NCT04403087

Brief Summary

Adverse events related to the eradication medication is one of the reason of lower eradication success in the H. pylori treatment. The aim of this study was to evaluate the additive effect of trimebutine for the development of adverse events related to the H. pylori eradication regimen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2021

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

May 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

1 month

First QC Date

May 21, 2020

Last Update Submit

July 9, 2022

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • Overall compliance of eradication medication

    How much the enrolled subjects took prescribed eradication medication

    2 weeks after prescription of eradication medication

Secondary Outcomes (1)

  • Adverse events related to eradication medication

    2 weeks and 6 weeks after prescription of eradication medication

Study Arms (2)

Trimebutine add group

EXPERIMENTAL

Addition of Trimebutine on the Bismuth-containing quadruple regimen

Drug: Trimebutine 100 MG

Control group

NO INTERVENTION

Bismuth-containing quadruple regimen

Interventions

Trimebutine 100 MGDRUG

Trimebutine 100mg three times a day

Also known as: Polybutine (Samil Pharm.Co.,Ltd.)
Trimebutine add group

Eligibility Criteria

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

You may qualify if:

  • Subjects who underwent upper gastrointestinal endoscopy and were proven to have H. pylori infection either by using the rapid urease test, the 13 C-urea breath test (UBT), or histological examination.

You may not qualify if:

  • Subjects who took medications as Proton pump inhibitor, Histamin-2 receptor antagonist and antibiotics,
  • Subjects who underwent stomach resection
  • Subjects less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chuncheon Sacred Heart hospital

Chuncheon, Gangwon-do, 24253, South Korea

Location

MeSH Terms

Interventions

Trimebutine

Intervention Hierarchy (Ancestors)

Hydroxybenzoate EthersHydroxybenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenols

Study Officials

  • Chang Seok Bang, MD, PHD

    Hallym University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 27, 2020

Study Start

May 1, 2021

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

July 12, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)