Phase 4
N=8,067
GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00373685 ↗Enrolled (actual)
8,067
Serious AEs
2.5%
Results posted
Nov 2011
Primary outcome: Primary: Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) — 1.3; 2.4 Percentage of participants — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Celecoxib (Drug); Any commercially available NSAID with the indication for osteoarthritis (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) |
1.3; 2.4 | 0.0003 sig |
| SECONDARY Percentage of Participants With Moderate to Severe Abdominal Symptoms |
2.3; 3.4 | 0.0035 sig |
| SECONDARY Percentage of Participants Who Withdrew Due to GI Adverse Events (AEs) |
2.8; 3.0 | 0.6140 |
| SECONDARY Hemoglobin (Hb) at Baseline |
13.6; 13.6 | — |
| SECONDARY Change From Baseline Hb at Week 24 |
-0.109; -0.241 | <0.0001 sig |
| SECONDARY Hematocrit (Hct) at Baseline |
40.8; 40.9 | — |
| SECONDARY Change From Baseline Hct at Week 24 |
-0.330; -0.716 | <0.0001 sig |
| SECONDARY Percentage of Participants With Clinically Significant Decrease in Hct and/or Hb From Baseline |
0.7; 0.9; 0.8; 1.6; 0.9; 1.5 | 0.0023 sig |
| SECONDARY Percentage of Participants Satisfied With Efficacy of Current Pain Medication Overall |
39.8; 38.0; 78.5; 69.5; 81.9; 74.6 | 0.1008 |
| SECONDARY Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Time to Pain Relief |
43.2; 43.7; 80.2; 71.6; 83.2; 77.7 | 0.6562 |
| SECONDARY Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Amount of Pain Relief |
41.4; 40.5; 77.4; 69.2; 80.5; 74.5 | 0.4074 |
| SECONDARY Percentage of Participants Satisfied With Efficacy of Current Pain Medication - Duration of Pain Relief |
37.8; 36.6; 75.4; 66.8; 77.8; 71.6 | 0.2699 |
Summary
This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00373685). 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.