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

Phase 3

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: ketoprofen in Diractin®; Drug: Placebo

• Registration Number: NCT00722852
• Lead Sponsor: IDEA AG

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-24
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-28
• Primary Completion: 2009-02
• Study Completion: 2009-04
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-02
• Last Update Posted: 2009-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 555

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ketoprofen in Diractin®	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
pain subscale of the WOMAC	week 12

Secondary Outcome Measures

Name	Time	Method
Patient global assessment of response to therapy	week 12
function subscale of the WOMAC	week 12

Trial Locations

Locations (37)

Hope Research Institute; 🇺🇸 Phoenix, Arizona, United States

Premiere Pharmaceutical Research; 🇺🇸 Tempe, Arizona, United States

Genova Clinical Research; 🇺🇸 Tucson, Arizona, United States

Family Practice Lynn Institute of the Ozarks; 🇺🇸 Little Rock, Arkansas, United States

Orange County Clinical Trails, Inc.; 🇺🇸 Anaheim, California, United States

Encompass Clinical Research; 🇺🇸 Spring Valley,, California, United States

Tampa Bay Medical Research Inc.; 🇺🇸 Clearwater, Florida, United States

University Clinical Research DeLand, LCC; 🇺🇸 Deland, Florida, United States

Eastern Research; 🇺🇸 Hialeah, Florida, United States

DSI; 🇺🇸 Jupiter, Florida, United States

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