NCT00716547CompletedPhase 3
Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Study of Safety and Efficacy of Two Dosages of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee
IDEA AG4 sites in 4 countries1,399 target enrollmentStarted: May 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 1,399
- Locations
- 4
- 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 50 mg and 100 mg ketoprofen in Diractin®.
Detailed Description
The study will investigate safety and efficacy of 2 dosages of Diractin®at relieving the 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, celecoxib, sulfonamides and ingredients used in pharmaceutical products including galactose
- •Peripheral arterial disease and/or cerebrovascular disease
- •History of stroke or myocardial infarction
- •Congestive Heart failure NYHA Class II-IV
- •History of pancreatitis or peptic ulcers;
- •Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
- •Serum creatinine levels > 2.5 milligrams/deciliter (mg/dL)
- •ALT or AST levels ≥ 5 times the ULN
- •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
Experimental
Intervention: ketoprofen in Diractin® (Drug)
3
Active Comparator
Intervention: celecoxib (Drug)
4
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 (4)
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