Comparing Two Doses of IV Esomeprazole After Successful E... | NCT04407832

Studies
Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy

NCT04407832

Sponsor

Changhua Christian Hospital

Status

Withdrawn

Last Update Posted

May 29, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Peptic Ulcer Bleeding

Interventions

heat probe or hemoclip
heat probe or hemoclip

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Jul 2013Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Aug 4, 2011

First Submission Date that Met QC Criteria

May 27, 2020

First Posted Date

May 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2020

Last Update Posted Date

May 29, 2020Actual

Name	Class
Taipei Medical University Hospital	OTHER
Dalin Tzu Chi General Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
low dose PPI	Active Comparator	40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months	Device: heat probe or hemoclip
high dose PPI	Active Comparator	40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months	Device: heat probe or hemoclip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
heat probe or hemoclip	Device	for hemostasis	low dose PPI	Olympus co.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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,

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hwai-jeng Lin, M.D.	Taipei Medical University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Gastroenterology, TMUH		Taipei		110	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D010438	Peptic Ulcer Hemorrhage

Ancestor Terms

ID	Term
D006471	Gastrointestinal Hemorrhage
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage

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Browse Branches

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