Open, self-controlled phase IV. clinical study of the Nicoflex ointment on patients with knee arthrosis - Nicoflex arthrosis study
- Conditions
- The aim of the study is to proove the efficacy of Nicoflex ointment on patients with knee arthrosis in a GCP trial. Patients are selected in ambulance. Patients involved the study are on standard therapy and Nicoflex ointment is added to the treatment. Before and the endpoint of the treatment period WOMAC index and SF-36 self questionnaire are performed. Evaluation of changes of the quality of life and those of reduction of pain are documented.
- Registration Number
- EUCTR2009-012433-30-HU
- Lead Sponsor
- Reanal Pte. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Age over 50, osteoarthrosis (ACR criteria) strength of pain > 5 of numeric scale of 10.
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
Exclusion Criteria
Infectious arthritis, gravidity or lactation, autoimmun diseases, alcohol or drug abuse, intraarticular steroid treatment, oral steroid application, allergic character.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method