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.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 250
- Locations
- 6
- Primary Endpoint
- 1. Severity of pain on Visual Analogue Scale
Study Overview
Brief Summary
Osteoarthritis (OA) is a rheumatic disease in which the joint pain and stiffness can lead to significant disability and functional impairment. The knee is the most common site to be affected. Paracetamol is one of the most widely used analgesic for mild to moderate pain states. Extended release formulation of paracetamol has been shown effective and well tolerated in treating moderate to moderately sever chronic OA pain of hip and knee.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 45.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients in the age group of 45 years or older suffering from symptomatic osteoarthritis of knee for at least 3 months
- •Meeting the American College of Rheumatology (ACR) criteria for OA of the knee
- •Patients having moderate pain (VAS score 3 or greater) in disease joint when not taking analgesics
- •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
- •Patients having intraarticular injection of any drug within last 4 week
- •Patients with history of chronic alcoholism or patients who regularly consumes alcohol
- •Patients with history of major trauma or surgery in the study joint in previous 6 months
- •Radiographic evidence suggestive of other type of arthritis, fibromyalgia or collagen vascular disease
- •Patients with clinically unacceptable liver function test
- •Patients requiring hospitalization
- •Patients with compromised hepatic and renal function
- •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
- •Mentally retarded patients
- •Patients not willing to sign written informed consent
- •Patients receiving prescription analgesics, anti-inflammatory agents, myorelaxant drugs, psychotropic agents or any other drug affecting the evaluation of analgesic action
- •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.
Outcomes
Primary Outcomes
1. Severity of pain on Visual Analogue Scale
Time Frame: 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
2. Overall assessment of KOOS score for pain
Time Frame: 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
3.End of study global assessment for overall symptom relief
Time Frame: 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 Outcomes
- Adverse Events(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)
- Physician Global Evaluation of treatments(At the end of study(week 6))
- Need for Rescue analgesia(Throughout the study)