EUCTR2006-006298-26-CZ进行中（未招募）不适用
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 - Safety and efficacy of two dosages of Diractin in OA
IDEA AG0 个研究点目标入组 1,320 人开始时间: 2008年5月6日最近更新:
适应症
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
- 1,320
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
- •Informed consent signed and dated
- •Age older than 45 years (if age of 18-45, radiological confirmation of
- •diagnosis of knee OA is required)
- •Subject has a primary diagnosis of Functional Class I-III OA of the knee
- •and subject meets American College of Rheumatology (ACR) clinical
- •classification criteria for osteoarthritis of the knee, defined by the following:
- •Knee pain and at least 4 of the following 6:
- •oMorning stiffness <30 minutes
- •oCrepitus on active motion
- •oBony tenderness
- •oBony enlargement
- •oNo palpable warmth of synovium
- •Patient able to identify a predominantly painful (index) knee
- •Mild to moderate pain defined by pain on walking on a flat surface of the
- •index knee defined by question 1 of the WOMAC rated = 4 and a total
- •average WOMAC pain subscale of < 7 at B1 and B2
- •If female, subject is either not of childbearing potential (defined as
- •postmenopausal for at least one year or surgically sterile [bilateral tubal
- •ligation, bilateral oophorectomy or hysterectomy]) or subject is of
- •childbearing potential and practicing one of the following methods of birth
- •ototal abstinence from sexual intercourse (minimum one complete
- •menstrual cycle before study entry),
- •oa vasectomized partner,
- •ocontraceptives (oral, parenteral, or transdermal) for three consecutive
- •months prior to investigational product administration,
- •ointrauterine device (IUD), or
- •odouble-barrier method (condoms, sponge, diaphragm or vaginal ring with
- •jellies or cream).
- •If female of childbearing potential, subject has a negative urine pregnancy
- •test at screening and B2.
- •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
- •Difference in WOMAC pain rating for question 1 or the total average pain
- •score between B1 and B2 > 2
- •Skin lesions or dermatological diseases in the treatment area
- •Extreme obesity (BMI > 37)
- •Directly or indirectly involved in the conduct and administration of this
- •study (i.e. principal investigator, sub-investigator, study co-ordinators,
- •other study staff, employees of IDEA AG, IDEA contractors and/or their
- •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
- •Morbus Meulengracht/Gilbert syndrome
- •Depressive Disorders requiring treatment with tricyclics, treatment with
- •other antidepressants must be stable for 3 months prior to screening and
- •throughout the study
- •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 omeprazole, paracetamol
- •and to ingredients of the IMP including galactose
- •Preexisting asthma bronchiale or bronchospasm after taking aspirin or
- •other NSAIDs
- •Inflammatory arthritis including rheumatoid arthritis, psoriatic arthritis,
- •gout of the index knee, pseudogout, systemic lupus erythematodes, or
- •mixed connective tissue disease
- •Symptomatic ipsilateral hip OA or predominant retropatellar knee OA
- •Coagulopathy or bleeding diathesis, or concomitant use of anticoagulants
- •including low dose aspirin
- •Ischemic heart disease requiring drug therapy
- •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 = 5 times the ULN
- •Within 3 months prior or during the study
- •oIntraarticular injections of hyaluronic acid products in the index knee
- •oArthroscopy of the index knee
- •oTricyclics
- •Within 2 months prior or during the study
- •oOral, inhaled or parenteral corticosteroids (depot steroids 6 months)
- •oChange in oral treatment regimen of glucosamine, chondroitin sulfate,
- •shark cartilage, methylensulfonylmethan (MSM), Vitamin E, diacerin or
- •nutraceuticals
- •Within 1 month prior or during the study
- •oIntraarticular injections of corticosteroids in the index knee within 1
- •months prior to screening or during the study
- 另有 7 项未显示
研究者
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