Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stress Ulcer Prophylaxis
Intervention: Esomeprazole (Drug); Cimetidine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Xinyu Qin, Principal Investigator, Affiliation: Professor and Chairman, Department of General Surgery,Zhongshan,Hospital, Fudan University
Overall contact:
AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: The effectiveness of esomeprazole versus cimetidine for the prevention of upper GI bleedings
Secondary outcome: The proportion of patients with any overt 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com
Research Site, Baotou, China; Recruiting
Research Site, Beijing, China; Recruiting
Research Site, Changsha, China; Recruiting
Research Site, Changsha, China; Withdrawn
Research Site, Chengdu, China; Recruiting
Research Site, Chongqing, China; Recruiting
Research Site, Fuzhou, China; Recruiting
Research Site, Guangzhou, China; Recruiting
Research Site, Guangzhou, China; Not yet recruiting
Research Site, Guilin, China; Recruiting
Research Site, Haikou, China; Recruiting
Research Site, Hangzhou, China; Not yet recruiting
Research Site, Qingdao, China; Recruiting
Research Site, Shanghai, China; Recruiting
Research Site, Shanghai, China; Withdrawn
Research Site, Shenzhen, China; Recruiting
Research Site, Tianjin, China; Recruiting
Research Site, Wulumuqi, China; Recruiting
Research Site, Xi'an, China; Recruiting
Research Site, Xian, China; Withdrawn
Research Site, Xian, China; Recruiting
Research Site, Zhanjiang, China; Recruiting
Additional Information
Starting date: July 2014
Last updated: August 17, 2015
|
