Effectiveness And Safety Of Polmacoxib Capsule In The Management of Hip/Knee Osteoarthritis.

Phase 4

Recruiting

• Conditions: Health Condition 1: M169- Osteoarthritis of hip, unspecified

• Registration Number: CTRI/2024/06/069581
• Lead Sponsor: Abbott Healthcare Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male and female patients in the age group of 20 to 70 years, with a clinical diagnosis of knee or hip osteoarthritis as per the discretion of investigators.

2.Patients having chronic pain for 3 months or more due to osteoarthritis.

3. The baseline (predose) mean WOMAC pain score in the index joint is between 4 and 8.

4. Patients willing to provide written informed consent and comply with study procedures

Exclusion Criteria

1. Use of any analgesics except the study medication or acetaminophen 24 hours before study drug administration and during the study.

2. Use of anticoagulants within 2 weeks before study enrollment.

3. Use of corticosteroids, herbal medicines, traditional ayurvedic medicines, nutraceuticals, glucosamine, and/or chondroitin sulfate within 3 months before study enrollment.

4. Requirement for knee or hip arthroplasty within 2 months of screening or anticipating any need for a surgical procedure on the index joint during the study.

5. Hypersensitivity or allergy to NSAID.

6. Pregnant and lactating women.

7. History of nasal polyps, bronchospasm, urticaria, or anaphylactic shock; history of New York Heart Association stage II-IV congestive heart failure, ischemic heart disease, uncontrolled hypertension, peripheral arterial disease, and/or cerebrovascular disease; pregnancy, breast-feeding, or expecting conception within the duration of the study; active ulcer, GI bleeding, ulcerative colitis, or severe renal, hepatic, or coagulant disorder within 6 months before randomization; ongoing chronic symptoms or psychiatric disorders preventing compliance with study procedures, except for subjects who were physically healthy and had been receiving the specified allowed drugs for =3 months; use of corticosteroids, intra-articular steroids or hyaluronic acid injections within 1 month of screening; chemotherapy within 5 years.

8. Patients with any other conditions or diseases that the investigator considers inappropriate to enter the study as per prescribing information

Study & Design

• Study Type: PMS
• Study Design: Not specified