NCT03163680

Brief Summary

Determining the efficacy of low dose of PPI in management acute peptic ulcer bleeding

Trial Health

87
On Track

Trial Health Score

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

Enrollment
295

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2012

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2018

Completed
Last Updated

July 10, 2018

Status Verified

July 1, 2018

Enrollment Period

6.3 years

First QC Date

May 15, 2017

Last Update Submit

July 7, 2018

Conditions

Gastroduodenal UlcerMarginal UlcerPeptic Ulcer Hemorrhage

Keywords

Gastroduodenal UlcerMarginal UlcerPeptic Ulcer HemorrhagePeptic Ulcer

Outcome Measures

Primary Outcomes (1)

  • Morality

    Determination of mortality rate from ulcer bleeding

    within 1 week

Secondary Outcomes (4)

  • Rebleeding

    within 1 week

  • need for surgery

    within 1 week

  • Length of hospital stay

    within 1 month

  • Blood transfusions

    within 1 week

Study Arms (1)

Low Dose PPI

patients with upper upper gastrointestinal bleeding were treated in low dose of proton Bump inhibitor meaning 40 mg twice daily

Drug: Omeprazole 40 MG

Interventions

Omeprazole 40 MGDRUG

Omperazole 40 mg twice daily

Low Dose PPI

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the gastrointestinal department of damascus hospital

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damascus Hospital

Damascus, +963, Syria

Location

MeSH Terms

Conditions

Peptic UlcerPeptic Ulcer Hemorrhage

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesGastrointestinal HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 23, 2017

Study Start

January 1, 2012

Primary Completion

May 1, 2018

Study Completion

June 4, 2018

Last Updated

July 10, 2018

Record last verified: 2018-07

Locations

SY(1)