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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 rebleeding

The 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

Page last updated: August 23, 2015

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