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

January 30, 2017 updated by: AstraZeneca

Effect of Intravenous Esomeprazole Versus Cimetidine in Prevention of Stress Ulcer Prophylaxis in Chinese Seriously Ill Patients - a Randomized, Double-blind, Parallel-group Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

343

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Baotou, China
        • Research Site
      • Changsha, China
        • Research Site
      • Chengdu, China
        • Research Site
      • Chongqing, China
        • Research Site
      • Fuzhou, China
        • Research Site
      • Guangzhou, China
        • Research Site
      • Guilin, China
        • Research Site
      • Haikou, China
        • Research Site
      • Qingdao, China
        • Research Site
      • Shanghai, China
        • Research Site
      • Shenzhen, China
        • Research Site
      • Tianjin, China
        • Research Site
      • Wulumuqi, China
        • Research Site
      • Xi'an, China
        • Research Site
      • Xian, China
        • Research Site
      • Zhanjiang, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Esomeprazole active treatment
iv esomeprazole 30 min intermittent infusions given for maximum 14 days
Drug: Esomeprazole
iv esomeprazole 30 min intermittent infusions given for maximum 14 days
Other Names:
  • Nexium
Active Comparator: Cimetidine active treatment
iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days
Drug: Cimetidine
iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days
Other Names:
  • Tagamet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase
Time Frame: 1-14 days

Criteria for a clinically significant upper GI bleeding as:

  1. 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,
  2. 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.
1-14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase
Time Frame: 1-14 days

Criteria for a significant upper GI bleeding as described in primary outcome measure or,

Criteria for a non-significant upper GI bleeding as:

  1. 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,

  2. 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,

  3. Any clinical signs of hematemesis or melena or haematochezia judged (by the Investigator) to be from an upper GI source.
1-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Xinyu Qin, Professor and Chairman, Department of General Surgery,Zhongshan,Hospital, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D961OC00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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