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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.8,067 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

8,067

Conditions

Osteoarthritis

Interventions

CelecoxibDRUG

open-label

Any commercially available NSAID with the indication for osteoarthritisDRUG

dosing as per USPI label related to the chosen commercially marketed NSAID

Eligibility

Sex: ALLMin age: 55 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (777)

Outcomes

Primary Outcomes

Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)

CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.

Time frame: Baseline through week 24 or Early Termination (ET)

Secondary Outcomes

Percentage of Participants With Moderate to Severe Abdominal Symptoms

Abdominal symptoms coded using the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) 'Gastrointestinal Disorders' high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms"; where moderate indicated the gastrointestinal adverse event (GI AE) interfered to some extent with the participants' usual function and severe indicated the GI AE interfered significantly with participants' usual function.

Time frame: Baseline through week 24 or ET

Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs)

GI AEs defined using MedDRA SOC 'Gastrointestinal Disorders' but excluding HLGT's: Benign Neoplasms Gastrointestinal, Dental and Gingival Conditions, Oral Soft Tissue Conditions, Salivary Gland Conditions and Tongue Conditions

Time frame: Baseline through week 24 or ET

Hemoglobin (Hb) at Baseline

Time frame: Baseline

Change From Baseline Hb at Week 24

Time frame: Baseline and Week 24 or ET

Hematocrit (Hct) at Baseline

Time frame: Baseline

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Abbeville, Alabama, United States

Pfizer Investigational Site

Alexander City, Alabama, United States

Pfizer Investigational Site

Bay Minette, Alabama, United States

Pfizer Investigational Site