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

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716547
• Other study ID #: CL-033-III-03
• Status: Completed
• Phase: Phase 3
• First received: July 14, 2008
• Last updated: October 15, 2009
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: October 2009
• Source: IDEA AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics CommitteeCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlPoland: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1399
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 46 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• ketoprofen in Diractin®
50 mg (b.i.d.)
• ketoprofen in Diractin®
100 mg (b.i.d.)
• Placebo
b.i.d.
• celecoxib
100 mg (b.i.d.)

Locations

Country	Name	City	State
Czech Republic	IDEA Investigational Site	Prague 2
Germany	Klaus-Miehlke-Klinik	Wiesbaden
Poland	NZOZ Nasz Lekarz	Torun
United Kingdom	Chapel Allerton Hospital	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
IDEA AG

Countries where clinical trial is conducted

Czech Republic,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain subscale of the WOMAC		week 12	No
Secondary	Patient global assessment of response to therapy		week 12	No
Secondary	function subscale of the WOMAC		week 12	No