High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer
A Multi-center, Randomised, Double-blind, Parallel-group Phase III Study to Assess High Dose Esomeprazole Na i.v. Treatment (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour Administered for 72 Hours) for Prevention of Rebleeding
1 other identifier
interventional
239
1 country
12
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2013
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2012
CompletedFirst Posted
Study publicly available on registry
December 28, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
March 8, 2016
CompletedMarch 8, 2016
February 1, 2016
1.8 years
December 21, 2012
December 16, 2015
February 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Clinically Significant Rebleeding Within 72 Hours
Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb \>20g/L (or Hct \>6%) during 24 hours or an increase in Hb \<10g/L (or Hct \<3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (\>200 ml) of fresh blood as estimated by the investigator.
72 hours
Secondary Outcomes (8)
Rate of Clinically Significant Rebleeding During 7 Days
7 days
Rate of Clinically Significant Rebleeding During 30 Days
30 days
Number of Patients With Endoscopic Re-treatment Within 72 Hours
72 hours
Number of Patients With Endoscopic Re-treatment Within 30 Days
30 days
Number of Patients With Surgery Due to Rebleeding Within 72 Hours
within 72 hours
- +3 more secondary outcomes
Study Arms (2)
Esomeprazole
EXPERIMENTALCimetidine
ACTIVE COMPARATORInterventions
Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous
Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (12)
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Chongqing, China
Research Site
Guangzhou, China
Research Site
Ha'er Bing, China
Research Site
Hangzhou, China
Research Site
Jinan, China
Research Site
Nanchang, China
Research Site
Nanjing, China
Research Site
Shanghai, China
Research Site
Wuhan, China
Research Site
Xi'an, China
Related Publications (1)
Bai Y, Chen DF, Wang RQ, Chen YX, Shi RH, Tian DA, Chen H, Eklund S, Li ZS; Chinese Peptic Ulcer Bleeding Research Group. Intravenous Esomeprazole for Prevention of Peptic Ulcer Rebleeding: A Randomized Trial in Chinese Patients. Adv Ther. 2015 Nov;32(11):1160-76. doi: 10.1007/s12325-015-0265-6. Epub 2015 Nov 18.
PMID: 26581750DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No hypothesis testing was performed in this study and, as such, no formal statistical comparisons were made. Two patients who were initially randomised to receive cimetidine treatment actually received esomeprazole treatment.
Results Point of Contact
- Title
- Huifang Chen
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Tore Lind, MD
AstraZeneca Molndal, Sweden
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2012
First Posted
December 28, 2012
Study Start
February 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
March 8, 2016
Results First Posted
March 8, 2016
Record last verified: 2016-02