Clinical trial NCT02157376: Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Ulcer Prophylaxis
Keywords: SUP
Upper GI bleeding
Seriously ill patients
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-06-06
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase
timeFrame: 1-14 days
Secondary outcomes:
measure: Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase
timeFrame: 1-14 days
Other outcomes:
Locations:
city: Baotou
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guilin
country: China
facility: Research Site
city: Haikou
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Wulumuqi
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Xian
country: China
facility: Research Site
city: Zhanjiang
country: China
facility: Research Site
Study officials:
affiliation: Professor and Chairman, Department of General Surgery,Zhongshan,Hospital, Fudan University
name: Xinyu Qin
role: PRINCIPAL_INVESTIGATOR
References:
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.