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

NCT04403087 — Phase 4, Completed, 132 participants, Chuncheon Sacred Heart Hospital

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

Registry	NCT04403087
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	132 (Actual)
Sponsor	Chuncheon Sacred Heart Hospital (Other)
Conditions	Helicobacter Pylori Infection
Interventions	Trimebutine 100 MG (Drug)
Dates	start 2021-05-01, primary completion 2021-06-01, completion 2021-07-01, first posted 2020-05-27, last updated 2022-07-12
Locations	1 site in South Korea

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Trimebutine add group	Experimental	Drug: Trimebutine 100 MG	Addition of Trimebutine on the Bismuth-containing quadruple regimen
Control group	No intervention		Bismuth-containing quadruple regimen

Trimebutine 100 MG (Drug), also known as Polybutine (Samil Pharm.Co.,Ltd.): Trimebutine 100mg three times a day

+Outcome measures

Primary outcomes

Overall compliance of eradication medication [2 weeks after prescription of eradication medication]: How much the enrolled subjects took prescribed eradication medication

Secondary outcomes

Adverse events related to eradication medication [2 weeks and 6 weeks after prescription of eradication medication]: percentage of Adverse events related to eradication medication

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Chuncheon Sacred Heart hospital	Chuncheon, Gangwon-do	South Korea

+Investigators

Chang Seok Bang, MD, PHD, Principal investigator, Hallym University