Phase 3
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 · Lumbago
Bottom Line
View on ClinicalTrials.gov: NCT00595517 ↗Enrolled (actual)
130
Serious AEs
10.8%
Results posted
Sep 2012
Primary outcome: Primary: Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period — 125 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Esomeprazole 20 mg (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Sep 2009
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 | — |
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.
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.