search
Back to results

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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ketoprofen in Diractin®
Placebo
Sponsored by
IDEA AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee

Eligibility Criteria

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

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

Sites / Locations

  • Hope Research Institute
  • Premiere Pharmaceutical Research
  • Genova Clinical Research
  • Family Practice Lynn Institute of the Ozarks
  • Orange County Clinical Trails, Inc.
  • Encompass Clinical Research
  • Tampa Bay Medical Research Inc.
  • University Clinical Research DeLand, LCC
  • Eastern Research
  • DSI
  • FPA Clinical Research
  • Suncoast Clinical Research Family Practice
  • Renstar Medical Research
  • University Clinical Research, Inc.
  • Miami Research Associates
  • Non-Surgical Orthopaedic & Spine Center, P.C.
  • Drug Studies America
  • Clinical Research Atlanta
  • Advance Clinical Research Insititute
  • MediSphere Medical Research Center, LLC
  • Integrated Clinical Trail Services, Inc.
  • Lousianna Research Associates Inc. (LRC, Inc)
  • Future Care Studies
  • Westside Family Medical Center, P.C.
  • Omaha Research, P.C.
  • Rochester Clinical Research
  • Wake Research Associates, LLC
  • The Center of Clinical Research LLC
  • Rapid Medical Research, Inc.
  • Pharcotherapy Research Associate, Inc.
  • Altoona Center for Clinical Research
  • Founders Research Group Research
  • Omega Medical Research
  • Coastal Carolina Research Center
  • Sarah Cannon Research Institute
  • Quality Research Inc.
  • Progressive Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

pain subscale of the WOMAC

Secondary Outcome Measures

Patient global assessment of response to therapy
function subscale of the WOMAC

Full Information

First Posted
July 24, 2008
Last Updated
October 2, 2009
Sponsor
IDEA AG
search

1. Study Identification

Unique Protocol Identification Number
NCT00722852
Brief Title
Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
IDEA AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
555 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ketoprofen in Diractin®
Intervention Description
100 mg (b.i.d.)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
100 mg (b.i.d.)
Primary Outcome Measure Information:
Title
pain subscale of the WOMAC
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Patient global assessment of response to therapy
Time Frame
week 12
Title
function subscale of the WOMAC
Time Frame
week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IDEA AG
Organizational Affiliation
IDEA AG
Official's Role
Study Director
Facility Information:
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Premiere Pharmaceutical Research
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Genova Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Family Practice Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Orange County Clinical Trails, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley,
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Tampa Bay Medical Research Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
University Clinical Research DeLand, LCC
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Eastern Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
DSI
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
FPA Clinical Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Suncoast Clinical Research Family Practice
City
New Port Richey,
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
University Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Non-Surgical Orthopaedic & Spine Center, P.C.
City
Marietta,
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge,
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Advance Clinical Research Insititute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Integrated Clinical Trail Services, Inc.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Lousianna Research Associates Inc. (LRC, Inc)
City
New Orleans,
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Future Care Studies
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Westside Family Medical Center, P.C.
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Omaha Research, P.C.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68116
Country
United States
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
The Center of Clinical Research LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Pharcotherapy Research Associate, Inc.
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Founders Research Group Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Coastal Carolina Research Center
City
Goose Creek,
State/Province
South Carolina
ZIP/Postal Code
29445
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Quality Research Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23996292
Citation
Rother M, Conaghan PG. A randomized, double-blind, phase III trial in moderate osteoarthritis knee pain comparing topical ketoprofen gel with ketoprofen-free gel. J Rheumatol. 2013 Oct;40(10):1742-8. doi: 10.3899/jrheum.130192. Epub 2013 Sep 1.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs