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WithdrawnNCT02724150Updated Jul 10, 2018

Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding

A Phase 4 interventional study of Omeprazole High dose and Omeprazole Low dose in Gastroduodenal Ulcer, Marginal Ulcer and Peptic Ulcer Hemorrhage, sponsored by Damascus Hospital. Withdrawn at 1 site in Syrian Arab Republic. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-07-10.

Sponsored by Damascus Hospital · Phase 4, Interventional, and Treatment

Why this study was withdrawn
No participants enrolled
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low in the management of acute peptic ulcer bleeding

Read the detailed description

Evaluate the efficacy of Two different regimens of proton pump inhibitors in the management of acute peptic ulcer bleeding First: loading dose 80 mg then 8mg/h iv continuous infusion for 3 days Second Loading dose 80 mg the 40 mg every 12 h for 3 days

02

Conditions studied

  • Gastroduodenal Ulcer
  • Marginal Ulcer
  • Peptic Ulcer Hemorrhage

Keywords

  • Gastroduodenal Ulcer
  • Marginal Ulcer
  • Peptic Ulcer Hemorrhage
  • Peptic Ulcer
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

Damascus Hospital is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • High risk ulcers defined according to the Forrest classification With respect to high-risk stigmata,
  • active bleeding was defined as a continuous blood spurting (Forrest IA)
  • oozing (Forrest IB) from the ulcer base.
  • A non-bleeding visible vessel at endoscopy was defined as a discrete protuberance at the ulcer base(Forrest IIA).
  • An adherent clot was one that was resistant to forceful irrigation or suction (Forrest IIB).

Exclusion criteria

Exclusion Criteria:

  • ulcer was malignant
  • non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear....
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Omeprazole High dose

    Omeprazole 80 mg loading dose,then 8mg/h IV continuous infusion for 3 days

    Drug: Omeprazole High dose

  • Experimental
    Omeprazole Low Dose

    Omeprazole 80 mg loading dose IV then 40 mg two times per day IV for 3 days

    Drug: Omeprazole Low dose

Interventions

  • DrugOmeprazole High dose

    High regimen of Proton Pump Inhibitors in treatment of bleeding ulcer 80 mg loading dose then 8 mg/h iv for 3 days

  • DrugOmeprazole Low dose

    low regimen of Proton Pump Inhibitors in treatment bleeding ulcer 80 mg loading dose then 40 mg two times per day for 3 days

06

What researchers measure

Primary outcomes

  1. Mortality

    Time frame: 1 month

Secondary outcomes

  1. Rebleeding

    recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment

    Time frame: one month

  2. Surgery

    need for surgery

    Time frame: one month

  3. Length of hospital stay

    Time frame: one month

  4. Blood transfusions

    number of transfusion blood unites during admission

    Time frame: one month

07

Study locations

1 site
  • Damascus Hospital
    Damascus, +963, Syrian Arab Republic
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02724150
Lead sponsor
Damascus Hospital
Responsible party
Sponsor
First posted
Mar 31, 2016
Start date
Dec 1, 2017
Primary completion
Feb 2021 (estimated)
Completion
Jul 2021 (estimated)
Last update
Jul 10, 2018

Study contacts

Marouf Alhalabi, MD
principal investigator · Damascus Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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