Phase 3
N=764
A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer
Gastrointestinal Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT00251979 ↗Enrolled (actual)
764
Serious AEs
—
Results posted
Jun 2011
Primary outcome: Primary: Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo — 22; 40 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Esomeprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo |
22; 40 | — |
| SECONDARY Clinically Significant Rebleeding Within 7 Days |
27; 50 | — |
| SECONDARY Clinically Significant Rebleeding Within 30 Days |
29; 53 | — |
| SECONDARY Death Within 72 Hours |
1; 0 | — |
| SECONDARY Death Within 30 Days |
3; 8 | — |
| SECONDARY Death Related to Rebleeding Within 30 Days as Judged by the EpC |
2; 3 | — |
| SECONDARY Requirement for Surgery Within 72 Hours |
5; 9 | — |
| SECONDARY Requirement for Surgery Within 30 Days |
10; 21 | — |
| SECONDARY Requirement for Endoscopic Re-treatment Within 72 Hours |
16; 32 | — |
| SECONDARY Requirement for Endoscopic Re-treatment Within 30 Days |
24; 45 | — |
| SECONDARY Number of Blood Units Transfused Within 72 Hours |
492; 738 | — |
| SECONDARY Number of Blood Units Transfused Within 30 Days |
589; 935 | — |
| SECONDARY Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period |
284; 500 | — |
Summary
This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.
Eligibility Criteria
Inclusion Criteria
- Signs of a bleeding in the stomach
- One endoscopically confirmed bleeding ulcer in the stomach or duodenum
Exclusion Criteria
- Malignancy or other advanced disease.
- Major cardiovascular event.
- Severe hepatic disease
Data sourced from ClinicalTrials.gov (NCT00251979). 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.