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

C

Chuncheon Sacred Heart Hospital

Status and phase

Completed
Phase 4

Conditions

Helicobacter Pylori Infection

Treatments

Drug: Trimebutine 100 MG

Study type

Interventional

Funder types

Other

Identifiers

NCT04403087
BCSHPAE

Details and patient eligibility

About

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.

Full 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.

Enrollment

132 patients

Sex

All

Ages

18+ years old

Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

132 participants in 2 patient groups

Trimebutine add group
Experimental group
Description:
Addition of Trimebutine on the Bismuth-containing quadruple regimen
Treatment:
Drug: Trimebutine 100 MG
Control group
No Intervention group
Description:
Bismuth-containing quadruple regimen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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