Anaheim, California 92801

  • Osteoarthritis, Knee

Purpose:

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 summary:

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


Criteria:

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 is Available At:


Original ID:

CL-033-III-04


NCT ID:

NCT00211549


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

IDEA AG


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

875


Enrollment Type:


Overall Contact Information

Official Name:IDEA AG Clinical Trial
Study Director
IDEA AG

Study Dates

Start Date:June 2005
Verification Date:March 2009
Last Changed Date:March 19, 2009
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary 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.
Safety Issues:False
Outcome Type:Secondary 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.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:IDEA-033

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:IDEA AG

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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