HELICOBACTER PYLORI INFECTIONSPhase 4FAST-HPNCT07242443
Tegoprazan Plus Amoxicillin BID vs TID Regimens for H. Pylori Eradication（Frequency Adjusted Same-dose Therapy for H. Pylori）
A Phase 4 study testing Tegoprazan 50 mg, Amoxicillin 1 g TID and Amoxicillin 1.5 g BID in people with HELICOBACTER PYLORI INFECTIONS, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
This study is designed to evaluate two different tegoprazan-based dual therapy regimens for the treatment of Helicobacter pylori (H. pylori) infection. All participants will receive tegoprazan 50 mg twice daily for 14 days, combined with one of two amoxicillin dosing schedules that contain the same total daily dose of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- Tegoprazan 50 mg, Amoxicillin 1 g TID and Amoxicillin 1.5 g BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Adults aged 18 to 70 years. 2.Confirmed Helicobacter pylori infection by ¹³C-urea breath test, stool antigen test, or gastric biopsy.
- 3.Able to provide written informed consent. 4.Willing and able to comply with all study procedures, including follow-up testing 4-8 weeks after treatment.
Who cannot join
- 1.Known allergy or hypersensitivity to tegoprazan, amoxicillin, or any β-lactam antibiotics.
- 2.Use of antibiotics, proton pump inhibitors (PPIs), bismuth-containing agents, or potassium-competitive acid blockers within 4 weeks before screening.
- 3.Severe hepatic impairment (ALT or AST > 3 × upper limit of normal). 4.Severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m²).
- 5.Pregnant or breastfeeding women. 6.History of gastric surgery or conditions that may affect gastrointestinal absorption.
- 7.Participation in another clinical trial within the past 30 days. 8.Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
Hongzhang Shen, PhD/MD, +86-150-6717-4028, shz@zcmu.edu.cn
About this study
Official title: A Randomized Controlled Trial Comparing Tegoprazan 50 mg BID Combined With Amoxicillin 1 g TID Versus Tegoprazan 50 mg BID Combined With Amoxicillin 1.5 g BID for the Eradication of Helicobacter Pylori
This study is designed to evaluate two different tegoprazan-based dual therapy regimens for the treatment of Helicobacter pylori (H. pylori) infection. All participants will receive tegoprazan 50 mg twice daily for 14 days, combined with one of two amoxicillin dosing schedules that contain the same total daily dose of 3 grams of amoxicillin.
One group will receive amoxicillin 1 gram three times daily (TID), which is the standard regimen. The other group will receive amoxicillin 1.5 grams twice daily (BID), an alternative schedule that may improve convenience and treatment adherence while maintaining the same total daily antibiotic amount.
A total of 240 adults with confirmed H. pylori infection will be randomly assigned to one of the two treatment groups. The main goal of the study is to compare the H. pylori eradication rates between the two regimens. Eradication will be assessed 4 to 8 weeks after completing therapy using a ¹³C-urea breath test. Safety, tolerability, and medication adherence will also be monitored.
Read the detailed description
Helicobacter pylori (H. pylori) infection is a common and clinically important condition associated with peptic ulcer disease, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer. Effective eradication remains essential for reducing long-term complications. Traditional proton pump inhibitor (PPI)-based regimens have faced challenges due to rising antibiotic resistance and suboptimal acid suppression.
Tegoprazan is a potassium-competitive acid blocker (P-CAB) that provides rapid, potent, and sustained gastric acid inhibition, which may enhance the effectiveness of amoxicillin-based dual therapy. Amoxicillin resistance remains low in many regions, and its efficacy is closely related to maintaining intragastric pH levels that support bacterial replication.
The standard tegoprazan dual therapy uses amoxicillin 1 gram three times daily (TID). However, TID dosing may affect patient adherence, which can influence eradication outcomes. This study explores an alternative regimen: amoxicillin 1.5 grams twice daily (BID). The two regimens deliver the same total daily dose of 3 grams of amoxicillin, but the BID schedule may improve convenience and medication compliance while maintaining appropriate pharmacodynamic exposure.
This randomized, controlled clinical trial is designed to compare the eradication efficacy, safety, and tolerability of these two dosing strategies in adults with confirmed H. pylori infection. By evaluating whether a simplified BID regimen can achieve non-inferior or superior eradication rates compared with the standard TID regimen, the study aims to provide evidence that may support more convenient dual therapy options for H. pylori management.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- Tegoprazan 50 mg, Amoxicillin 1 g TID, Amoxicillin 1.5 g BID
- Keywords
- Helicobacter pylori, H. pylori, Amoxicillin, Tegoprazan, Dual Therapy, BID Dosing, TID Dosing, Fixed-Dose Regimen, P-CAB, Frequency Comparison, Antibiotic Regimen Optimization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegoprazan 50 mgDrug
Tegoprazan 50 mg administered orally twice daily (BID) for 14 days.
Amoxicillin 1 g TIDDrug
Amoxicillin 1 gram administered orally three times daily (TID) for 14 days.
Amoxicillin 1.5 g BIDDrug
Amoxicillin 1.5 grams administered orally twice daily (BID) for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan 50 mg BID + Amoxicillin 1 g TID | Active comparator | Participants in this arm will receive tegoprazan 50 mg orally twice daily (BID) in combination with amoxicillin 1 gram orally three times daily (TID) for 14 days. This regimen represents the standard dual therapy dosing schedule for Helicobacter pylori eradication. Receives: Drug: Tegoprazan 50 mg; Drug: Amoxicillin 1 g TID |
| Tegoprazan 50 mg BID + Amoxicillin 1.5 g BID | Experimental | Participants in this arm will receive tegoprazan 50 mg orally twice daily (BID) in combination with amoxicillin 1.5 grams orally twice daily (BID) for 14 days. This regimen delivers the same total daily dose of amoxicillin (3 grams) as the standard therapy but uses a reduced dosing frequency to evaluate whether a BID schedule can improve convenience, adherence, and eradication outcomes. Receives: Drug: Tegoprazan 50 mg; Drug: Amoxicillin 1.5 g BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori Eradication Rate
Eradication of Helicobacter pylori infection confirmed by a negative ¹³C-urea breath test performed 4 to 8 weeks after the end of the 14-day treatment regimen.
Measured: 4 to 8 weeks after completion of therapy
Secondary outcomes (4)
Incidence of Adverse Events
The number and proportion of participants reporting any adverse events during the 14-day treatment period, assessed by patient report, clinical evaluation, and laboratory findings.
Measured: From Day 1 to Day 14 (treatment period)
Incidence of Serious Adverse Events (SAEs)
Serious adverse events, defined according to standard regulatory criteria (life-threatening events, hospitalization, significant disability, or other medically significant events).
Measured: From Day 1 to study completion (approximately 8-10 weeks)
Medication Adherence Rate
Adherence assessed by pill count and participant self-report. Adherence will be expressed as the percentage of prescribed doses actually taken during the 14-day treatment period.
Measured: Day 1 to Day 14
Change in Gastrointestinal Symptom Scores
Improvement in gastrointestinal symptoms (such as epigastric discomfort, bloating, nausea), assessed using a standardized symptom questionnaire. Higher scores indicate more severe symptoms.
Measured: Baseline to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies 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
- Model description
- This is a randomized, two-arm, parallel-group study in which participants are allocated in a 1:1 ratio to receive tegoprazan plus amoxicillin 1 g TID or tegoprazan plus amoxicillin 1.5 g BID for 14 days.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242443
- Sponsor's protocol ID
- HP-TGZ-AMO-3g-FrequencyStudy
- Other IDs
- BCF-LX-XH-20221014-26
- Acronym
- FAST-HP
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data (IPD) has not yet been determined. A decision regarding IPD sharing will be made after the completion of the study and review of institutional policies and publication requirements.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Tegoprazan 50 mg BID Combined With Amoxicillin 1 g TID Versus Tegoprazan 50 mg BID Combined With Amoxicillin 1.5 g BID for the Eradication of Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT07242443
- Acronym / sponsor ID
- FAST-HP / HP-TGZ-AMO-3g-FrequencyStudy
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- Helicobacter pylori, H. pylori, Amoxicillin, Tegoprazan, Dual Therapy, BID Dosing, TID Dosing, Fixed-Dose Regimen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Nov 2025 (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 is designed to evaluate two different tegoprazan-based dual therapy regimens for the treatment of Helicobacter pylori (H. pylori) infection. All participants will receive tegoprazan 50 mg twice daily for 14 days, combined with one of two amoxicillin dosing schedules that contain the same total daily dose of 3 grams of amoxicillin.
One group will receive amoxicillin 1 gram three times daily (TID), which is the standard regimen. The other group will receive amoxicillin 1.5 grams twice daily (BID), an alternative schedule that may improve convenience and treatment adherence while maintaining the same total daily antibiotic amount.
A total of 240 adults with confirmed H. pylori infection will be randomly assigned to one of the two treatment groups. The main goal of the study is to compare the H. pylori eradication rates between the two regimens. Eradication will be assessed 4 to 8 weeks after completing therapy using a ¹³C-urea breath test. Safety, tolerability, and medication adherence will also be monitored.
Detailed description
Helicobacter pylori (H. pylori) infection is a common and clinically important condition associated with peptic ulcer disease, gastric mucosa-associated lymphoid tissue lymphoma, and gastric cancer. Effective eradication remains essential for reducing long-term complications. Traditional proton pump inhibitor (PPI)-based regimens have faced challenges due to rising antibiotic resistance and suboptimal acid suppression.
Tegoprazan is a potassium-competitive acid blocker (P-CAB) that provides rapid, potent, and sustained gastric acid inhibition, which may enhance the effectiveness of amoxicillin-based dual therapy. Amoxicillin resistance remains low in many regions, and its efficacy is closely related to maintaining intragastric pH levels that support bacterial replication.
The standard tegoprazan dual therapy uses amoxicillin 1 gram three times daily (TID). However, TID dosing may affect patient adherence, which can influence eradication outcomes. This study explores an alternative regimen: amoxicillin 1.5 grams twice daily (BID). The two regimens deliver the same total daily dose of 3 grams of amoxicillin, but the BID schedule may improve convenience and medication compliance while maintaining appropriate pharmacodynamic exposure.
This randomized, controlled clinical trial is designed to compare the eradication efficacy, safety, and tolerability of these two dosing strategies in adults with confirmed H. pylori infection. By evaluating whether a simplified BID regimen can achieve non-inferior or superior eradication rates compared with the standard TID regimen, the study aims to provide evidence that may support more convenient dual therapy options for H. pylori management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, two-arm, parallel-group study in which participants are allocated in a 1:1 ratio to receive tegoprazan plus amoxicillin 1 g TID or tegoprazan plus amoxicillin 1.5 g BID for 14 days.
| Arm | Type | Receives |
|---|---|---|
| Tegoprazan 50 mg BID + Amoxicillin 1 g TID | Active comparator | Drug: Tegoprazan 50 mg, Drug: Amoxicillin 1 g TIDParticipants in this arm will receive tegoprazan 50 mg orally twice daily (BID) in combination with amoxicillin 1 gram orally three times daily (TID) for 14 days. This regimen represents the standard dual therapy dosing schedule for Helicobacter pylori eradication. |
| Tegoprazan 50 mg BID + Amoxicillin 1.5 g BID | Experimental | Drug: Tegoprazan 50 mg, Drug: Amoxicillin 1.5 g BIDParticipants in this arm will receive tegoprazan 50 mg orally twice daily (BID) in combination with amoxicillin 1.5 grams orally twice daily (BID) for 14 days. This regimen delivers the same total daily dose of amoxicillin (3 grams) as the standard therapy but uses a reduced dosing frequency to evaluate whether a BID schedule can improve convenience, adherence, and eradication outcomes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1.Adults aged 18 to 70 years. 2.Confirmed Helicobacter pylori infection by ¹³C-urea breath test, stool antigen test, or gastric biopsy.
- 3.Able to provide written informed consent. 4.Willing and able to comply with all study procedures, including follow-up testing 4-8 weeks after treatment.
Key exclusion criteria (5 listed)
- 1.Known allergy or hypersensitivity to tegoprazan, amoxicillin, or any β-lactam antibiotics.
- 2.Use of antibiotics, proton pump inhibitors (PPIs), bismuth-containing agents, or potassium-competitive acid blockers within 4 weeks before screening.
- 3.Severe hepatic impairment (ALT or AST > 3 × upper limit of normal). 4.Severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m²).
- 5.Pregnant or breastfeeding women. 6.History of gastric surgery or conditions that may affect gastrointestinal absorption.
- 7.Participation in another clinical trial within the past 30 days. 8.Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.
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 |
|---|---|---|
| Tegoprazan 50 mgTegoprazan 50 mg administered orally twice daily (BID) for 14 days. | Drug | Tegoprazan 50 mg BID + Amoxicillin 1 g TID, Tegoprazan 50 mg BID + Amoxicillin 1.5 g BID |
| Amoxicillin 1 g TIDAmoxicillin 1 gram administered orally three times daily (TID) for 14 days. | Drug | Tegoprazan 50 mg BID + Amoxicillin 1 g TID |
| Amoxicillin 1.5 g BIDAmoxicillin 1.5 grams administered orally twice daily (BID) for 14 days. | Drug | Tegoprazan 50 mg BID + Amoxicillin 1.5 g BID |
Primary outcome
H. pylori Eradication Rate
Time frame: 4 to 8 weeks after completion of therapy
Eradication of Helicobacter pylori infection confirmed by a negative ¹³C-urea breath test performed 4 to 8 weeks after the end of the 14-day treatment regimen.
4 secondary outcomes
Incidence of Adverse Events
Time frame: From Day 1 to Day 14 (treatment period)
Incidence of Serious Adverse Events (SAEs)
Time frame: From Day 1 to study completion (approximately 8-10 weeks)
Medication Adherence Rate
Time frame: Day 1 to Day 14
Change in Gastrointestinal Symptom Scores
Time frame: Baseline to Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data (IPD) has not yet been determined. A decision regarding IPD sharing will be made after the completion of the study and review of institutional policies and publication requirements.
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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.
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 Tegoprazan 50 mg, Amoxicillin 1 g TID and Amoxicillin 1.5 g BID in people with HELICOBACTER PYLORI INFECTIONS, run by First People's Hospital of Hangzhou at 1 site in China.
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 2 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: opening soon, as of the sponsor's last update on 21 Nov 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongzhang Shen, PhD/MD (+86-150-6717-4028, shz@zcmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. pylori Eradication Rate (time frame: 4 to 8 weeks after completion of therapy). 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 21 Nov 2025.