A double blind, placebo-controlled evaluation of dose realted safety and efficacy of epicutaneously applied IDEA-033 for 3 months treatment of osteoarthritis of the knee - IDEA-033 three months dose finding in OA

Phase 1

• Conditions: Osteoarthritis of the knee joint

• Registration Number: EUCTR2004-004993-95-GB
• Lead Sponsor: IDEA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-13
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Informed consent
Age 18-75
Clinical diagnosis of osteoarthritis (OA) in at least one knee for a mimumum of 6 months
Eligible subjects must have used an oral or rectal NSAID on at least three days per week during the three months before screening or on at least 25 of the 30 days before screening, but be dissatisfied with the current NSAID treatment.
At baseline, subjects must have a WOMAC Pain subscale greater than or equal to 40mm, and at least 15mm greater than at the screeningvisit in the index knee
Radiographic evidence of OA, as specified in the protocol
ACR functional class I, II or III
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Coagulopathy
Pregnancy and lactation
Skin lkesions or dermatological diseases in the tre4atment areas
Any other investigational medicinal product within 90 days prior to screening
Intra-articular injections or arthroscopy of the index knee within 3 months prior to screening, or planned during the study
Malignancy within the past 2 years
History, physical examinations or radiographs suggestive of other rheumatic diseases
Known hypersensitivity or contraindications to ketoprofen; NSAID idiosyncrasy
History of peptic ulcers
Severe liver or gastro-intestinal disease within the last 6 months
History of clinically important renal, cardiovascula or neurological diseases
Injections or change in oral treatment regimen of glucosamine, chondroitin sulphate, hyaluronic acid, shark cartilage, or Vitamin E within 3 months prior to screening
Oral or parenteral corticosteroids within 3 months prior to screening
Analgesic therapy for chronic or recurrent pain conditions for indications other than OA
Immunosuppressants within 3 months of screening
Concomitant medication interfering with ketoprofen or paracetamol, according to discretion of the Investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified