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

Phase 4

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Trimebutine 100 MG

• Registration Number: NCT04403087
• Lead Sponsor: Chuncheon Sacred Heart Hospital

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.

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Study Start: 2021-05-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-07-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-09
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trimebutine add group	Trimebutine 100 MG	Addition of Trimebutine on the Bismuth-containing quadruple regimen

Primary Outcome Measures

Name	Time	Method
Overall compliance of eradication medication	2 weeks after prescription of eradication medication	How much the enrolled subjects took prescribed eradication medication

Secondary Outcome Measures

Name	Time	Method
Adverse events related to eradication medication	2 weeks and 6 weeks after prescription of eradication medication	percentage of Adverse events related to eradication medication

Trial Locations

Locations (1)

Chuncheon Sacred Heart hospital; 🇰🇷 Chuncheon, Gangwon, Korea, Republic of