Phase 3
Completed 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
Source: ClinicalTrials.gov NCT00542789 ↗
Enrolled (actual)
343
Serious AEs
5.0%
Results posted
May 2010
Primary outcomePrimary: Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period — 167; 112 Participants
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
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 | — |
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. Informational only — not medical advice.