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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211549
• Other study ID #: CL-033-III-04
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: March 19, 2009
• Start date: June 2005

Study information

• Verified date: March 2009
• Source: IDEA AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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

Other known NCT identifiers

• NCT00371917

Recruitment information / eligibility

• Status: Completed
• Enrollment: 875
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• IDEA-033

Locations

Country	Name	City	State
United States	Community Research Managment Associates	Cincinatti	Ohio
United States	Cumberland Research Associates L L C	Fayetteville	North Carolina
United States	Drug Research and Analysis Corporation	Montgomery	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
IDEA AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.