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NCT04403087 Clinical Trial

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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04403087
Other study ID # BCSHPAE
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 1, 2021
Est. completion date July 1, 2021

Study information
Verified date July 2022
Source Chuncheon Sacred Heart Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date July 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Trimebutine 100 MG
Trimebutine 100mg three times a day

Locations
Country Name City State
Korea, Republic of Chuncheon Sacred Heart hospital Chuncheon Gangwon

Sponsors (1)
Lead Sponsor Collaborator
Chuncheon Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall compliance of eradication medication How much the enrolled subjects took prescribed eradication medication 2 weeks after prescription of eradication medication
Secondary Adverse events related to eradication medication percentage of Adverse events related to eradication medication 2 weeks and 6 weeks after prescription of eradication medication
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