Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients
SUP
Effect of Intravenous Esomeprazole Versus Cimetidine in Prevention of Stress Ulcer Prophylaxis in Chinese Seriously Ill Patients - a Randomized, Double-blind, Parallel-group Study
1 other identifier
interventional
343
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2014
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2014
CompletedFirst Posted
Study publicly available on registry
June 6, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
January 23, 2017
CompletedMarch 10, 2017
January 1, 2017
1.6 years
May 28, 2014
November 28, 2016
January 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase
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 Outcomes (1)
Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase
1-14 days
Study Arms (2)
Esomeprazole active treatment
EXPERIMENTALiv esomeprazole 30 min intermittent infusions given for maximum 14 days
Cimetidine active treatment
ACTIVE COMPARATORiv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days
Interventions
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
Eligibility Criteria
You may qualify if:
- Critically ill patients
- Requirement for mechanical ventilation
- At least one major risk factor for stress ulcer related bleeding
You may not qualify if:
- History of gastric or oesophageal surgery
- Evidence of active GI bleeding
- Advanced renal disease
- Treatment with any Proton Pump Inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (15)
Research Site
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
Ürümqi, China
Research Site
Xi'an, China
Research Site
Zhanjiang, China
Related Publications (1)
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.
PMID: 29638148DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Barry Traxler
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Xinyu Qin
Professor and Chairman, Department of General Surgery,Zhongshan,Hospital, Fudan University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2014
First Posted
June 6, 2014
Study Start
July 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 10, 2017
Results First Posted
January 23, 2017
Record last verified: 2017-01