A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in overweight and obese subjects with knee osteoarthritis. The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.

Key facts

Study ID

NCT00565812

Run by

Pfizer

People needed

1457

Starts

2007-11-01

Expected to finish

2011-11-01

Last updated by the study team

2016-12-30

Who can join

Age: 40 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects aged >= 40 years with a BMI >= 25 and <= 40 kg/m2
• In the past, has been diagnosed with knee OA
• Radiographic evidence of OA in the study knee

You may not qualify if…

• A diagnosis of any other rheumatic disease
• Current conditions in the study knee that would confound efficacy
• Selected, traditional clinical safety and laboratory parameters

Where it is running

• Pivotal Research Centers — Peoria, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Pivotal Research Centers — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Martin Bowen Hefley Orthopedics — Little Rock, Arkansas, United States
• Teton Research, LLC — Little Rock, Arkansas, United States
• Med Center — Carmichael, California, United States
• College Hospital Costa Mesa — Costa Mesa, California, United States
• NeuroNetwork Trials — Costa Mesa, California, United States
• Med Investigations, Inc. — Fair Oaks, California, United States
• Sierra Clinical Research — Roseville, California, United States
• University of California Davis Health System — Sacramento, California, United States
• University of California Davis — Sacramento, California, United States
• Scripps Clinic-Clinical Research — San Diego, California, United States
• Plaza Medical Imaging — Santa Ana, California, United States
• Denver Internal Medicine Group — Denver, Colorado, United States
• Mountain View Clinical Research, Inc. — Denver, Colorado, United States
• New West Physicians Clinical Research — Golden, Colorado, United States
• Advanced Radiology Consultants — Fairfield, Connecticut, United States
• Advanced Radiology Consultants — Stamford, Connecticut, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• New England Research Associates, LLC — Trumbull, Connecticut, United States
• Southeastern Arthritis Center — Gainesville, Florida, United States
• Southeastern Imaging & Diagnostics — Gainesville, Florida, United States
• Greystone Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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