Clinical study to investigate the efficacy and safety of Keplat and Flector patches in patients having pain because of arthritis of knee.

Conditions: Pain caused by Osteoarthritis of the knee.
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-000334-36-HU

Lead Sponsor: Sager Pharma Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.