Pain caused by Osteoarthritis of the knee.
Conditions
Interventions
Trade Name: Keplat
Product Name: Keplat
Pharmaceutical Form: Transdermal patch
Trade Name: Flector
Product Name: Flector
Pharmaceutical Form: Transdermal patch
Sponsors
Sager Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to compare effectiveness of Keplat and Flector patches in the treatment of osteoarthritis of the knee. Following evaluations are made: - The pain VAS score of target knee - The tenderness of the knee - Swelling of the knee - Amount of paracetamol tablets - The Patient’s Global assessment - Investigator’s Global Assessment ;Secondary Objective: Secondary objectives of the trial is to compare tolerability, adhesion and safety of Keplat and Flector patches in the treatment of osteoarthritis of the knee. The following evaluations are made as secondary objectives: - Patch adhesion - Patch elasticity - Dermal irritancy - Safety;Primary end point(s): The Primary endpoint of the trial is the effectiveness of Keplat and Flector patches in the treatment of pain caused by osteoarthritis of the knee. Following evaluation's result will be analysed as main end-points: - The change in pain of VAS score of target knee; - The change in tenderness of the target knee; - The change in swelling of the target knee; - Change in amount of paracetamol tablets; - The Patient’s Global Assessment. - The Investigator's Global assessment;Timepoint(s) of evaluation of this end point: All visits: use of patient diary, where the amount of oral paracetamols per day will be completed by the patients; 100 mm VAS will be completed by the patient to indicate pain intensity; tenderness and swelling of the knee will be investigated. Patient and investigator global assessment will be collected on Day15 and Day29. Patient’s visit plan: - Pre-treatment:Visit 1 – Day 1: start of wash-out period, only Paracetamol intake is permitted - Randomisation visit:Visit 2 – Day 7: randomisation to the 1st treatment arm – treatment start - Visit 3 – Day 15: start of wash-out, only Paracetamol intake is permitted - Visit 4 – Day 22: 2nd treatment starts - Visit 5 – Day 29: end of treatment period - Visit 6 – Day 36-Day 43: telephone contact–Follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points of the trial is adhesiveness, tolerability and safety of Keplat and Flector patches in the treatment of pain caused by osteoarthritis of the knee. The following evaluation's result will be analysed as secondary end-points: - Patch adhesion; - Patch elasticity; - Dermal irritancy; - Safety.;Timepoint(s) of evaluation of this end point: On Day 15 and Day 29: use of patient' diary where the adhesion of patches will be evaluated by the patient. On Day 15 and Day 29: elasticity of the patches will be evaluated by the patient during the visits. Dermal irritacy will be assessed by the investigator during Day 7, Day 15, Day 22 and Day 29. Vital signs (blood prsseure and heart rate) will be measured on Day1, Day 15 and day 29. Adverse events will be monitored and collected during all visits. | — |
Countries
Hungary
Contacts
Public ContactClinical Trial Operation Manager
CPS Cortex Ltd.
Outcome results
None listed