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

IDEA AG

Status and phase

Completed

Phase 2

Conditions

Osteoarthritis, Knee

Treatments

Drug: IDEA-033

Study type

Interventional

Funder types

Industry

Identifiers

NCT00211549

CL-033-III-04

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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