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

IDEA AG875 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

875

Conditions

Osteoarthritis, Knee

Interventions

IDEA-033DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (100)

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Montgomery, Alabama, United States

Drug Research and Analysis Corporation

Montgomery, Alabama, United States

Unnamed facility

Northport, Alabama, United States

Unnamed facility

Mesa, Arizona, United States

Unnamed facility

Phoenix, Arizona, United States

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Tempe, Arizona, United States

Unnamed facility

Anaheim, California, United States

Unnamed facility

Encinitas, California, United States

Unnamed facility

Fair Oaks, California, United States

...and 90 more locations