Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee

Completed · Phase 2

Conditions studied: Knee Osteoarthritis

In brief

This study will test efficacy and safety of AAE581 compared to placebo in limiting cartilage loss in patients with painful knee osteoarthritis which is confirmed by X-ray

Key facts

Study ID

NCT00371670

Run by

Novartis Pharmaceuticals

People needed

223

Starts

2004-12-01

Last updated by the study team

2017-03-28

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least one knee with osteoarthritis with Kellgren-Lawrence grade 3
• Significant osteoarthritis pain in the knee
• Presence of at least one of the risk factors: obesity (BMI > 28), osteoarthritis at other sites, knee effusion, family history of total joint replacement

You may not qualify if…

• Women with childbearing potential
• Secondary osteoarthritis
• Treatment with intra-articular or systemic steroids
• Inability to undergo MRI acquisition
• Other protocol defined inclusion/exclusion criteria may apply.

Where it is running

• Pinnacle Research Group — Anniston, Alabama, United States
• Novartis — Nuremberg, Germany

Full record on ClinicalTrials.gov

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