A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee (ITIC)
Tracking Information
Start Date ICMJE | December 2007 |
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Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: June 16, 2008) | 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 ] |
Original Primary Outcome Measures ICMJE (submitted: November 29, 2007) | Assessing the progression rate of joint space narrowing in the study knee of women diagnosed with knee OA over a 24-month period. |
Change History | Complete list of historical versions of study NCT00565812 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: June 16, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: November 29, 2007) |
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Descriptive Information
Brief Title ICMJE | A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee |
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Official Title ICMJE | 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 |
Brief Summary | 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. |
Detailed Description | |
Study Phase | Phase II, Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Osteoarthritis |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 1400 | ||||
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Estimated Completion Date | January 2012 | ||||
Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 40 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Belgium, Canada, Czech Republic, Germany, Hungary, Italy, Peru, Poland, Russian Federation, Slovakia, Spain |
Administrative Information
NCT ID ICMJE | NCT00565812 | ||||
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Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
Study ID Numbers ICMJE | A6171016 | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/