To determine the efficacy and safety 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.

Phase 4

Completed

• Conditions: Health Condition 1: null- Osteoarthritis (OA) of knee.

• Registration Number: CTRI/2010/091/001178
• Lead Sponsor: Troikaa Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Severity of pain on Visual Analogue Scale <br/ ><br>2. Overall assessment of KOOS score for pain <br/ ><br>3.End of study global assessment for overall symptom reliefTimepoint: 1.Baseline and At the end of 2, 4 and 6 week <br/ ><br>2.Baseline and At the end of 2, 4 and 6 week <br/ ><br>3.At the end of 6 week;1. Severity of pain on Visual Analogue Scale <br/ ><br>2. Overall assessment of KOOS score for pain <br/ ><br>3.End of study global assessment for overall symptom reliefTimepoint: 1.Baseline and At the end of 2, 4 and 6 week <br/ ><br>2.Baseline and At the end of 2, 4 and 6 week <br/ ><br>3.At the end of 6 week;1. Severity of pain on Visual Analogue Scale <br/ ><br>2. Overall assessment of KOOS score for pain <br/ ><br>3.End of study global assessment for overall symptom reliefTimepoint: 1.Baseline and At the end of 2, 4 and 6 week <br/ ><br>2.Baseline and At the end of 2, 4 and 6 week <br/ ><br>3.At the end of 6 week

Secondary Outcome Measures

Name	Time	Method
Adverse EventsTimepoint: Throughout the study;Change from baseline to final assessment in the KOOS sub-score for parameters other <br/ ><br>than pain (symptoms, stiffness, functions daily living, functions sports and recreation <br/ ><br>& 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)