A randomized comparative study evaluating efficacy and tolerability of Extended Release Paracetamol 650 mg tablet twice a day versus Conventional Paracetamol 500 mg tablet three times a day in the treatment of Osteoarthritis (OA) of knee.

Troikaa Pharmaceuticals Limited0 个研究点目标入组 250 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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.

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