Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

Stress Ulcer Prophylaxis Clinical Trial

— SUP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02157376
• Other study ID #: D961OC00002
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 28, 2014
• Last updated: February 24, 2016
• Start date: July 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stress Ulcer Prophylaxis
• Ulcer

Intervention

Drug:
• Esomeprazole
iv esomeprazole 30 min intermittent infusions given for maximum 14 days
• Cimetidine
iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days

Locations

Country	Name	City	State
China	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	Wulumuqi
China	Research Site	Xi'an
China	Research Site	Xian
China	Research Site	Zhanjiang

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The time to upper GI bleeding event	The time to upper GI bleeding event during the treatment period in seriously ill patients receiving esomeprazole or cimetidine will be measured.	Treatment evaluation phase is 1-14 days.	No
Primary	The effectiveness of esomeprazole versus cimetidine for the prevention of upper GI bleedings	The effectiveness of esomeprazole versus cimetidine for the prevention of upper GI bleeding in seriously ill patients by comparing the proportion of patients with upper GI bleeding will be measured.	Treatment evaluation phase is 1-14 days.	No
Secondary	The proportion of patients with any overt upper GI bleeding	The proportion of patients with any overt upper GI bleeding during the treatment period in the group of patients receiving esomeprasole vs the group of patients receiving cimetidine will be measured.	Treatment evaluation phase is 1-14 days.	No