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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

Page last updated: August 23, 2015

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