Phase 3
N=222
High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer
Bleeding Peptic Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT01757275 ↗Enrolled (actual)
222
Serious AEs
4.7%
Results posted
Mar 2016
Primary outcome: Primary: Rate of Clinically Significant Rebleeding Within 72 Hours — 107; 101; 1; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Esomeprazole Na (Drug); Cimetidine (Drug); Esomeprazole Mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Clinically Significant Rebleeding Within 72 Hours |
107; 101; 1; 6 | — |
| SECONDARY Rate of Clinically Significant Rebleeding During 7 Days |
105; 101; 3; 6 | — |
| SECONDARY Rate of Clinically Significant Rebleeding During 30 Days |
105; 101; 3; 6 | — |
| SECONDARY Number of Patients With Endoscopic Re-treatment Within 72 Hours |
108; 106; 0; 1 | — |
| SECONDARY Number of Patients With Endoscopic Re-treatment Within 30 Days |
106; 106; 2; 1 | — |
| SECONDARY Number of Patients With Surgery Due to Rebleeding Within 72 Hours |
108; 107; 0; 0 | — |
| SECONDARY Number of Patients With Surgery Due to Rebleeding Within 30 Days |
108; 106; 0; 1 | — |
| SECONDARY Number of Blood Units Transfused Within 72 Hours |
14; 21 | — |
| SECONDARY Number of Blood Units Transfused Within 30 Days |
18; 21 | — |
Summary
To describe the rate of clinically significant rebleeding during 72 hours continuous i.v. infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures.
- Female or male aged =18 years and =70 years.
- Acute upper gastrointestinal bleeding (haematemesis, melaena or haematochezia) or such signs within the last 24 hours as judged by the investigator.
- One endoscopically confirmed bleeding gastric or duodenal peptic ulcer, at least 5 mm in diameter, classified as Forrest Ia, Ib, IIa, or IIb. Photo documentation of the source of bleeding should be provided.
- Successful haemostasis (which is considered to have been established if bleeding has stopped and, if applicable, formerly bleeding vessels are flattened or cavitated) achieved by endoscopic treatment and confirmed by site staff.
Exclusion Criteria
- Endoscopic suspicion of gastric malignancy or juxta pyloric stenosis as judged by the investigator.
- Sign of multi PUB or concomitant other gastro bleeding from esophageal varices, reflux esophagitis, gastritis, Mallory Weiss rifts, ulcus simplex, Dieulafoy's lesion, colon, small bowel, or ulcer distal to the stom in Billroth-resected patients.
- Need for treatment during the first 7 days of the study with NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, acetyl salicylic acid (ASA) (including low dose) or clopidogrel.
- Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.
- Chemotherapy or radiation therapies within 2 weeks prior to randomisation or planned during the course of the study.
Data sourced from ClinicalTrials.gov (NCT01757275). 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.