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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00371670
First received: August 31, 2006
Last updated: May 18, 2009
Last verified: May 2009

August 31, 2006
May 18, 2009
December 2004
July 2006   (final data collection date for primary outcome measure)
Change from baseline in knee cartilage volume in the target compartment after 6 months
Same as current
Complete list of historical versions of study NCT00371670 on ClinicalTrials.gov Archive Site
  • Change from baseline in:
  • - Cartilage volume in the different regions of the knee after 6 and 12 months,
  • - Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months,
  • - Bone marrow edema score (WORMS) in the different regions of the knee after 6 and 12 months,
  • - Joint space width after 6 and 12 months,
  • - Markers of bone and cartilage degradation (CTX-I and CTX-II at 3, 6, 9, and 12 months
  • - Pain (analgesic consumption, Western Ontario and McMaster Universities Osteoarthritis Index, Visual Analogue Scale, criteria of the Outcome Measures in Rheumatology Osteoarthritis-Research Society International at 1, 3, 6, 9, and 12 months
  • Change from baseline in:
  • – Cartilage volume in the different regions of the knee after 6 and 12 months,
  • – Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months,
  • – Bone marrow edema score (WORMS) in the different regions of the knee after 6 and 12 months,
  • – Joint space width after 6 and 12 months,
  • – Markers of bone and cartilage degradation (CTX-I and CTX-II at 3, 6, 9, and 12 months
  • – Pain (analgesic consumption, Western Ontario and McMaster Universities Osteoarthritis Index, Visual Analogue Scale, criteria of the Outcome Measures in Rheumatology Osteoarthritis-Research Society International at 1, 3, 6, 9, and 12 months
Not Provided
Not Provided
 
Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee
A Phase II, 12-Month, Double-Blind, Placebo-Controlled, Dose-Finding, Multicenter Study to Evaluate the Safety, Tolerability, and Disease Modifying Efficacy of Daily Oral AAE581 (10, 25 and 50 mg Tablets) in Patients With Painful Knee Osteoarthritis, Kellgren-Lawrence Grade 3 by X-Ray

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Knee Osteoarthritis
Drug: balicatib (AAE581)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
223
Not Provided
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Both
40 Years to 80 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany,   United States
 
NCT00371670
CAAE581C2201
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP