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Completed

NCT Number: NCT04403087

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

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chuncheon Sacred Heart hospital

Chuncheon, Gangwon-do, 24253, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trimebutine 100 MG

Drug

Trimebutine 100mg three times a day

Other names: Polybutine (Samil Pharm.Co.,Ltd.)

Primary outcomes

  1. Overall compliance of eradication medication

    Time frame: 2 weeks after prescription of eradication medication

    How much the enrolled subjects took prescribed eradication medication

Secondary outcomes

  1. Adverse events related to eradication medication

    Time frame: 2 weeks and 6 weeks after prescription of eradication medication

    percentage of Adverse events related to eradication medication

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 27, 2020
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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