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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00371670
Recruitment Status : Completed
First Posted : September 4, 2006
Last Update Posted : March 28, 2017
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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

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: balicatib (AAE581) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : December 2004
Actual Primary Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Primary Outcome Measures :
  1. Change from baseline in knee cartilage volume in the target compartment after 6 months

Secondary Outcome Measures :
  1. Change from baseline in:
  2. - Cartilage volume in the different regions of the knee after 6 and 12 months,
  3. - Cartilage score (Whole Organ MRI Scoring system (WORMS)) in the different regions of the knee after 6 and 12 months,
  4. - Bone marrow edema score (WORMS) in the different regions of the knee after 6 and 12 months,
  5. - Joint space width after 6 and 12 months,
  6. - Markers of bone and cartilage degradation (CTX-I and CTX-II at 3, 6, 9, and 12 months
  7. - 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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00371670

United States, Alabama
Pinnacle Research Group
Anniston, Alabama, United States, 36207
Nuernberg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00371670     History of Changes
Other Study ID Numbers: CAAE581C2201
First Posted: September 4, 2006    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Keywords provided by Novartis:
Knee, osteoarthritis, pain, disease modifying

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases