NCT04407832

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
6.7 years until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

1.9 years

First QC Date

August 4, 2011

Last Update Submit

May 27, 2020

Conditions

Peptic Ulcer Bleeding

Keywords

hemostasisheat probehemocliprebleeding

Outcome Measures

Primary Outcomes (1)

  • further bleeding

    Number of participants with rebleeding within 14 days

    14 days

Secondary Outcomes (4)

  • hospital stay

    30 days

  • need of blood transfusion

    30 days

  • surgical intervention

    30 days

  • mortality

    30 days

Study Arms (2)

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

heat probe or hemoclipDEVICE

for hemostasis

Also known as: Olympus co.
low dose PPI

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gastroenterology, TMUH

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal HemorrhageGastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hwai-jeng Lin, M.D.

    Taipei Medical University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2011

First Posted

May 29, 2020

Study Start

August 1, 2011

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations

TW(1)