Text Size

High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer

This study is currently recruiting participants.
Verified March 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01757275
First received: December 21, 2012
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Bleeding Peptic Ulcer
 Drug: Esomeprazole Na
Drug: Cimetidine
Drug: Esomeprazole Mg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The rate of clinically significant rebleeding of continuous i.v. infusion [ Time Frame: During 72 hours infusion phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The rate of clinically significant rebleeding [ Time Frame: Within 7 days and 30 days ] [ Designated as safety issue: No ]
  • The rate of patients had endoscopic re-treatment due to rebleeding [ Time Frame: Within 72 hours and 30 days ] [ Designated as safety issue: No ]
  • The rate of patients who had surgery due to rebleeding [ Time Frame: Within 72 hours and 30 days ] [ Designated as safety issue: No ]
  • The number of blood units transfused [ Time Frame: Within 72 hours and 30 days ] [ Designated as safety issue: No ]
  • The number of patients with AE during the continuous I.v. infusion [ Time Frame: Within 72 hours ] [ Designated as safety issue: Yes ]
  • The number of patients with AE of open oral treatment with esomeprazole Mg 40 mg [ Time Frame: Day 4 to Day 30 ] [ Designated as safety issue: Yes ]
  • Mean values of S-creatinine, S-ALP, S-AST, S-ALT, B-Bil, Hb, WBCand B-platelets [ Time Frame: At baseline, at 72 hours and at Day 30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esomeprazole Drug: Esomeprazole Na
Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous
Other Name: Nexium
Drug: Esomeprazole Mg
40 mg tablet once daily for 27 days
Other Name: Nexium
Active Comparator: Cimetidine Drug: Cimetidine
Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, teophyllin, lidocaine, nifedepine.
  • Chemotherapy or radiation therapies within 2 weeks prior to randomisation or planned during the course of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757275

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com

Locations
China, Chongqing
Research Site Recruiting
Chongqing, Chongqing, China
China, Shanghai
Research Site Recruiting
Shanghai, Shanghai, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Tore Lind, MD AstraZeneca Molndal, Sweden
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01757275     History of Changes
Other Study ID Numbers: D961DC00007
Study First Received: December 21, 2012
Last Updated: March 12, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
peptic ulcer bleeding
prevention of rebleeding
successful endoscopic haemostatic therapy

Additional relevant MeSH terms:
Peptic Ulcer
Peptic Ulcer Hemorrhage
Hemorrhage
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Cimetidine
 Omeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013