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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01757275
First received: December 21, 2012
Last updated: July 30, 2014
Last verified: July 2014
  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:


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: 600
Study Start Date: February 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (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, theophylline, lidocaine, nifedipine.
  • Chemotherapy or radiation therapies within 2 weeks prior to randomisation or planned during the course of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757275

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

Locations
China
Research Site Recruiting
Beijing, China
Research Site Recruiting
Changsha, China
Research Site Recruiting
Chongqing, China
Research Site Recruiting
Guangzhou, China
Research Site Recruiting
Ha'er bing, China
Research Site Recruiting
Hangzhou, China
Research Site Recruiting
Ji Nan, China
Research Site Recruiting
Nanchang, China
Research Site Recruiting
Nanjing, China
Research Site Recruiting
Shanghai, China
Research Site Recruiting
Wuhan, China
Research Site Recruiting
Xian, 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: July 30, 2014
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:
Ulcer
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Esomeprazole
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014