Health Condition 1: null- Osetoarthrites of Knee
Conditions
Interventions
Intervention1: Paracetamol 500 mg &
Ibuprofen 150 mg: Paracetamol 500 mg &
Ibuprofen 150 mg 2 tablets every 6 hours orally with water
Control Intervention1: paracetamol 500mg
ibuprofen 300 mg
ibuprofen 150 mg: Paracetamol 500mg, 2 tablets every 6 hours orally with water
I
Sponsors
AFT Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1.Provide written informed consent before initiation of any study-related procedures 2.Symptoms of OA of the knee for at least 6 months which has required analgesic medication 3.Be between 45-80 years of age inclusive on the day of consent 4.Physician opinion that long term medication for treatment of painful OA is indicated 5.Painful osteoarthritis of the study knee determined by the investigator with an average pain score of at least 40 and no more than 80mm on the WOMAC VAS pain scales following a 3-7 day washout of existing analgesics
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if any of the following exclusion criteria apply prior to randomization: Study contra-indications 1. Symptoms of OA of both the knee and the hip that require treatment 2. Weight less than 50kg 3. Rheumatoid arthritis or other inflammatory arthritis 4. Gout or recurrent episodes of pseudogout 5. Paget?s disease 6. Articular fracture 7. Onchronosis 8. Acromegaly 9. Haemochromatosis 10. Wilson?s Disease 11. Primary Osteochondromatosis 12. Heritable disorders (e.g. hypermobility) 13. Oral or parenteral corticosteroids within 2 months or intra-articular hyaluronic acid within 9 months 14. Having taken any single dose of an NSAID or paracetamol within 12 hours prior to first dose of study drug 15. Known to be pregnant or possibly pregnant (serum -HCG test positive) 16. Woman of child bearing age who, in the opinion of the investigator, are not using reliable contraception 17. Alcohol intake 18. Suffering from a neurological disorder relating to pain perception 19. In the opinion of the investigator, unable to understand the visual analogue pain score 20. Currently, or in last 30 days, participating in a clinical trial involving another study drug 21. Suffering from any other diseases or condition which, in the opinion of the investigator, means that it would not be in the patient?s best interests to participate in this study NSAID and/or paracetamol contra-indications 1. Hypersensitivity to aspirin or other NSAID 2. Hypersensitivity to paracetamol 3. Severe known haemopoetic, renal or hepatic disease, immunosuppressed 4. History of gastric ulceration, indigestion, stomach pain or GI bleeding or bleeding disorders 5. Currently suffering from dehydration through diarrhoea and/or vomiting 6. History of severe asthma defined as previous steroid treatment or hospital admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the analgesic efficacy and clinical safety of Maxigesic (paracetamol 500mg + ibuprofen 150 mg) with the other 3 treatment groups (paracetamol; low dose ibuprofen; high dose ibuprofen) in patients who have painful osteoarthritis of the knee.Timepoint: 4 weeks of treatment for the 4 treatment groups | — |
Secondary
| Measure | Time frame |
|---|---|
| to assess the feasibility of conducting a phase III OA study and derive data for a power calculation to estimate the sample size required for such a study.Timepoint: 4 weeks of treatment during the double blind phase with the 4 treatment groups | — |
Countries
India
Contacts
Public ContactMr Piyush Pandya
Outcome results
None listed