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NCT00371670 Clinical Trial

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

Knee Osteoarthritis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00371670
Other study ID # CAAE581C2201
Secondary ID
Status Completed
Phase Phase 2
First received August 31, 2006
Last updated March 24, 2017
Start date December 2004

Study information
Verified date March 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 223
Est. completion date
Est. primary completion date July 2006
Accepts healthy volunteers
Gender All
Age group 40 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• balicatib (AAE581)

Locations
Country Name City State
Germany Novartis Nuernberg
United States Pinnacle Research Group Anniston Alabama

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in knee cartilage volume in the target compartment after 6 months
Secondary Change from baseline in:
Secondary - Cartilage volume in the different regions of the knee after 6 and 12 months,
Secondary - Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months,
Secondary - Bone marrow edema score (WORMS) in the different regions of the knee after 6 and 12 months,
Secondary - Joint space width after 6 and 12 months,
Secondary - Markers of bone and cartilage degradation (CTX-I and CTX-II at 3, 6, 9, and 12 months
Secondary - 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
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