Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis
Brief 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.
Detailed 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
Interventions
DRUGIDEA-033
Sponsors
IDEA AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed