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

Primary Purpose

Bleeding Peptic Ulcer

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Esomeprazole Na
Cimetidine
Esomeprazole Mg
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bleeding Peptic Ulcer focused on measuring peptic ulcer bleeding, prevention of rebleeding, successful endoscopic haemostatic therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Esomeprazole

Cimetidine

Arm Description

Outcomes

Primary Outcome Measures

Rate of Clinically Significant Rebleeding Within 72 Hours
Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator.

Secondary Outcome Measures

Rate of Clinically Significant Rebleeding During 7 Days
Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator.
Rate of Clinically Significant Rebleeding During 30 Days
Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator.
Number of Patients With Endoscopic Re-treatment Within 72 Hours
Number of Patients With Endoscopic Re-treatment Within 30 Days
Number of Patients With Surgery Due to Rebleeding Within 72 Hours
Number of Patients With Surgery Due to Rebleeding Within 30 Days
Number of Blood Units Transfused Within 72 Hours
Number of Blood Units Transfused Within 30 Days

Full Information

First Posted
December 21, 2012
Last Updated
February 9, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01757275
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Peptic Ulcer
Keywords
peptic ulcer bleeding, prevention of rebleeding, successful endoscopic haemostatic therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esomeprazole
Arm Type
Experimental
Arm Title
Cimetidine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Esomeprazole Na
Other Intervention Name(s)
Nexium
Intervention Description
Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous
Intervention Type
Drug
Intervention Name(s)
Cimetidine
Intervention Description
Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours
Intervention Type
Drug
Intervention Name(s)
Esomeprazole Mg
Other Intervention Name(s)
Nexium
Intervention Description
40 mg tablet once daily for 27 days
Primary Outcome Measure Information:
Title
Rate of Clinically Significant Rebleeding Within 72 Hours
Description
Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Rate of Clinically Significant Rebleeding During 7 Days
Description
Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator.
Time Frame
7 days
Title
Rate of Clinically Significant Rebleeding During 30 Days
Description
Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator.
Time Frame
30 days
Title
Number of Patients With Endoscopic Re-treatment Within 72 Hours
Time Frame
72 hours
Title
Number of Patients With Endoscopic Re-treatment Within 30 Days
Time Frame
30 days
Title
Number of Patients With Surgery Due to Rebleeding Within 72 Hours
Time Frame
within 72 hours
Title
Number of Patients With Surgery Due to Rebleeding Within 30 Days
Time Frame
within 30 days
Title
Number of Blood Units Transfused Within 72 Hours
Time Frame
within 72 hours
Title
Number of Blood Units Transfused Within 30 Days
Time Frame
within 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tore Lind, MD
Organizational Affiliation
AstraZeneca Molndal, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Beijing
Country
China
Facility Name
Research Site
City
Changsha
Country
China
Facility Name
Research Site
City
Chongqing
Country
China
Facility Name
Research Site
City
Guangzhou
Country
China
Facility Name
Research Site
City
Ha'er bing
Country
China
Facility Name
Research Site
City
Hangzhou
Country
China
Facility Name
Research Site
City
Ji Nan
Country
China
Facility Name
Research Site
City
Nanchang
Country
China
Facility Name
Research Site
City
Nanjing
Country
China
Facility Name
Research Site
City
Shanghai
Country
China
Facility Name
Research Site
City
Wuhan
Country
China
Facility Name
Research Site
City
Xian
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26581750
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=690&filename=China_PUB_Study_D961DC00007_Clinical_Study_Protocol_GEL_Redacted_(approved).pdf
Description
China_PUB_Study_D961DC00007_Clinical_Study_Protocol_GEL_Redacted_(approved)

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

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