Expired Study
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Montgomery, Alabama 36101


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


NCT ID:

NCT00211549


Primary Contact:

Study Director
IDEA AG Clinical Trial
IDEA AG


Backup Contact:

N/A


Location Contact:

Montgomery, Alabama 36101
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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