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

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ClinicalTrials.gov Identifier: NCT01438918
Recruitment Status : Withdrawn
First Posted : September 22, 2011
Last Update Posted : January 25, 2012
Information provided by (Responsible Party):

Study Description
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). 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 or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: SD-6010 Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : March 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. Safety: Change from baseline to M24 in vital signs (blood pressure, heart rate) measurements will be assessed [ Time Frame: 24 months ]
  4. Safety: Change from baseline to M24 in ECG abnormalities [ Time Frame: 24 months ]
  5. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438918

Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01438918     History of Changes
Other Study ID Numbers: A6171017
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: January 2012

Keywords provided by Pfizer:
Joint Space Narrowing

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases