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X-Ray Study Investigating The Safety And Efficacy Of SD-6010 In Subjects With Osteoarthritis Of The Knee

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: September 13, 2011
Last updated: January 24, 2012
Last verified: January 2012
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.

Condition Intervention Phase
Knee Osteoarthritis Drug: SD-6010 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Long-term, Confirmatory, Phase 3, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study To Investigate The Safety And Efficacy Of Orally Administered Sd-6010 In Subjects With Symptomatic Osteoarthritis Of The Knee

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To assess the progression rate of joint space narrowing in the study knee of subjects with knee OA over a 24-month period [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 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 [ Time Frame: 24 months ]
  • Safety: Change from baseline to M24 in vital signs (blood pressure, heart rate) measurements will be assessed [ Time Frame: 24 months ]
  • Safety: Change from baseline to M24 in ECG abnormalities [ Time Frame: 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 [ Time Frame: 6 months ]

Enrollment: 0
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 200 mg
High dose active comparator
Drug: SD-6010
200 mg tablets once a day for 2 years
Active Comparator: 50 mg
Low dose active comparator
Drug: SD-6010
50 mg tablets once a day for 2 years
Placebo Comparator: Placebo
Placebo comparator to be used for control purposes
Drug: Placebo
Placebo tablets once a day for 2 years


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01438918

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01438918     History of Changes
Other Study ID Numbers: A6171017
Study First Received: September 13, 2011
Last Updated: January 24, 2012

Keywords provided by Pfizer:
Joint Space Narrowing

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on June 22, 2017