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

Primary Purpose

Knee Osteoarthritis

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SD-6010
SD-6010
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee, Osteoarthritis, X-ray, Joint Space Narrowing

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    200 mg

    50 mg

    Placebo

    Arm Description

    High dose active comparator

    Low dose active comparator

    Placebo comparator to be used for control purposes

    Outcomes

    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

    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.
    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
    Safety: Change from baseline to M24 in vital signs (blood pressure, heart rate) measurements will be assessed
    Safety: Change from baseline to M24 in ECG abnormalities
    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

    Full Information

    First Posted
    September 13, 2011
    Last Updated
    January 24, 2012
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01438918
    Brief Title
    X-Ray Study Investigating The Safety And Efficacy Of SD-6010 In Subjects With Osteoarthritis Of The Knee
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    Knee, Osteoarthritis, X-ray, Joint Space Narrowing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    200 mg
    Arm Type
    Active Comparator
    Arm Description
    High dose active comparator
    Arm Title
    50 mg
    Arm Type
    Active Comparator
    Arm Description
    Low dose active comparator
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo comparator to be used for control purposes
    Intervention Type
    Drug
    Intervention Name(s)
    SD-6010
    Intervention Description
    200 mg tablets once a day for 2 years
    Intervention Type
    Drug
    Intervention Name(s)
    SD-6010
    Intervention Description
    50 mg tablets once a day for 2 years
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo tablets once a day for 2 years
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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
    Title
    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
    Title
    Safety: Change from baseline to M24 in vital signs (blood pressure, heart rate) measurements will be assessed
    Time Frame
    24 months
    Title
    Safety: Change from baseline to M24 in ECG abnormalities
    Time Frame
    24 months
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6171017&StudyName=X-Ray%20Study%20Investigating%20The%20Safety%20And%20Efficacy%20Of%20SD-6010%20In%20Subjects%20With%20Osteoarthritis%20Of%20The%20Knee
    Description
    To obtain contact information for a study center near you, click here.

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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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