| A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee |
| 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 |
| 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. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Osteoarthritis |
- Drug: SD-6010
200 mg tablets once a day for 2 years
- Drug: SD-6010
50 mg tablets once a day for 2 years
- Drug: Placebo
Placebo tablets once a day for 2 years
|
- Active Comparator: 200 mg
High dose active comparator
Intervention: Drug: SD-6010
- Active Comparator: 50 mg
Low dose active comparator
Intervention: Drug: SD-6010
- Placebo Comparator: Placebo
Placebo comparator to be used for control purposes
Intervention: Drug: Placebo
|
| Hellio le Graverand MP, Clemmer RS, Redifer P, Brunell RM, Hayes CW, Brandt KD, Abramson SB, Manning PT, Miller CG, Vignon E. A 2-year randomised, double-blind, placebo-controlled, multicentre study of oral selective iNOS inhibitor, cindunistat (SD-6010), in patients with symptomatic osteoarthritis of the knee. Ann Rheum Dis. 2013 Feb;72(2):187-95. doi: 10.1136/annrheumdis-2012-202239. Epub 2012 Nov 10. |
| |
| Completed |
| 1457 |
| November 2011 |
| October 2011 (Final data collection date for primary outcome measure) |
|
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
|
| Sexes Eligible for Study: |
All |
|
| 40 Years to 99 Years (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Australia, Belgium, Canada, Czech Republic, Germany, Hungary, Italy, Peru, Poland, Russian Federation, Slovakia, Spain, United States |
| |
| |
| NCT00565812 |
A6171016
2007-001457-26 ( EudraCT Number )
ITIC ( Other Identifier: Alias Study Number ) |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| November 2016 |
