Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)

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

The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Drug: ketoprofen in Diractin®; Drug: ketoprofen in Diractin®; Drug: celecoxib; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 1399
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czech Republic
  • Prague 2, Czech Republic, 128 50
    • IDEA Investigational Site
• Germany
  • Wiesbaden, Germany, 65191
    • Klaus-Miehlke-Klinik
• Poland
  • Torun, Poland, 87-100
    • NZOZ Nasz Lekarz
• United Kingdom
  • Leeds, United Kingdom, LS7 4SA
    • Chapel Allerton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: ketoprofen in Diractin®; 100 mg (b.i.d.); Drug: ketoprofen in Diractin®; 50 mg (b.i.d.)
Experimental: 2	Drug: ketoprofen in Diractin®; 100 mg (b.i.d.); Drug: ketoprofen in Diractin®; 50 mg (b.i.d.)
Placebo Comparator: 4	Drug: Placebo; b.i.d.
Active Comparator: 3	Drug: celecoxib; 100 mg (b.i.d.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pain subscale of the WOMAC	week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient global assessment of response to therapy	week 12
function subscale of the WOMAC	week 12

Collaborators and Investigators

• Sponsor: IDEA AG
• Investigators: Study Director: IDEA AG Clinical Trial, IDEA AG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: July 14, 2008
• First Submitted That Met QC Criteria: July 15, 2008
• First Posted (Estimate): July 16, 2008

Study Record Updates

• Last Update Posted (Estimate): October 16, 2009
• Last Update Submitted That Met QC Criteria: October 15, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib; Ketoprofen
• Other Study ID Numbers: CL-033-III-03