MedDataX Logo

Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy

NCT ID: NCT04407832

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 (PPIļ¼‰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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peptic Ulcer Bleeding

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hemostasis heat probe hemoclip rebleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

low dose PPI

40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months

Group Type ACTIVE_COMPARATOR

heat probe or hemoclip

Intervention Type DEVICE

for hemostasis

high dose PPI

40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months

Group Type ACTIVE_COMPARATOR

heat probe or hemoclip

Intervention Type DEVICE

for hemostasis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

heat probe or hemoclip

for hemostasis

Intervention Type DEVICE

heat probe or hemoclip

for hemostasis

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Olympus co. Olympus co.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Medical University Hospital

OTHER

Sponsor Role collaborator

Dalin Tzu Chi General Hospital

OTHER

Sponsor Role collaborator

Changhua Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hwai-jeng Lin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Division of Gastroenterology, TMUH

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

lowdosePPI

Identifier Type: -

Identifier Source: org_study_id