NCT00722852CompletedPhase 3
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
IDEA AG37 sites in 1 country555 target enrollmentStarted: June 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 555
- Locations
- 37
- Primary Endpoint
- pain subscale of the WOMAC
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 46 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
1
Experimental
Intervention: ketoprofen in Diractin® (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
pain subscale of the WOMAC
Time Frame: week 12
Secondary Outcomes
- Patient global assessment of response to therapy(week 12)
- function subscale of the WOMAC(week 12)
Investigators
Study Sites (37)
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