Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications

Additive Effect of Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications; an Open-label, Randomized Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04403087

Enrollment

132

Registered

2020-05-27

Start date

2021-05-01

Completion date

2021-07-01

Last updated

2022-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

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.

Detailed description

Adverse events related to the eradication medication is one of the reason of lower eradication success in the H. pylori treatment. The common adverse events related to the eradication medications area as follows; Abdomen discomfort, pain, nausea, vomiting, diarrhea, bloating, urticaria, dizziness, headache, etc,. Various methods have been tried to reduce or prevent the adverse events related to the eradication medications. However, there is no established methods to reduce or prevent these events. 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.

Interventions

DRUGTrimebutine 100 MG

Trimebutine 100mg three times a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Overall compliance of eradication medication	2 weeks after prescription of eradication medication	How much the enrolled subjects took prescribed eradication medication

Secondary

Measure	Time frame	Description
Adverse events related to eradication medication	2 weeks and 6 weeks after prescription of eradication medication	percentage of Adverse events related to eradication medication

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026