Phase 3
Completed N=130
Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer
Gastric Ulcer · Duodenal Ulcer · Rheumatoid Arthritis · Osteoarthritis
Source: ClinicalTrials.gov NCT00595517 ↗
Enrolled (actual)
130
Serious AEs
10.8%
Results posted
Sep 2012
Primary outcomePrimary: Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period — 125 Participants
Summary
The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period |
125 | — |
| SECONDARY Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment |
130 | — |
| SECONDARY Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment |
127 | — |
| SECONDARY Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment |
126 | — |
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 (NCT00595517). 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.