Phase 4
N=4,484
Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
Osteoarthritis · Arthritis, Rheumatoid
Bottom Line
View on ClinicalTrials.gov: NCT00141102 ↗Enrolled (actual)
4,484
Serious AEs
2.7%
Results posted
Jun 2010
Primary outcome: Primary: Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) — 20; 81 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Celecoxib (Drug); Diclofenac + Omeprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) |
20; 81 | <0.0001 sig |
| SECONDARY Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs) |
25; 92 | <0.0001 sig |
| SECONDARY Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET) |
0.754; 0.773 | 0.4146 |
| SECONDARY Number of Subjects With SUs |
5; 11 | 0.1132 |
| SECONDARY Number of Subjects With CSULGIEs by History of GD Ulceration |
7; 13; 13; 68 | — |
| SECONDARY Number of Subjects With Moderate to Severe Abdominal Symptoms |
132; 162 | 0.0495 sig |
| SECONDARY Number of Subjects Withdrawn Due to GI Adverse Events (AEs) |
114; 167 | 0.0006 sig |
| SECONDARY Change From Baseline in Hemoglobin at Month 6/ET |
-0.017; -0.423 | <0.0001 sig |
| SECONDARY Change From Baseline in Hematocrit at Month 6/ET |
-0.306; -1.425 | <0.0001 sig |
| SECONDARY Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin |
45; 123 | <0.0001 sig |
| SECONDARY 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) |
26; 86; 8; 12; 13; 27 | <0.0001 sig |
| SECONDARY Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET |
-2.689; 7.455; -0.901; 1.490; -1.151; 5.213 | <0.0001 sig |
| SECONDARY Change From Baseline in Iron Binding Capacity to Month 6/ET |
2.517; 1.952 | 0.6795 |
| SECONDARY Change From Baseline in Ferretin to Month 6/ET |
-3.396; -1.990 | 0.5920 |
| SECONDARY Change From Baseline in C-Reactive Protein to Month 6/ET |
0.058; 0.073 | 0.6819 |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00141102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.