X-Ray Study Investigating The Safety And Efficacy Of SD-6010 In Subjects With Osteoarthritis Of The Knee
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
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2012
Longer than P75 for phase_3 knee-osteoarthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2011
CompletedFirst Posted
Study publicly available on registry
September 22, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 25, 2012
January 1, 2012
3.8 years
September 13, 2011
January 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
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
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
Study Arms (3)
200 mg
ACTIVE COMPARATORHigh dose active comparator
50 mg
ACTIVE COMPARATORLow dose active comparator
Placebo
PLACEBO COMPARATORPlacebo comparator to be used for control purposes
Interventions
Eligibility Criteria
You may qualify if:
- Subjects aged \>= 40 years Diagnosed with knee OA (ACR definition of OA) Radiographic evidence of OA in the study knee
You may not qualify if:
- A diagnosis of any other rheumatic disease Current conditions in the study knee that would confound efficacy Selected, traditional clinical safety and laboratory parameters
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2011
First Posted
September 22, 2011
Study Start
March 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 25, 2012
Record last verified: 2012-01