Status:
COMPLETED
Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT00371670
Start Date
December 1 2004
Last Update
March 28 2017
Active Locations (2)
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1
Pinnacle Research Group
Anniston, Alabama, United States, 36207
2
Novartis
Nuremberg, Germany