Helicobacter Pylori InfectionNCT05870683
Comparison of Two Dual Therapies in the First-line Treatment of Helicobacter Pylori Infection （SHARE2301）
A study testing Tegoprazan, Amoxicillin and Esomeprazole in people with Helicobacter Pylori Infection, run by Yanqing Li at 1 site in China.
Trial summary
Helicobacter pylori (H. pylori) infection is a common global infectious disease of the gastrointestinal tract. Helicobacter pylori eradication can effectively prevent the development of stomach cancer. Progressive application of dual therapy for the eradication of Helicobacter pylori. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Tegoprazan, Amoxicillin and Esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2023to 30 Dec 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Helicobacter pylori infection (either positive for histopathological test, rapid urease test, or C13/C14 urea breath test).
- Patients who have not previously received helicobacter pylori eradication therapy.
Who cannot join
- Serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumor, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%).
- Those who are not willing to take contraceptive measures during pregnancy, lactation or the trial.
- Active gastrointestinal bleeding.
- History of drug allergy.
- History of upper gastrointestinal surgery.
- Medication history of bismuth, antibiotics and PPI within 4 weeks.
- Other behaviors that may increase the risk, such as alcohol and drug abuse.
- Unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, PhD. MD., 18678827666, liyanqing@sdu.edu.cn
About this study
Official title: Comparison of the Efficacy of Tegoprazan-containing Versus Esomeprazole-containing Dual Therapy for Helicobacter Pylori Eradication: a Prospective, Multicenter, Randomized Controlled Study （SHARE2301）
Helicobacter pylori (H. pylori) infection is a common global infectious disease of the gastrointestinal tract. Helicobacter pylori eradication can effectively prevent the development of stomach cancer. Progressive application of dual therapy for the eradication of Helicobacter pylori. Tegoprazan, a Potassium-Competitive Acid Blockers. The efficacy of P-CAB agents represented by vonoprazan in H. pylori eradication therapy has been widely verified.
Read the detailed description
In 1989, it was suggested that amoxicillin combined with PPI could eradicate Hp infection, and in 2015, a prospective, multicenter, randomized controlled study in Taiwan with a large sample showed that the eradication rate of Hp could reach 96.6% with dual therapy for primary treatment of Hp infection, and the results of intention-to-treat analysis were as high as 95.3%. 95.3%. In 2020, a meta-analysis showed that high-dose dual therapy had the same efficacy and fewer side effects than other recommended regimens in first-line treatment. In terms of dosing days, multiple randomized controlled studies and meta-analyses from 2020-2021 have shown that 14 days of high-dose dual therapy is more effective in eradicating H. pylori.
Tegoprazan, a Potassium-Competitive Acid Blockers (P-CAB), is a new type of acid-suppressing drug that compensates for the short half-life of acid-activated traditional acid-suppressing PPI and the low mucosal healing rate due to insufficient acid suppression. The efficacy of P-CAB agents represented by vonoprazan in H. pylori eradication therapy has been widely verified. 2022, tegoprazan was approved by the State Drug Administration for the new indication of eradication of H. pylori infection in adults in combination with appropriate antimicrobial therapy, and its efficacy in clinical application has not yet been verified.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Tegoprazan, Amoxicillin, Esomeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegoprazanDrug
Included in dual eradication medication.
AmoxicillinDrug
Included in dual eradication medication.
EsomeprazoleDrug
Included in dual eradication medication.
| Study group | Role | What they receive |
|---|---|---|
| 14-day Tegoprazan-Amoxicillin dual therapy | Experimental | 14-day Tegoprazan-Amoxicillin dual therapy, Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid Receives: Drug: Tegoprazan; Drug: Amoxicillin |
| 14-day Esomeprazole-Amoxicillin dual therapy | Active comparator | 14-day Esomeprazole-Amoxicillin dual therapy, Esomeprazole（Astrazeneca Pharmaceutical Co., LTD.) 20mg qid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid Receives: Drug: Amoxicillin; Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 80% of the study medications and complete follow-up.
Measured: Immediately after follow-up check
Secondary outcomes (2)
Rate of adverse reactions
Rate of adverse reactions
Measured: Immediately after follow-up check
Patient compliance
good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken
Measured: Immediately after follow-up check
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start24 May 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanqing Li
- Sponsor type
- University, hospital or other
- Collaborators
- Linyi People's Hospital, Weifang Medical University, Zhengzhou Central Hospital, Yuncheng Traditional Chinese Medicine Hospital, The Affiliated Hospital of Qingdao University, The People's Hospital of Jimo, Shandong University of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870683
- Sponsor's protocol ID
- SHARE2301
- Status last verified
- Jul 2023
- First submitted
- 7 May 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.
PubMed 27707777Kong Q, Mirza IA, Zhang X, Song X, Li X, Zhang Q, Xu L, Guo Y, Yu Y, Zuo X, Li Y, Li Y. Fourteen-Day Tegoprazan-Amoxicillin Dual Therapy as the First-Line Treatment of Helicobacter pylori Infection (SHARE2301): A Multicenter, Noninferiority, Randomized Clinical Trial. Helicobacter. 2024 May-Jun;29(3):e13098. doi: 10.1111/hel.13098.
PubMed 38853394
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Tegoprazan-containing Versus Esomeprazole-containing Dual Therapy for Helicobacter Pylori Eradication: a Prospective, Multicenter, Randomized Controlled Study （SHARE2301）
- ClinicalTrials.gov ID
- NCT05870683
- Acronym / sponsor ID
- SHARE2301
- Conditions
- Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Yanqing LiUniversity, hospital or other
- Collaborators
- Linyi People's Hospital, Weifang Medical University, Zhengzhou Central Hospital, Yuncheng Traditional Chinese Medicine Hospital, The Affiliated Hospital of Qingdao University, The People's Hospital of Jimo, Shandong University of Traditional Chinese Medicine
- Study start
- 24 May 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 23 May 2023 (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.
Helicobacter pylori (H. pylori) infection is a common global infectious disease of the gastrointestinal tract. Helicobacter pylori eradication can effectively prevent the development of stomach cancer. Progressive application of dual therapy for the eradication of Helicobacter pylori. Tegoprazan, a Potassium-Competitive Acid Blockers. The efficacy of P-CAB agents represented by vonoprazan in H. pylori eradication therapy has been widely verified.
Detailed description
In 1989, it was suggested that amoxicillin combined with PPI could eradicate Hp infection, and in 2015, a prospective, multicenter, randomized controlled study in Taiwan with a large sample showed that the eradication rate of Hp could reach 96.6% with dual therapy for primary treatment of Hp infection, and the results of intention-to-treat analysis were as high as 95.3%. 95.3%. In 2020, a meta-analysis showed that high-dose dual therapy had the same efficacy and fewer side effects than other recommended regimens in first-line treatment. In terms of dosing days, multiple randomized controlled studies and meta-analyses from 2020-2021 have shown that 14 days of high-dose dual therapy is more effective in eradicating H. pylori.
Tegoprazan, a Potassium-Competitive Acid Blockers (P-CAB), is a new type of acid-suppressing drug that compensates for the short half-life of acid-activated traditional acid-suppressing PPI and the low mucosal healing rate due to insufficient acid suppression. The efficacy of P-CAB agents represented by vonoprazan in H. pylori eradication therapy has been widely verified. 2022, tegoprazan was approved by the State Drug Administration for the new indication of eradication of H. pylori infection in adults in combination with appropriate antimicrobial therapy, and its efficacy in clinical application has not yet been verified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 14-day Tegoprazan-Amoxicillin dual therapy | Experimental | Drug: Tegoprazan, Drug: Amoxicillin14-day Tegoprazan-Amoxicillin dual therapy, Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid |
| 14-day Esomeprazole-Amoxicillin dual therapy | Active comparator | Drug: Amoxicillin, Drug: Esomeprazole14-day Esomeprazole-Amoxicillin dual therapy, Esomeprazole（Astrazeneca Pharmaceutical Co., LTD.) 20mg qid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Helicobacter pylori infection (either positive for histopathological test, rapid urease test, or C13/C14 urea breath test).
- Patients who have not previously received helicobacter pylori eradication therapy.
Key exclusion criteria (8 listed)
- Serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumor, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%).
- Those who are not willing to take contraceptive measures during pregnancy, lactation or the trial.
- Active gastrointestinal bleeding.
- History of drug allergy.
- History of upper gastrointestinal surgery.
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 |
|---|---|---|
| TegoprazanIncluded in dual eradication medication. | Drug | 14-day Tegoprazan-Amoxicillin dual therapy |
| AmoxicillinIncluded in dual eradication medication. | Drug | 14-day Esomeprazole-Amoxicillin dual therapy, 14-day Tegoprazan-Amoxicillin dual therapy |
| EsomeprazoleIncluded in dual eradication medication. | Drug | 14-day Esomeprazole-Amoxicillin dual therapy |
Primary outcome
Eradication rate
Time frame: Immediately after follow-up check
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 80% of the study medications and complete follow-up.
2 secondary outcomes
Rate of adverse reactions
Time frame: Immediately after follow-up check
Patient compliance
Time frame: Immediately after follow-up check
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Results publication: PubMed 27707777Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.
- Derived from this study: PubMed 38853394Kong Q, Mirza IA, Zhang X, Song X, Li X, Zhang Q, Xu L, Guo Y, Yu Y, Zuo X, Li Y, Li Y. Fourteen-Day Tegoprazan-Amoxicillin Dual Therapy as the First-Line Treatment of Helicobacter pylori Infection (SHARE2301): A Multicenter, Noninferiority, Randomized Clinical Trial. Helicobacter. 2024 May-Jun;29(3):e13098. doi: 10.1111/hel.13098.
- 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.
Yanqing Li study chair
Qilu Hospital of Shandong University
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, Amoxicillin and Esomeprazole in people with Helicobacter Pylori Infection, run by Yanqing Li 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 8 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 11 Jul 2023. 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.
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?
Contact Yanqing Li, MD (18560086667, qlxhkqz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate (time frame: Immediately after follow-up check). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05870683, which also lists 2 linked publications.
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 11 Jul 2023.