Clinical trial NCT00716547: Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Lead sponsor: IDEA AG
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 1399
Sex: ALL
Minimum age (years): 46
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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, 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

Primary outcomes:
measure: pain subscale of the WOMAC
timeFrame: week 12
Secondary outcomes:
measure: Patient global assessment of response to therapy
timeFrame: week 12
measure: function subscale of the WOMAC
timeFrame: week 12
Other outcomes:
Locations:
city: Prague 2
country: Czech Republic
facility: IDEA Investigational Site
city: Wiesbaden
country: Germany
facility: Klaus-Miehlke-Klinik
city: Torun
country: Poland
facility: NZOZ Nasz Lekarz
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
Study officials:
affiliation: IDEA AG
name: IDEA AG Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Conaghan PG, Dickson J, Bolten W, Cevc G, Rother M. A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis. Rheumatology (Oxford). 2013 Jul;52(7):1303-12. doi: 10.1093/rheumatology/ket133. Epub 2013 Mar 28.