NCT04550858

Brief Summary

the primary aim is specially in resistant cases of H.pylori and in promotion of peptic ulcer

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Status
unknown

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

First Submitted

Initial submission to the registry

August 21, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

September 5, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2021

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

12 months

First QC Date

August 21, 2020

Last Update Submit

September 9, 2020

Conditions

H.Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • Gastric ulcer healing rate in resistant cases of H. pylori resistant cases of h.pylori

    healing rate of gastric ulcer defined as complete disappearance of the white coating

    8 weeks

Secondary Outcomes (1)

  • Eradication of H. pylori

    8 weeks

Interventions

RebamipideDRUG

rebamipide use for ttt of h.pylori infection

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patient with h.pylori infection from assiut university hospital

You may qualify if:

  • years of age or older,
  • ulcer size, 5 mm or more in longest diameter,
  • single ulcer,
  • H. pylori positively.

You may not qualify if:

  • use of medications such as PPIs, H2-receptor antagonists, other gastroprotective drugs, or nonsteroidal anti-inflammatory drugs within a week prior to the start of the trial, (2) previous eradication therapy for H. pylori, (3) acute or duodenal ulcer, (4) gastric ulcer with high risk of massive bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

rebamipide

Central Study Contacts

marwa ahmed abdelrahman

CONTACT

00201201777557m.hazem75@icloud.com

zain elabdeen sayed, professur

CONTACT

00201115596820zainsayed@aun.edu.eg

Study Design

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

Study Record Dates

First Submitted

August 21, 2020

First Posted

September 16, 2020

Study Start

September 5, 2020

Primary Completion

August 21, 2021

Study Completion

September 21, 2021

Last Updated

September 16, 2020

Record last verified: 2020-09