A Clinical study of Ostofix Tablet in subjects suffering from Osteoarthritis of Knee(s)

Phase 2

Completed

• Conditions: Health Condition 1: null- Osteoarthritis of Knee

• Registration Number: CTRI/2014/02/004373
• Lead Sponsor: ARJUN HEALTHCARE

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: 36

Inclusion Criteria

•Symptoms of osteoarthritis in one or both knee joints for a minimum of six months and maximum for five years

•History of knee pain due to osteoarthritis requiring the use of NSAIDs

Acetaminophen or another analgesic agent on a regular basis greater than or equal to three days per week for at least six months before the screening visit

•OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria clinical and radiological

•Subjects may take tab paracetamol greater than or equal to 2g per day or any standard analgesic drug for breakthrough pain

•Subjects not having knee joint deformity

•Subjects signing written informed consent and ready to comply with the protocol requirements

•Subjects with pain VAS greater than 40 mm on weight bearing activities

Exclusion Criteria

•Rheumatoid arthritis, gout pseudo gout inflammatory arthritis Pagets disease of bone chronic pain syndrome fibromyalgia or another major joint disease

•History of surgery including arthroscopy or major trauma to the study joint in the previous six months before the screening visit

•Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study

•Signs of clinically important active inflammation of the study knee joint including redness warmth and or a large bulging effusion with the loss of normal contour at the screening and or baseline visits

•Use of systemic corticosteroids within 2 months of screening or intra-articular viscosupplementation within the past 3 months

•Use of any other investigational drug within 1 month prior to randomization

•Subjects having diabetes mellitus tuberculosis HIV Ischemic Heart Disease

•Known other major medical or surgical disease

•Pregnancy and Lactation.

•Known hypersensitivity to ingredients used in study drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified