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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). 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 mg | Active Comparator | High dose active comparator |
|
| 50 mg | Active Comparator | Low dose active comparator |
|
| Placebo | Placebo Comparator | Placebo comparator to be used for control purposes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SD-6010 | Drug | 200 mg tablets once a day for 2 years |
| |
| SD-6010 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the progression rate of joint space narrowing in the study knee of subjects with knee OA over a 24-month period | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefit of SD 6010 will be measured from changes in response from baseline to 24 months in 7 patient reported outcomes (PRO), including, but not limited to, WOMAC, pain VAS, ICOAP, KOOS. | 24 months | |
| Total analgesic medication burden for OA in the study knee will be compared back to baseline of an increased, sustained use of standard background and/or rescue medication for more than 30 days as measured at the Month 12 and 24 visits |
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Inclusion Criteria:
Subjects aged >= 40 years Diagnosed with knee OA (ACR definition of 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
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C578791 | cindunistat |
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| Drug |
50 mg tablets once a day for 2 years |
|
| Placebo | Drug | Placebo tablets once a day for 2 years |
|
| 24 months |
| Safety: Change from baseline to M24 in vital signs (blood pressure, heart rate) measurements will be assessed | 24 months |
| Safety: Change from baseline to M24 in ECG abnormalities | 24 months |
| Safety: In a subset of subjects: Change from baseline on average as assessed by 24-h ambulatory blood pressure monitoring (ABPM) at months 3 and 6 | 6 months |