Health Condition 1: null- Osteoarthritis (OA) of knee.
Conditions
Interventions
Intervention1: Paracetamol Extended Release Tablet 650 mg: One Tablet twise daily for 6 weeks
Control Intervention1: Conventional Paracetamol 500 mg tablet: One tablet three times a day for 6 Weeks.
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients in the age group of 45 years or older suffering from symptomatic osteoarthritis of knee for at least 3 months 2. Meeting the American College of Rheumatology (ACR) criteria for OA of the knee 3. Patients having moderate pain (VAS score 3 or greater) in disease joint when not taking analgesics 4. Patients having a washout period of Paracetamol or NSAIDs for at least 48 hours (or longer depending on the pharmacokinetic of drug) before starting the study drug.
Exclusion criteria
Exclusion criteria: 1. Patients having intraarticular injection of any drug within last 4 week 2. Patients with history of chronic alcoholism or patients who regularly consumes alcohol 3. Patients with history of major trauma or surgery in the study joint in previous 6 months 4. Patients with history of acute inflammatory arthritis or pseudogout of the study joint 5. Radiographic evidence suggestive of other type of arthritis, fibromyalgia or collagen vascular disease 6. Patients with clinically unacceptable liver function test 7. Patients requiring hospitalization 8. Patients with compromised hepatic and renal function 9. Pregnant and lactating women 10.Women of child bearing age not practicing or not willing to use contraceptive 11.Patients with history of bronchial asthma, peptic ulceration, bronchitis or any other contraindication to study drug 12. Mentally retarded patients 13. Patients not willing to sign written informed consent 14. Patients with known hypersensitivity to NSAIDs and or related products 15. Patients receiving prescription analgesics, anti-inflammatory agents, myorelaxant drugs, psychotropic agents or any other drug affecting the evaluation of analgesic action 16. Patients who participated in any clinical trial with in 30 days before enrollment into the study 17.Patients, for any reason who are considered to be unsuitable candidates by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Severity of pain on Visual Analogue Scale 2. Overall assessment of KOOS score for pain 3.End of study global assessment for overall symptom reliefTimepoint: 1.Baseline and At the end of 2, 4 and 6 week 2.Baseline and At the end of 2, 4 and 6 week 3.At the end of 6 week;1. Severity of pain on Visual Analogue Scale 2. Overall assessment of KOOS score for pain 3.End of study global assessment for overall symptom reliefTimepoint: 1.Baseline and At the end of 2, 4 and 6 week 2.Baseline and At the end of 2, 4 and 6 week 3.At the end of 6 week;1. Severity of pain on Visual Analogue Scale 2. Overall assessment of KOOS score for pain 3.End of study global assessment for overall symptom reliefTimepoint: 1.Baseline and At the end of 2, 4 and 6 week 2.Baseline and At the end of 2, 4 and 6 week 3.At the end of 6 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse EventsTimepoint: Throughout the study;Change from baseline to final assessment in the KOOS sub-score for parameters other than pain (symptoms, stiffness, functions daily living, functions sports and recreation & QOL)Timepoint: At the end of 2 week 4 week and 6 week;Need for Rescue analgesiaTimepoint: Throughout the study;Physician Global Evaluation of treatmentsTimepoint: At the end of study(week 6) | — |
Countries
India
Contacts
Public ContactDr Sanjay Maroo
Outcome results
None listed