Phase 3
N=343
Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID
Gastric Ulcer · Duodenal Ulcer · Rheumatoid Arthritis · Osteoarthritis · Lumbago
Bottom Line
View on ClinicalTrials.gov: NCT00542789 ↗Enrolled (actual)
343
Serious AEs
5.0%
Results posted
May 2010
Primary outcome: Primary: Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period — 167; 112 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Esomeprazole (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period |
167; 112 | — |
| SECONDARY Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment |
172; 133 | — |
| SECONDARY Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment |
168; 119 | — |
Summary
The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers
Eligibility Criteria
Inclusion Criteria
- Medical history of gastric and/or duodenal ulcer
- A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age
Exclusion Criteria
- Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
- History of esophageal, gastric or duodenal surgery
- Having severe liver disease or chronic renal disease
Data sourced from ClinicalTrials.gov (NCT00542789). 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.