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Clinical Trials/CTRI/2009/091/000297
CTRI/2009/091/000297
Completed
Phase 3

ASSESSMENT OF THE EFFICACY, SAFETY AND TOLERABILITY OF LORNOXICAM SR 16mg Vs LORNOXICAM 8mg IN ADULT PATIENTS WITH OSTEOARTHRITIS OF THE HIP AND/OR KNEE

Glenmark Pharmaceuticals Ltd.0 sites210 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Glenmark Pharmaceuticals Ltd.
Enrollment
210
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •a)Males and non\-pregnant females (with negative \&\#61538;\-human chorionic gonadotropin test). Female patients on adequate contraceptive control.
  • •b)Age: 30 to 70 years
  • •c)Clinical and radiological diagnosis of osteoarthritis of the hip and/or knee based on the American College of Rheumatology (ACR) Clinical Classification Criteria \[Appendix B].
  • •d)Patients with a baseline Patient?s Assessment of Arthritis Pain\-VAS score of \> 40mm / 4cm, and both Patient?s and Physicians? Global Assessment of Arthritis of poor or very poor.
  • •e)Patient willing to comply with study procedures and requirements.

Exclusion Criteria

  • •a)Pregnant and nursing women.
  • •b)Inflammatory arthritis, gout, pseudogout, Paget?s disease or any chronic pain syndrome that may interfere with assessment of the Index hip and/or knee.
  • •c)Symptomatic bursitis or acute joint trauma of the Index hip and/or knee.
  • •d)Conditions predisposing to gastrointestinal dysfunction (eg, history of peptic ulcer, upper gastrointestinal disease, ulcerative colitis; smoking; advancing age; concurrent corticosteroids; alcohol abuse; etc.).
  • •e)History of bleeding tendencies, cirrhosis and esophageal varices.
  • •f)History of hypersensitivity or allergy to NSAIDs, other COX\-2 inhibitors and/or sulphonamides.
  • •g)Pre\-existing asthma.
  • •h)Patients who would require concomitant therapy with drugs e.g. low dose aspirin, warfarin, anti\-epileptics, fluconazole (inhibitor of CYP 2C9/3A4\), ketoconazole (a known inhibitor of CYP 3A4\) etc.
  • •i)Immunocompromised states and patients with systemic infections.
  • •j)Patients with severe cardiac, hepatic, renal, or cerebrovascular disease, malignancy, chronic uncontrolled systemic diseases e.g., diabetes, hypertension, collagen disorders, etc. or any other serious medical illness.

Outcomes

Primary Outcomes

Not specified

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