Clinical trial NCT01757275: High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bleeding Peptic Ulcer
Keywords: peptic ulcer bleeding
prevention of rebleeding
successful endoscopic haemostatic therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-12-28
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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.

Primary outcomes:
measure: Rate of Clinically Significant Rebleeding Within 72 Hours
timeFrame: 72 hours
Secondary outcomes:
measure: Rate of Clinically Significant Rebleeding During 7 Days
timeFrame: 7 days
measure: Rate of Clinically Significant Rebleeding During 30 Days
timeFrame: 30 days
measure: Number of Patients With Endoscopic Re-treatment Within 72 Hours
timeFrame: 72 hours
measure: Number of Patients With Endoscopic Re-treatment Within 30 Days
timeFrame: 30 days
measure: Number of Patients With Surgery Due to Rebleeding Within 72 Hours
timeFrame: within 72 hours
measure: Number of Patients With Surgery Due to Rebleeding Within 30 Days
timeFrame: within 30 days
measure: Number of Blood Units Transfused Within 72 Hours
timeFrame: within 72 hours
measure: Number of Blood Units Transfused Within 30 Days
timeFrame: within 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Ha'er bing
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Ji Nan
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xian
country: China
facility: Research Site
Study officials:
affiliation: AstraZeneca Molndal, Sweden
name: Tore Lind, MD
role: STUDY_DIRECTOR
References:
citation: 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.