EUCTR2005-000799-42-DE进行中（未招募）不适用
Randomised, double-blind, active-controlled, parallel-group, multicentre study comparing two slow release formulations of 100 mg diclofenac in patients with primary symptomatic osteoarthritis of the hip and/or knee - OlfenTM-100 SR Depocaps® in osteoarthritis
Mepha Ltd.0 个研究点目标入组 200 人开始时间: 2006年5月9日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent obtained.
- •Male and female Caucasian outpatients between 18 and 75 years.
- •Symptoms of primary osteoarthritis since at least 3 months.
- •Osteoarthritic knee and/or hip pain for most days of the prior month and a pain intensity at rest on a horizontal 100 mm VAS pain scale of = 50 mm at baseline in treatment/NSAID naïve OA patients or pre-treated OA patients after completion of the wash-out period.
- •Radiologically diagnosed OA (Kellgren and Lawrence Index grade II or III).
- •American Rheumatism Association (ARA) functional class I, II or III.
- •Analgesic treatment required for at least the duration of the study.
- •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
排除标准
- •Hospital in-patients or patients permanently at bed rest.
- •Pregnant and/or lactating women.
- •Childbearing potential in female patients without adequate contraceptive measures
- •OA patients with a current exacerbation of symptoms (flares) requiring additional or relevant change in concomitant treatment during the study.
- •Intra-articular corticosteroid or hyaluronic acid injections into the target joint or into other joint(s) during the previous three months.
- •Other systemic (oral or parenteral) corticosteroid administration during the previous four weeks.
- •Systemic (oral or parenteral) anticoagulants during the previous four weeks.
- •Use of NSAIDs or any analgesic treatment within 3 – 7 days – depending on the half life of previous NSAID medication prior to first study dose except paracetamol or low dose aspirin
- •Physiotherapy during the wash-out and/or treatment phase.
- •Clinical signs of or laboratory evidence for severe hepatic, renal, pulmonary, cardiac, metabolic, psychiatric, cancer (other than squamous cell of the skin) or haematologic diseases, number of leucocytes < 3.500/µl, neutropenia < 1.500/µl, thrombocytes < 100.000/µl; known positive HIV, lues, hepatitis B and/or C.
- •History of or manifest gastrointestinal ulcer or gastrointestinal bleeding; haemorrhagic diathesis.
- •Any contraindication to NSAIDs, at the discretion of the investigator.
- •History of skin reactions or hypersensitivity or allergy to NSAIDs including aspirin, diclofenac or paracetamol.
- •Known intolerance or hypersensitivity to any of the ingredients of the investigational medicinal products.
- •History of drug-induced porphyria.
- •Significant injury of the target joint - hip or knee - within last 6 months.
- •Secondary arthritis: septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget´s disease, haemophilic arthropathy, psoriasis arthritis, articular fracture, ochronosis, acromegaly, haemochromatosis, Wilson´s disease, primary osteochondromatosis, heritable disorders (e. g. hypermobility), collagen gene mutations
- •Concomitant rheumatic diseases (e.g. fibromyalgia, lupus erythematodes, mixed connective tissue disease).
- •Metabolic disorders: crystal deposition diseases (Chondrocalcinosis), alkaptonuria.
- •Osteonecrosis or aseptic necrosis.
- •Colitis ulcerosa or Morbus Crohn.
- •Use of assistive devices other than a cane (walking stick) or knee brace.
- •Alcoholism, drug dependency (defined as impaired / questionable reliability) as well as neurotic personality.
研究者
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