Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
- Conditions
- OsteoarthritisArthritis, Rheumatoid
- Interventions
- Registration Number
- NCT00141102
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4484
- Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management
- Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit
- Active GD ulceration or GD ulceration within 90 days of the screening visit.
- Concomitant use of low dose aspirin
- Previous MI, stroke or significant vascular disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Diclofenac + Omeprazole - A Celecoxib -
- Primary Outcome Measures
Name Time Method Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) 6 month treatment duration CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin at Month 6/ET Month 6/ET Number of Subjects Withdrawn Due to GI Adverse Events (AEs) 6 month treatment duration GI AEs were defined using MedDRA SOC "Gastrointestinal Disorders" but excluding the following HLGTs: Benign Neoplasms Gastrointestinal; Dental and Gingival Conditions; Oral Soft Tissue Conditions; Salivary Gland Conditions; and Tongue Conditions.
Change From Baseline in Ferretin to Month 6/ET Month 6/ET Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET Month 6/ET Change From Baseline in Iron Binding Capacity to Month 6/ET Month 6/ET Change From Baseline in C-Reactive Protein to Month 6/ET Month 6/ET Number of Subjects With SUs 6 month treatment duration Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.
Number of Subjects With CSULGIEs by History of GD Ulceration 6 month treatment duration CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.
Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin 6 month treatment duration A clinically significant decrease from baseline was defined as a fall in hematocrit \> = 10 percentage points and/or hemoglobin \> = 2 g/dL.
Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs) 6 month treatment duration CSULGIE=any of the following: GD hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.
Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET) Month 6/Early Termination (ET) Subjects rated response to question: "Considering all the ways the osteoarthritis or rheumatoid arthritis affects you, how are you doing today?" using a 1 to 5 grading scale where 1=very good and 5=very poor.
Change From Baseline in Hematocrit at Month 6/ET Month 6/ET Number of Subjects With Moderate to Severe Abdominal Symptoms 6 month treatment duration Abdominal symptoms were defined by the Medical Dictionary for Regulatory Activities MedDRA System Organ Class (SOC) 'Gastrointestinal Disorders' and keeping high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms".
Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN) 6 month treatment duration GGT ULN was 49 international units (IU)/liter (L) for females and 61 IU/L for males, AST ULN was 37 IU/L for females and 39 IU/L for males, and ALT ULN was 43 IU/L for females and 45 IU/L for males.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Wansford, United Kingdom