembroke Pines, Florida, United States, 33024
      • Port Orange, Florida, United States, 32127
      • Tampa, Florida, United States, 33614
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Atlanta, Georgia, United States, 30329
      • Atlanta, Georgia, United States, 21286
        • International Research Center
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Kansas
      • Arkansas City, Kansas, United States, 67005
      • Newton, Kansas, United States, 67114
      • Wichita, Kansas, United States, 67205
    • Kentucky
      • Louisville, Kentucky, United States, 40291
    • Massachusetts
      • Milford, Massachusetts, United States, 01757
    • Michigan
      • East Lansing, Michigan, United States, 48910
      • Kalamazoo, Michigan, United States, 49009
      • Lansing, Michigan, United States, 48917
    • Mississippi
      • Flowood, Mississippi, United States, 39232
      • Jackson, Mississippi, United States, 39202
    • Montana
      • Bozeman, Montana, United States, 59715
    • Nevada
      • Las Vegas, Nevada, United States, 89102
    • New Jersey
      • Berlin, New Jersey, United States, 08009
      • Dover, New Jersey, United States, 07801
    • New York
      • Binghamton, New York, United States, 13901
      • Manilus, New York, United States, 13104
      • Rochester, New York, United States, 14609
    • North Carolina
      • Durham, North Carolina, United States, 27704
      • Winston Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinatti, Ohio, United States, 45227
        • Community Research Managment Associates
      • Cincinnati, Ohio, United States, 45219
      • Cincinnati, Ohio, United States, 45236
      • Cincinnati, Ohio, United States, 45224
      • Columbus, Ohio, United States, 43215
      • Columbus, Ohio, United States, 43212
      • Franklin, Ohio, United States, 45005
      • Perrysburg, Ohio, United States, 43551
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • Gilbert Medical Research
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
      • Bensalem, Pennsylvania, United States, 19020
      • Duncansville, Pennsylvania, United States, 16635
      • Harleysville, Pennsylvania, United States, 19438
      • Levittown, Pennsylvania, United States, 19057
      • Penndel, Pennsylvania, United States, 19047
      • Philadelphia, Pennsylvania, United States, 19152
      • Pittsburgh, Pennsylvania, United States, 15219
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
    • South Carolina
      • Anderson, South Carolina, United States, 29621
      • Charleston, South Carolina, United States, 29407
      • Columbia, South Carolina, United States, 29204
      • Greer, South Carolina, United States, 29651
    • Tennessee
      • Memphis, Tennessee, United States, 38120
    • Texas
      • Austin, Texas, United States, 78758
      • Dallas, Texas, United States, 75231
      • Dallas, Texas, United States, 75234
      • Dallas, Texas, United States, 75235
      • Houston, Texas, United States, 77024
      • Lake Jackson, Texas, United States, 77566
      • San Antonio, Texas, United States, 78217
      • San Antonio, Texas, United States, 78209
    • Utah
      • Salt Lake City, Utah, United States, 84124
      • Salt Lake City, Utah, United States, 84102
    • Washington
      • Spokane, Washington, United States, 99202
      • Spokane, Washington, United States, 99207
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who completed Study 17-007 or discontinued from Study 17-007 due to lack of efficacy
  • Patients who did not complete or discontinue from Study 17-007 must have osteoarthritis of both knees for a minimum of six months
  • Have moderate pain in the most involved knee when not taking non-steroidal anti-inflammatory drugs (NSAIDs)
  • Must have used an oral NSAID on at least three days per week for the last three months, or 25 of the 30 days before screening
  • Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last six months

Exclusion Criteria:

  • Any patient currently receiving physical therapy to either knee or having a history of allergy, hypersensitivity or contraindication to ketoprofen, naproxen, or acetaminophen, an NSAID idiosyncrasy, or any other medical condition that would compromise the ability of the subject to complete the required assessments and visits
  • For patients who did not participate in Study 17-007: having Grade 1 or Grade 4 severity of the most involved knee based on x-ray criteria
  • Received intra-articular injections or arthroscopy of the most involved knee during three months before screening visit
  • Have a large bulging effusion, or have inflammation of the most involved knee that could be related to gout, pseudogout-induced synovitis, or infection
  • Have a history of partial or total knee replacement in either knee, or have a history of gout, pseudo-gout induced synovitis, or infection of the more severe knee

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events; Dermal-irritation scores; Changes in routine clinical laboratory tests and vital signs obtained at each visit.

Secondary Outcome Measures

Outcome Measure
Change from baseline (Week 12 for patients who completed 17-007, baseline for those who did not) and mean value per visit for WOMAC pain, stiffness, and physical function scores; Subject Global Assessment of Response to Therapy.

Collaborators and Investigators

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

Sponsor

IDEA AG

Investigators

  • Study Director: IDEA AG Clinical Trial, IDEA AG

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

July 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

December 13, 2005

First Submitted That Met QC Criteria

December 13, 2005

First Posted (Estimate)

December 14, 2005

Study Record Updates

Last Update Posted (Estimate)

March 20, 2009

Last Update Submitted That Met QC Criteria

March 19, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-033-III-05

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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