Helicobacter Pylori InfectionPhase 4NCT04403087
Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications
A Phase 4 study testing Trimebutine 100 MG in people with Helicobacter Pylori Infection, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Trimebutine 100 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2021to 1 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Chuncheon Sacred Heart hospital
Chuncheon, Gangwon-do, 24253
About this study
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
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.
Read the 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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Trimebutine 100 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimebutine 100 MGDrug
Also called Polybutine (Samil Pharm.Co.,Ltd.)
Trimebutine 100mg three times a day
| Study group | Role | What they receive |
|---|---|---|
| Trimebutine add group | Experimental | Addition of Trimebutine on the Bismuth-containing quadruple regimen Receives: Drug: Trimebutine 100 MG |
| Control group | No intervention | Bismuth-containing quadruple regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall compliance of eradication medication
How much the enrolled subjects took prescribed eradication medication
Measured: 2 weeks after prescription of eradication medication
Secondary outcomes (1)
Adverse events related to eradication medication
percentage of Adverse events related to eradication medication
Measured: 2 weeks and 6 weeks after prescription of eradication medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 May 2021
- Primary completion1 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Seok Bang, Chuncheon Sacred Heart Hospital
- Investigators
- Chang Seok Bang, MD, PHD, Principal investigator, Hallym University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403087
- Sponsor's protocol ID
- BCSHPAE
- Status last verified
- Jul 2022
- First submitted
- 21 May 2020
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04403087
- Acronym / sponsor ID
- BCSHPAE
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trimebutine add group | Experimental | Drug: Trimebutine 100 MGAddition of Trimebutine on the Bismuth-containing quadruple regimen |
| Control group | No intervention | –Bismuth-containing quadruple regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimebutine 100 MGAlso: Polybutine (Samil Pharm.Co.,Ltd.)Trimebutine 100mg three times a day | Drug | Trimebutine add group |
Primary outcome
Overall compliance of eradication medication
Time frame: 2 weeks after prescription of eradication medication
How much the enrolled subjects took prescribed eradication medication
1 secondary outcome
Adverse events related to eradication medication
Time frame: 2 weeks and 6 weeks after prescription of eradication medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Seok Bang, MD, PHD principal investigator
Hallym University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trimebutine 100 MG in people with Helicobacter Pylori Infection, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall compliance of eradication medication (time frame: 2 weeks after prescription of eradication medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.