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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00565812

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis	Drug: SD-6010 Drug: Placebo	Phase II Phase III

MedlinePlus related topics: Osteoarthritis X-Rays

Drug Information available for: X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Long-Term, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Radiographic Study to Investigate the Safety and Efficacy of Orally Administered SD-6010 in Subjects With Symptomatic Osteoarthritis of the Knee

Further study details as provided by Pfizer:

Primary Outcome Measures:

Assessing the progression rate of joint space narrowing in the study knee of subjects diagnosed with knee OA over a 24-month period. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessing the safety and tolerability of multiple doses of SD-6010 administered long-term in subjects diagnosed with knee OA; [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Assessing the clinical benefit of multiple doses of SD-6010 in subjects diagnosed with knee OA [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1400
Study Start Date:	December 2007
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
200 mg: Active Comparator High dose active comparator	Drug: SD-6010 200 mg tablets once a day for 2 years
50 mg: Active Comparator Low dose active comparator	Drug: SD-6010 50 mg tablets once a day for 2 years
Placebo: Placebo Comparator Placebo comparator to be used for control purposes	Drug: Placebo Placebo tablets once a day for 2 years

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565812

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 146 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6171016
Study First Received:	November 29, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00565812
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

knee Osteoarthritis, Disease Modifying Osteoarthritis Drug

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 15, 2009