Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy

Peptic Ulcer Bleeding Clinical Trial

— lowdosePPI  

Official title:

A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04407832
• Other study ID #: lowdosePPI
• Status: Withdrawn
• Phase: N/A
• Start date: August 2011
• Est. completion date: September 2013

Study information

• Verified date: May 2020
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.

The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.

Description:

A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients receiving intravenous Proton Pump Inhibitor (PPI）and is now recommended as the first hemostatic modality for these patients. In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, including two consensus statements and two meta-analysis. To sustain a high intragastric pH, a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding. However, in one recent published metaanalysis found that low dose PPI may be as effective as high dose PPI in preventing further bleeding in high-risk patients. Therefore, one double blind study is needed clarify this puzzle.

We used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.

The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• patients with peptic ulcer bleeding with active bleeding or nonbleeding visible (initial Hb<10, shock, or coffee grounds or blood in stomach)

Exclusion Criteria:

• age >90y/o

• pregnant woman

• allergic to esomeprazole

• unwilling to enter this study

• bleeding tendency

• severe co-morbid illness, including cancer, hepatic failure, renal failure,

Related Conditions & MeSH terms

• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Bleeding
• Peptic Ulcer Hemorrhage

Intervention

Device:
• heat probe or hemoclip
for hemostasis
• heat probe or hemoclip
for hemostasis

Locations

Country	Name	City	State
Taiwan	Division of Gastroenterology, TMUH	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
Changhua Christian Hospital	Dalin Tzu Chi General Hospital, Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	further bleeding	Number of participants with rebleeding within 14 days	14 days
Secondary	hospital stay	hospital stay in day	30 days
Secondary	need of blood transfusion	number of participants need of blood transufion	30 days
Secondary	surgical intervention	number of participants need surgical intervention to manage bleeding	30 days
Secondary	mortality	number of participants death	30 days