GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS) (GI-REASONS)

Viatris

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Drug: Celecoxib; Drug: Any commercially available NSAID with the indication for osteoarthritis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00373685

A3191331

Details and patient eligibility

About

This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.

Enrollment: 8,067 patients

Sex: All

Ages: 55 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients of at least 55 years of age with a clinical diagnosis of OA who are expected to require daily prescription anti-inflammatory analgesic therapy for arthritis symptom management and for whom either celecoxib or a nsNSAID is an appropriate treatment option.

Exclusion criteria

• GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening visit.
• Patients with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8,067 participants in 2 patient groups

Celecoxib

Experimental group

Description:

dosing as per USPI label

Treatment:

Drug: Celecoxib

NSAIDs

Active Comparator group

Treatment:

Drug: Any commercially available NSAID with the indication for osteoarthritis