Osteoarthritis of the knee joint
Conditions
Interventions
Pharmaceutical Form:
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Cutaneous use
Sponsors
IDEA AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify the dose(s) of IDEA-033 that will provide a mimumum clinically meaningful effect for the treatment of signs and symptoms associated with osteoarthritis of the knee;Secondary Objective: Comparissons of safety and efficacy of three doses of IDEA-033 to placebo. This study will also determine if there is an increase in the therapeutic effect with increasing dose of IDEA-033;Primary end point(s): Change from baseline at Week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC Pain subscale Patient global assessment of response to therapy measured on a 5 point Likert Scale at Week 12 (or end of study measurements) Change from baseline at Week 12 (or end of study measurements) on the Visual Analogue Scale of the entire WOMAC Function | — |
Countries
United Kingdom
Outcome results
None listed