Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee

October 2, 2009 updated by: IDEA AG

Multicentre, Randomized, Double-blind, Placebo-controlled Study of Safety and Efficacy of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee

The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in Diractin®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will investigate safety and efficacy of Diractin® at relieving signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.

Study Type

Interventional

Enrollment (Actual)

555

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • HOPE Research Institute
      • Tempe, Arizona, United States, 85282
        • Premiere Pharmaceutical Research
      • Tucson, Arizona, United States, 85741
        • Genova Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Family Practice Lynn Institute of the Ozarks
    • California
      • Anaheim, California, United States, 92801
        • Orange County Clinical Trails, Inc.
      • Spring Valley,, California, United States, 91978
        • Encompass Clinical Research
    • Florida
      • Clearwater, Florida, United States, 33761
        • Tampa Bay Medical Research Inc.
      • Deland, Florida, United States, 32720
        • University Clinical Research DeLand, LCC
      • Hialeah, Florida, United States, 33458
        • Eastern Research
      • Jupiter, Florida, United States, 33458
        • DSI
      • Kissimmee, Florida, United States, 34741
        • FPA Clinical Research
      • New Port Richey,, Florida, United States, 34652
        • Suncoast Clinical Research Family Practice
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research, Inc.
      • South Miami, Florida, United States, 33143
        • Miami Research Associates
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Drug Studies America
      • Marietta,, Georgia, United States, 30060
        • Non-Surgical Orthopaedic & Spine Center, P.C.
      • Stockbridge,, Georgia, United States, 30281
        • Clinical Research Atlanta
    • Idaho
      • Boise, Idaho, United States, 83704
        • Advance Clinical Research Insititute
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Integrated Clinical Trail Services, Inc.
    • Louisiana
      • New Orleans,, Louisiana, United States, 70114
        • Lousianna Research Associates Inc. (LRC, Inc)
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Future Care Studies
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Westside Family Medical Center, P.C.
    • Nebraska
      • Omaha, Nebraska, United States, 68116
        • Omaha Research, P.C.
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • The Center of Clinical Research LLC
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc.
      • Zanesville, Ohio, United States, 43701
        • Pharcotherapy Research Associate, Inc.
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Philadelphia, Pennsylvania, United States, 19152
        • Founders Research Group Research
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Goose Creek,, South Carolina, United States, 29445
        • Coastal Carolina Research Center
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Sarah Cannon Research Institute
    • Texas
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research
      • San Antonio, Texas, United States, 78209
        • Quality Research Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent signed and dated
  • Age > 45 years
  • Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee

Exclusion Criteria:

  • Skin lesions or dermatological diseases in the treatment area
  • Directly or indirectly involved in the conduct and administration of this study
  • Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin®
  • Pregnancy or lactation
  • Residents of psychiatric wards, prisons or other state institutions
  • Malignancy within the past 2 years
  • Depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study
  • Epilepsy
  • Schizophrenia
  • Neuropathic pain and any other pain condition requiring chronic use of pain medication
  • Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen and to ingredients of the IMP
  • Preexisting asthma or bronchospasm after taking aspirin or other NSAIDs
  • Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ketoprofen in Diractin®
100 mg (b.i.d.)
Placebo Comparator: 2
Drug: Placebo
100 mg (b.i.d.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain subscale of the WOMAC
Time Frame: week 12
week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient global assessment of response to therapy
Time Frame: week 12
week 12
function subscale of the WOMAC
Time Frame: week 12
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IDEA AG

Investigators

  • Study Director: IDEA AG, IDEA AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

July 24, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (Estimate)

July 28, 2008

Study Record Updates

Last Update Posted (Estimate)

October 5, 2009

Last Update Submitted That Met QC Criteria

October 2, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-033-III-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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