Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy (lowdosePPI)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Peptic Ulcer Bleeding
• Intervention / Treatment: Device: heat probe or hemoclip

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Division of Gastroenterology, TMUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: low dose PPI; 40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months	Device: heat probe or hemoclip; for hemostasis; Other Names: Olympus co.
Active Comparator: high dose PPI; 40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months	Device: heat probe or hemoclip; for hemostasis; Other Names: Olympus co.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
further bleeding	Number of participants with rebleeding within 14 days	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital stay	hospital stay in day	30 days
need of blood transfusion	number of participants need of blood transufion	30 days
surgical intervention	number of participants need surgical intervention to manage bleeding	30 days
mortality	number of participants death	30 days

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital
• Collaborators: Taipei Medical University Hospital; Dalin Tzu Chi General Hospital
• Investigators: Principal Investigator: Hwai-jeng Lin, M.D., Taipei Medical University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: August 4, 2011
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: hemostasis; rebleeding; hemoclip; heat probe
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Gastrointestinal Hemorrhage; Hemorrhage; Peptic Ulcer; Peptic Ulcer Hemorrhage
• Other Study ID Numbers: lowdosePPI