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

IDEA AG0 个研究点目标入组 700 人开始时间: 2005年6月13日最近更新: 2020年7月27日

试验速览

暂无简介。

•Informed consent
•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

•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

发起方

IDEA AG