A randomised, multicentre, open-label, cross-over study to investigate the efficacy and safety of Keplat® and Flector® patch in patients with pain caused by Osteoarthritis of the knee

Sager Pharma Ltd.0 个研究点开始时间: 2013年2月8日最近更新: 2014年5月12日

试验速览

暂无简介。

•The patients meeting the following conditions will be eligible for study entry:
•1.1.Male or female out-patients aged 45 years and older;
•2.The patient has a clinical diagnosis of unilateral or bilateral Osteoarthritis of the knee;
•3.The patient takes oral NSAIDs or Paracetamol or other analgesics on a regular basis;
•4.The patient has pain intensity at least 55 mm or more on the 100mm VAS during screening visit;
•5.The patient is capable of understanding and complying with the protocol and signed (and been given a copy of) the patient information leaflet and informed consent document.
•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 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•A patient meeting the following conditions will not be eligible for study entry:
•1.1.The patient is under confinement in the hospital (i.e. in-patient status);
•2.The patient has any acute diseases at time the screening;
•3.The patient has any chronic diseases with organ insufficiency; (e.g. severe heart disease New York Health Association [NYHA] Class = 3 or lung disease;
•4.The patient has an uncontrolled diabetes and/or hypertension;
•5.The patient has known light hypersensitivity;
•6.The patient has a local skin lesion over the knee to be treated;
•7.The patient is a woman of childbearing potential without using reliable contraception;
•8.Woman who is lactating or pregnant;
•9.The patient has a known allergy or intolerability to NSAID, Paracetamol or aspirin;
•10.The patient has known allergy or intolerability to topical product including transdermal/tape product;
•11.The patient has any corticosteroid injection within a month;
•12.The patient is awaiting any surgery during the study;
•13.The patient meets any inappropriate conditions listed in the IMP’s SmPC;
•14.Participation in another clinical study at least 3 month before the screening visit;
•15.The patient planned to be enrolled is an employee of any involved study Investigator, or any involved institution, including the sponsor.

发起方

Sager Pharma Ltd.