An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee

March 19, 2009 updated by: IDEA AG

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Three Doses 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 identify the dose(s) of IDEA-033 that will provide a meaningful effect for treating osteoarthritis of the knee.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this double-blind, placebo-controlled, randomized study is to evaluate the safety of and to identify the dose(s) of IDEA-033 that will provide a minimum clinically meaningful effect for treating the signs and symptoms of osteoarthritis of the knee. This study will also compare the safety profile of the three doses of IDEA-033 in treating the signs and symptoms associated with osteoarthritis for 12 weeks. The primary hypothesis is that at least one of the three doses of IDEA-033 is superior to placebo with respect to three primary efficacy endpoints of WOMAC Pain, WOMAC Physical Function, and Subject Global Assessment of Response to Therapy. A second hypothesis is that there is an increase in efficacy with increasing doses of IDEA-033.

Patients will receive one of five treatments for 12 weeks:Three doses of IDEA-033, or naproxen 1 g over-encapsulated tablet + placebo or placebo

Study Type

Interventional

Enrollment

875

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
      • Montgomery, Alabama, United States, 36101
      • Montgomery, Alabama, United States, 36124
        • Drug Research and Analysis Corporation
      • 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
      • Temecula, California, United States, 92591
      • 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
      • Deland, Florida, United States, 32720
      • Fort Lauderdale, Florida, United States, 33334
      • Fort Myers, Florida, United States, 33916
      • Gainesville, Florida, United States, 32607
      • Hialeah, Florida, United States, 33013
      • Jacksonville, Florida, United States, 32216
      • 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
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Kansas
      • Arkansas City, Kansas, United States, 67005
      • Kansas City, Kansas, United States, 66109
      • Newton, Kansas, United States, 67114
      • Wichita, Kansas, United States, 67205
    • Kentucky
      • Louisville, Kentucky, United States, 40291
    • Maryland
      • Towson, Maryland, United States, 21286
    • 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
    • Missouri
      • Kansas City, Missouri, United States, 00000
    • 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
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates L L C
      • Wilmington, North Carolina, United States, 28412
      • 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
      • Colombus, 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
    • 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:

  • Osteoarthritis of both knees for minimum of six months
  • Moderate pain in the most involved knee when not taking NSAIDs
  • Must have used an oral NSAID on at least three days per week for last three months or 25 of 30 days before screening
  • Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last six months

Exclusion Criteria:

  • Grade 1 or Grade 4 severity of the most involved knee based on x-ray criteria
  • Intra-articular injections or arthroscopy of the most involved knee during three months before Screening visit
  • Inflammation of the most involved knee that could be related to gout or pseudogout-induced synovitis or infection
  • A large bulging effusion
  • History of gout or pseudo-gout induced synovitis or infection of the more severe knee
  • History of partial or total knee replacement in either 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
Change from baseline at Week 12 on pain subscale and physical function subscale on the WOMAC Osteoarthritis Index. Subject global assessment of response to therapy (SGART) on a five-point Likert scale at Week 12.

Secondary Outcome Measures

Outcome Measure
Change from baseline at Weeks 2, 6, 9 for WOMAC pain and physical function scores and SGART. Mean change from baseline for the entire on-therapy period for WOMAC pain and physical function scores and SGART.

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

June 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 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-04

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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