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Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients (SUP)

Primary Purpose

Stress Ulcer Prophylaxis

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

About this trial

This is an interventional prevention trial for Stress Ulcer Prophylaxis focused on measuring SUP, Upper GI bleeding, Seriously ill patients

Eligibility Criteria

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

Inclusion Criteria:

  1. Critically ill patients
  2. Requirement for mechanical ventilation
  3. At least one major risk factor for stress ulcer related bleeding

Exclusion Criteria:

  1. History of gastric or oesophageal surgery
  2. Evidence of active GI bleeding
  3. Advanced renal disease
  4. Treatment with any Proton Pump Inhibitors

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Esomeprazole active treatment

Cimetidine active treatment

Arm Description

iv esomeprazole 30 min intermittent infusions given for maximum 14 days

iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days

Outcomes

Primary Outcome Measures

The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase
Criteria for a clinically significant upper GI bleeding as: Bright red blood per NG or OG tube that did not clear after NG or OG tube adjustment and 5 to 10 minutes of at least 100 ml lavage with room temperature normal saline-or, Persistent gastroccult- positive coffee ground material During IMP treatment Day 1-2: Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline. During IMP treatment Day 3-14: Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline.

Secondary Outcome Measures

Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase
Criteria for a significant upper GI bleeding as described in primary outcome measure or, Criteria for a non-significant upper GI bleeding as: Bright red blood per NG or OG tube that clear after NG or OG tube adjustment and 5 to 10 minutes of lavage with room temperature normal saline or, Persistent gastroccult- positive coffee ground material During IMP treatment Day 1-2: Persistent gastroccult - positive coffee ground material for at less than eight consecutive hours or that clear with at least 100 ml of lavage with room temperature normal saline. During IMP treatment Day 3-14: Persistent gastroccult - positive coffee ground material in less than three consecutive gastric aspirates within 2 to 4 hours (at least 60±20 minutes apart), or that clear with at least 100 ml of lavage with room temperature normal saline or, Any clinical signs of hematemesis or melena or haematochezia judged (by the Investigator) to be from an upper GI source.

Full Information

First Posted
May 28, 2014
Last Updated
January 30, 2017
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02157376
Brief Title
Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients
Acronym
SUP
Official Title
Effect of Intravenous Esomeprazole Versus Cimetidine in Prevention of Stress Ulcer Prophylaxis in Chinese Seriously Ill Patients - a Randomized, Double-blind, Parallel-group Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper GI bleeding.
Detailed Description
Stress related upper Gastrointestinal (GI) bleedings are important events associated with morbidity and mortality among seriously ill patients. Data from the literature suggest that stress ulcer prevention with effective acid suppressive treatment can reduce bleeding events and is thus an important therapy in high-risk patients. Esomeprazole has the potential to reduce gastric acidity for prolonged periods of time adequate for both preventing mucosal damage and facilitating coagulation. This study is to reveal whether intravenous (iv) esomeprazole is effective in preventing upper gastrointestinal bleeding and if it is tolerated by Chinese seriously ill patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Ulcer Prophylaxis
Keywords
SUP, Upper GI bleeding, Seriously ill patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esomeprazole active treatment
Arm Type
Experimental
Arm Description
iv esomeprazole 30 min intermittent infusions given for maximum 14 days
Arm Title
Cimetidine active treatment
Arm Type
Active Comparator
Arm Description
iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
iv esomeprazole 30 min intermittent infusions given for maximum 14 days
Intervention Type
Drug
Intervention Name(s)
Cimetidine
Other Intervention Name(s)
Tagamet
Intervention Description
iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days
Primary Outcome Measure Information:
Title
The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase
Description
Criteria for a clinically significant upper GI bleeding as: Bright red blood per NG or OG tube that did not clear after NG or OG tube adjustment and 5 to 10 minutes of at least 100 ml lavage with room temperature normal saline-or, Persistent gastroccult- positive coffee ground material During IMP treatment Day 1-2: Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline. During IMP treatment Day 3-14: Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline.
Time Frame
1-14 days
Secondary Outcome Measure Information:
Title
Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase
Description
Criteria for a significant upper GI bleeding as described in primary outcome measure or, Criteria for a non-significant upper GI bleeding as: Bright red blood per NG or OG tube that clear after NG or OG tube adjustment and 5 to 10 minutes of lavage with room temperature normal saline or, Persistent gastroccult- positive coffee ground material During IMP treatment Day 1-2: Persistent gastroccult - positive coffee ground material for at less than eight consecutive hours or that clear with at least 100 ml of lavage with room temperature normal saline. During IMP treatment Day 3-14: Persistent gastroccult - positive coffee ground material in less than three consecutive gastric aspirates within 2 to 4 hours (at least 60±20 minutes apart), or that clear with at least 100 ml of lavage with room temperature normal saline or, Any clinical signs of hematemesis or melena or haematochezia judged (by the Investigator) to be from an upper GI source.
Time Frame
1-14 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: Critically ill patients Requirement for mechanical ventilation At least one major risk factor for stress ulcer related bleeding Exclusion Criteria: History of gastric or oesophageal surgery Evidence of active GI bleeding Advanced renal disease Treatment with any Proton Pump Inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinyu Qin
Organizational Affiliation
Professor and Chairman, Department of General Surgery,Zhongshan,Hospital, Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Baotou
Country
China
Facility Name
Research Site
City
Changsha
Country
China
Facility Name
Research Site
City
Chengdu
Country
China
Facility Name
Research Site
City
Chongqing
Country
China
Facility Name
Research Site
City
Fuzhou
Country
China
Facility Name
Research Site
City
Guangzhou
Country
China
Facility Name
Research Site
City
Guilin
Country
China
Facility Name
Research Site
City
Haikou
Country
China
Facility Name
Research Site
City
Qingdao
Country
China
Facility Name
Research Site
City
Shanghai
Country
China
Facility Name
Research Site
City
Shenzhen
Country
China
Facility Name
Research Site
City
Tianjin
Country
China
Facility Name
Research Site
City
Wulumuqi
Country
China
Facility Name
Research Site
City
Xi'an
Country
China
Facility Name
Research Site
City
Xian
Country
China
Facility Name
Research Site
City
Zhanjiang
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29638148
Citation
Lou W, Xia Y, Xiang P, Zhang L, Yu X, Lim S, Xu M, Zhao L, Rydholm H, Traxler B, Qin X. Prevention of upper gastrointestinal bleeding in critically ill Chinese patients: a randomized, double-blind study evaluating esomeprazole and cimetidine. Curr Med Res Opin. 2018 Aug;34(8):1449-1455. doi: 10.1080/03007995.2018.1464132. Epub 2018 Apr 20.
Results Reference
derived

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Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

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