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This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01438918
First received: September 13, 2011
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety: Change from baseline to M24 in vital signs (blood pressure, heart rate) measurements will be assessed [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Safety: Change from baseline to M24 in ECG abnormalities [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438918

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01438918     History of Changes
Other Study ID Numbers: A6171017
Study First Received: September 13, 2011
Last Updated: January 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Knee
Osteoarthritis
X-ray
Joint Space Narrowing

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

ClinicalTrials.gov processed this record on April 17, 2014