At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 395 enrolled
Drug / intervention
Esomeprazole 20 mgdrug
Likely dose
Esomeprazole 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use
In Brief
A Phase 3 clinical trial evaluating Esomeprazole 20 mg for Gastric Ulcer and 4 related conditions. Completed, enrolled 395 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedJan 2008
Primary CompletionSep 2009
TodayJul 2026
First PostedJan 16, 2008
Enrollment StartOct 1, 2007
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.5 years ago
Interventions
Esomeprazole 20 mgdrug
Esomeprazole 20 mg once daily