Helicobacter Pylori InfectionNCT04674774
Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection
A study testing Tegoprazan and Lansoprazole in people with Helicobacter Pylori Infection, run by Incheon St.Mary's Hospital at 1 site in South Korea.
Trial summary
This study aims to investigate eradication rate, drug compliance, and adverse events in patients with confirmed Helicobacter pylori infection between tegoprazan, bismuth, metronidazole, and tetracycline for 14 days (TBMT) and PPI, bismuth, metronidazole, and tetracycline for 14 days (LBMT) Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Tegoprazan and Lansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Mar 2021to 31 Mar 2022
- Phase
- Interventional
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who male or female aged 19 to 75 years old and fall under the following conditions with confirmed helicobacter pylori infection
Who cannot join
- patients who have H.pylori eradication history
- patients with history of gastric cancer surgery
- patients who have taken antibiotics within 4 weeks prior to trial
- a person who taking HIV protease inhibitors (atazanavir, nelfinavir) or a drug containing rilpivirine
- pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Tegoprazan Based Bismuth Quadruple Therapy Compared With Bismuth Quadruple Therapy for Helicobacter Pylori Infection: Randomized, Double-blind, Active-Controlled Study
This study aims to investigate eradication rate, drug compliance, and adverse events in patients with confirmed Helicobacter pylori infection between tegoprazan, bismuth, metronidazole, and tetracycline for 14 days (TBMT) and PPI, bismuth, metronidazole, and tetracycline for 14 days (LBMT)
Read the detailed description
This is a multi-center, double-blind, randomized, active-controlled study.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Tegoprazan, Lansoprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegoprazanDrug
oral administration of tegoprazan-based bismuth quadruple therapy(tegoprazan 50 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 days
LansoprazoleDrug
oral administration of PPI-based bismuth quadruple therapy(lansoprazole 30 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 day
| Study group | Role | What they receive |
|---|---|---|
| tegoprazan based bismuth quadruple therapy group | Experimental | tegoprazan based bismuth quadruple therapy group Receives: Drug: Tegoprazan |
| PPI based bismuth quadruple therapy group | Active comparator | PPI based bismuth quadruple therapy group Receives: Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate of each group
- pylori eradication rate of each group
Measured: UBT test 4 weeks after completion of eradication treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start4 Mar 2021
- Primary completion28 Feb 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Sung Kim, Incheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674774
- Sponsor's protocol ID
- OC20MIDI0057
- Status last verified
- Jan 2022
- First submitted
- 14 Dec 2020
- Last updated
- 10 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tegoprazan Based Bismuth Quadruple Therapy Compared With Bismuth Quadruple Therapy for Helicobacter Pylori Infection: Randomized, Double-blind, Active-Controlled Study
- ClinicalTrials.gov ID
- NCT04674774
- Acronym / sponsor ID
- OC20MIDI0057
- Conditions
- Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 19 Dec 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.
This study aims to investigate eradication rate, drug compliance, and adverse events in patients with confirmed Helicobacter pylori infection between tegoprazan, bismuth, metronidazole, and tetracycline for 14 days (TBMT) and PPI, bismuth, metronidazole, and tetracycline for 14 days (LBMT)
Detailed description
This is a multi-center, double-blind, randomized, active-controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tegoprazan based bismuth quadruple therapy group | Experimental | Drug: Tegoprazantegoprazan based bismuth quadruple therapy group |
| PPI based bismuth quadruple therapy group | Active comparator | Drug: LansoprazolePPI based bismuth quadruple therapy group |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who male or female aged 19 to 75 years old and fall under the following conditions with confirmed helicobacter pylori infection
Key exclusion criteria (5 listed)
- patients who have H.pylori eradication history
- patients with history of gastric cancer surgery
- patients who have taken antibiotics within 4 weeks prior to trial
- a person who taking HIV protease inhibitors (atazanavir, nelfinavir) or a drug containing rilpivirine
- pregnant or breastfeeding women
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 |
|---|---|---|
| Tegoprazanoral administration of tegoprazan-based bismuth quadruple therapy(tegoprazan 50 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 days | Drug | tegoprazan based bismuth quadruple therapy group |
| Lansoprazoleoral administration of PPI-based bismuth quadruple therapy(lansoprazole 30 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 day | Drug | PPI based bismuth quadruple therapy group |
Primary outcome
H. pylori eradication rate of each group
Time frame: UBT test 4 weeks after completion of eradication treatment
H. pylori eradication rate of each group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tegoprazan and Lansoprazole in people with Helicobacter Pylori Infection, run by Incheon St.Mary's 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 5 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: status not confirmed, as of the sponsor's last update on 10 Feb 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.
Are results available for this study?
Results are not available in the source record.
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?
H. pylori eradication rate of each group (time frame: UBT test 4 weeks after completion of eradication treatment). 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 10 Feb 2022.