CClinicalTrials.gg
WithdrawnNCT04407832lowdosePPIUpdated May 29, 2020

Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy

An interventional study of heat probe or hemoclip and heat probe or hemoclip in Peptic Ulcer Bleeding, sponsored by Changhua Christian Hospital. Withdrawn at 1 site in Taiwan. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2020-05-29.

Sponsored by Changhua Christian Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Peptic Ulcer Bleeding

Keywords

  • hemostasis
  • heat probe
  • hemoclip
  • rebleeding
03

In context

Peptic Ulcer

193 studies on the registry are indexed under Peptic Ulcer; 31 are open to participants now.

Browse Peptic Ulcer studies →

Lead sponsor

Changhua Christian Hospital is the lead sponsor of 74 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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,
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Deviceheat probe or hemoclip

    for hemostasis

    Also known as: Olympus co.

  • Deviceheat probe or hemoclip

    for hemostasis

    Also known as: Olympus co.

06

What researchers measure

Primary outcomes

  1. further bleeding

    Number of participants with rebleeding within 14 days

    Time frame: 14 days

Secondary outcomes

  1. hospital stay

    hospital stay in day

    Time frame: 30 days

  2. need of blood transfusion

    number of participants need of blood transufion

    Time frame: 30 days

  3. surgical intervention

    number of participants need surgical intervention to manage bleeding

    Time frame: 30 days

  4. mortality

    number of participants death

    Time frame: 30 days

07

Study locations

1 site
  • Division of Gastroenterology, TMUH
    Taipei, 110, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04407832
Lead sponsor
Changhua Christian Hospital
Collaborators
Taipei Medical University Hospital, Dalin Tzu Chi General Hospital
Responsible party
Sponsor
First posted
May 29, 2020
Start date
Aug 2011
Primary completion
Jul 2013 (estimated)
Completion
Sep 2013 (estimated)
Last update
May 29, 2020

Study contacts

Hwai-jeng Lin, M.D.
principal investigator · Taipei Medical University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion