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IDEA-033 Three Months Dose Finding in OA Followed by IDEA-033 Three Months Extension in OA

Primary Purpose

Osteoarthritis; Knee

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
IDEA-033 (and rescue medication)
Sponsored by
IDEA AG
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis; Knee focused on measuring osteoarthritis; knee; IDEA-033

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: clinical diagnosis of OA in at least one knee for a minimum of 6 months aged 18-75 years old eligible subjects must have used an oral or rectal NSAID on at least three days per week during the three months before screening or on at least 25 of the 30 days before screening, but be dissatisfied with the current NSAID treatment at baseline visit WOMAC pain subscale at least 40 mm, and at least 15 mm greater than at the screening visit in the index knee radiographic evidence consistent with OA criteria of grade 2 or 3 according to Kellgren & Lawrence in the index knee. Radiographs mus have been taken during the 6 months before baseline. American College of Rheumatology (ACR) functional class I, II or III Exclusion Criteria: intraarticular injections or arthroscopy of the index knee within 3 months prior to screening, or planned during the study history, physical examinations or radiographs suggestive of other rhematic diseases known hypersensitivity or contraindication to ketoprofen; NSAID idiosyncrasy history of peptic ulcers severe liver or gastro-intestinal disease within the last 6 months injections or change in oral treatment regimen of glucosamine, chondroitin sulfate, hyaluronic acid, shark cartilage, or vitamin E within 3 months prior to screening oral or parenteral corticosteroids within 3 months prior to screening analgesic therapy for chronic or recurrent pain conditions for indications other than OA immunosuppressants within 3 months prior to screening

Sites / Locations

    Outcomes

    Primary Outcome Measures

    change from baseline at week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC Pain subscale (primary)
    patient global assessment of response to therapy measured on a 5-point Likert Scale at week 12 or end of study measurements (co-primary)
    change from baseline at week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC function subscale (co-primary)

    Secondary Outcome Measures

    Change from baseline at week 12 (or end of study measurements) for Physician's Global Assessment of OA and for observed function (TUG)
    Mean number of rescue medication taken per day while in the study
    Number of withdrawals and time to discontinuation of the study due to lack of efficacy
    Time to onset (in days) of pain relief and time to onset of new flares during treatment
    Change from baseline on the vitality subscale of the SF-36 health survey and the EURO QoL

    Full Information

    First Posted
    April 19, 2006
    Last Updated
    March 19, 2009
    Sponsor
    IDEA AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00316784
    Brief Title
    IDEA-033 Three Months Dose Finding in OA Followed by IDEA-033 Three Months Extension in OA
    Official Title
    A Double-Blind, Placebo-Controlled Evaluation of Dose Related Safety and Efficacy of Epicutaneously Applied IDEA-033 for 3 Months Treatment of OA of the Knee Followed by a Double-Blind, Dose-Controlled Evaluation of Safety and Efficacy of Epicutaneously Applied IDEA-033 for 12 Weeks Treatment of OA of the Knee
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    IDEA AG

    4. Oversight

    5. Study Description

    Brief Summary
    The study objective is the eluciation of the dose-response function in efficacy (and possibly safety) in order to determine an optimal dose with respect to efficacy and safety. The study is designed with three dose levels and one placebo control.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis; Knee
    Keywords
    osteoarthritis; knee; IDEA-033

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    704 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    IDEA-033 (and rescue medication)
    Primary Outcome Measure Information:
    Title
    change from baseline at week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC Pain subscale (primary)
    Title
    patient global assessment of response to therapy measured on a 5-point Likert Scale at week 12 or end of study measurements (co-primary)
    Title
    change from baseline at week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC function subscale (co-primary)
    Secondary Outcome Measure Information:
    Title
    Change from baseline at week 12 (or end of study measurements) for Physician's Global Assessment of OA and for observed function (TUG)
    Title
    Mean number of rescue medication taken per day while in the study
    Title
    Number of withdrawals and time to discontinuation of the study due to lack of efficacy
    Title
    Time to onset (in days) of pain relief and time to onset of new flares during treatment
    Title
    Change from baseline on the vitality subscale of the SF-36 health survey and the EURO QoL

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: clinical diagnosis of OA in at least one knee for a minimum of 6 months aged 18-75 years old eligible subjects must have used an oral or rectal NSAID on at least three days per week during the three months before screening or on at least 25 of the 30 days before screening, but be dissatisfied with the current NSAID treatment at baseline visit WOMAC pain subscale at least 40 mm, and at least 15 mm greater than at the screening visit in the index knee radiographic evidence consistent with OA criteria of grade 2 or 3 according to Kellgren & Lawrence in the index knee. Radiographs mus have been taken during the 6 months before baseline. American College of Rheumatology (ACR) functional class I, II or III Exclusion Criteria: intraarticular injections or arthroscopy of the index knee within 3 months prior to screening, or planned during the study history, physical examinations or radiographs suggestive of other rhematic diseases known hypersensitivity or contraindication to ketoprofen; NSAID idiosyncrasy history of peptic ulcers severe liver or gastro-intestinal disease within the last 6 months injections or change in oral treatment regimen of glucosamine, chondroitin sulfate, hyaluronic acid, shark cartilage, or vitamin E within 3 months prior to screening oral or parenteral corticosteroids within 3 months prior to screening analgesic therapy for chronic or recurrent pain conditions for indications other than OA immunosuppressants within 3 months prior to screening
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gerold Stucki, Prof, MD
    Organizational Affiliation
    department of physical medicine and rehabilitation of universtity Munich
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    IDEA-033 Three Months Dose Finding in OA Followed by IDEA-033 Three Months Extension in OA

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