High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bleeding Peptic Ulcer
Intervention: Esomeprazole Na (Drug); Cimetidine (Drug); Esomeprazole Mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Tore Lind, MD, Study Director, Affiliation: AstraZeneca Molndal, Sweden
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
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: The rate of clinically significant rebleeding of continuous i.v. infusion
Secondary outcome: The rate of clinically significant rebleedingThe rate of patients had endoscopic re-treatment due to rebleeding The rate of patients who had surgery due to rebleeding The number of blood units transfused The number of patients with AE during the continuous I.v. infusion The number of patients with AE of open oral treatment with esomeprazole Mg 40 mg Mean values of S-creatinine, S-ALP, S-AST, S-ALT, B-Bil, Hb, WBCand B-platelets
Detailed description:
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
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
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, Ji Nan, China
Research Site, Nanchang, China
Research Site, Nanjing, China
Research Site, Shanghai, China
Research Site, Wuhan, China
Research Site, Xian, China
Additional Information
Starting date: February 2013
Last updated: January 22, 2015
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