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.
Conditions
Interventions
Trade Name: Nicoflex kenocs 50g (ointment)
Product Name: Nicoflex kenocs 50g (ointment)
Pharmaceutical Form: Ointment
INN or Proposed INN: Ethyl-nicotinate
CAS Number: 614-18-6
Concentration unit: % (
Sponsors
Reanal Pte. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Infectious arthritis, gravidity or lactation, autoimmun diseases, alcohol or drug abuse, intraarticular steroid treatment, oral steroid application, allergic character.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Prove the efficacy and pain-releaving effect of Nicoflex ointment in treatment of patients with knee arthrosis. ;Secondary Objective: Evaluation of safety of administration and the changes of quality of life. ;Primary end point(s): Change of WOMAC index, change in numeric rating scale. | — |
Countries
Hungary
Outcome results
None listed