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Helicobacter Pylori InfectionPhase 3NCT05577468

Efficacy and Safety of Tegoprazan Versus Esomeprazole-containing Bismuth Quadruple Therapy for Eradication of Helicobacter Pylori

A Phase 3 study testing Tegoprazan in people with Helicobacter Pylori Infection, run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a multicenter, randomized, double-blind, double-dummy, phase III study to evaluate the efficacy and safety of tegoprazan versus esomeprazole-containing bismuth quadruple therapy in patients infected with Helicobacter pylori in China. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Helicobacter Pylori Infection
What is being tested?
Tegoprazan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
561 participants
Where
1 siteChina
Study dates
30 Oct 2022to 30 Sep 2023
Phase
Phase 3
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) Subjects who volunteer to sign the written informed consent form approved by the Ethics Committee and agree to participate in this study prior to the initiation of any study procedures.
  • 2) Subjects who are able to understand and follow the protocol requirements and agree to participate in all the study visits.
  • 3) Males or females ≥18 years old and ≤70 years old. 4) In the screening stage, subjects are confirmed Hp infection by 13^C-urea breath test , histology test and bacterial culture, and then the investigators judge that Hp eradication treatment is required.
  • 5) Subjects who agree to use appropriate medical method for contraception during the course of the study (not including women in medically sterile state)

Who cannot join

  • 1) Subjects received Hp eradication treatment previously. 2) Subjects who have participated in other clinical studies within 4 weeks before screening, except for the following two situations:
  • The study which the subject is participating or participated in is a non-interventional study (e.g. observational study or questionnaire survey); Subject had signed the informed consent form in that study, but withdrew from that study prior to the start of any treatment.
  • Subjects who have participated in the [NC821604] study and have demonstrated ulcer healing may participate in this study.
  • 3) Subjects who participated in the planning and execution of this study. 4) Women who are pregnant or breastfeeding. 5) Subjects with known allergy to tegoprazan, esomeprazole, penicillins or other β-lactams, macrolide antibiotics or bismuth (including any related excipients). If a skin sensitivity test (skin test) is required, it should be carried out at Visit 1 according to routine medical practice.
  • 6) Subjects with a history of drug (including but not limited to opioids) abuse or alcohol abuse within 1 year before the screening visit.
  • 7) Subjects with Zollinger-Ellison syndrome. 8) Subjects who have previously undergone surgery or operations that may affect gastric acid secretion or drug absorption, 9) Subjects with "warning" symptoms such as painful swallowing, severe dysphagia, bleeding, weight loss, anemia, or blood in the stool that may indicate malignant lesions of the gastrointestinal tract, unless the possibility of malignant lesions is ruled out by endoscopy.
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  • 10) Subjects with a history of malignant tumor within 5 years before screening 11) Subjects who cannot undergo upper gastrointestinal endoscopy. 12) Subjects whose upper gastrointestinal endoscopy demonstrates acute upper gastrointestinal bleeding, active gastric ulcer or duodenal ulcer, acute gastric mucosal injury or duodenal mucosal injury.
  • 13) Subjects with uncontrolled and unstable hepatic, renal, cardiovascular, respiratory, gastrointestinal, endocrine, hematologic, central nervous system or mental diseases as judged by investigators, in which participation in the study may affect the interpretation of their safety or research results.
  • 14) Subjects who plan to be hospitalized for surgical treatment during the study.
  • 15) Subjects who have taken H2 receptor antagonists or PPI within 14 days before the 13C-urea breath test during the screening period, or those who have taken antibacterial drugs, bismuth and certain Chinese medicines with antibacterial effects within 28 days before the 13C-urea breath test during the screening period.
  • 16) Subjects who need to use the prohibited drugs listed in the protocol. 17) Subjects with any of the following laboratory test abnormalities at screening:
  • AST > upper limit of normal (ULN);
  • ALT > ULN;
  • Total bilirubin > 1.2 × ULN;
  • Creatinine > 1.5 × ULN; 18) Subjects with clinically significant electrocardiogram (ECG) abnormalities at the screening as judged by investigators.
  • 19) Human immunodeficiency virus (HIV) antibody positive, hepatitis B virus (HBV) surface antigen positive or hepatitis C virus (HCV) antibody positive confirmed by tests.
  • 20) Judged by the investigator, there are other conditions compromising the subject's eligibility for this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Double-dummy Phase III Clinical Study to Evaluate the Efficacy and Safety of Tegoprazan Versus Esomeprazole-containing Bismuth Quadruple Therapy for Eradication of Helicobacter Pylori

This study is a multicenter, randomized, double-blind, double-dummy, phase III study to evaluate the efficacy and safety of tegoprazan versus esomeprazole-containing bismuth quadruple therapy in patients infected with Helicobacter pylori in China.

Screening phase: After signing the informed consent form, subjects will be determined for Helicobacter pylori infection by 13^C-urea breath test (UBT),histological testing and bacterial culture during the screening period. Subjects who meet all screening criteria will be randomized in a 1:1 ratio to receive the tegoprazan-containing bismuth quadruple therapy (hereinafter referred to as the tegoprazan group) or esomeprazole-containing bismuth quadruple therapy (hereinafter referred to as the esomeprazole group).

Read more

Treatment phase: Subjects will receive relevant study medication starting on Day 1 of the treatment period for 14 days.

Follow-up phase: Within 29+7 days after the last study drug treatment, subjects will return to the study site for efficacy and safety assessments. 13^C-UBT detection will be performed in this follow-up visit to determine the Hp infection status of the subjects after treatment.

Being tested
Tegoprazan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TegoprazanDrug

    tegoprazan-containing bismuth quadruple therapy or Esomeprazole-containing bismuth quadruple therapy; Route of administration: oral;

Study groups in NCT05577468
Study groupRoleWhat they receive
tegoprazanExperimentalParticipants will receive Tegoprazan tablets Esomeprazole magnesium enteric-coated tablets placebo Bismuth potassium citrate capsules Amoxicillin capsules Clarithromycin tablets
Receives: Drug: Tegoprazan
EsomeprazoleActive comparatorParticipants will receive Tegoprazan tablets placebo Esomeprazole magnesium enteric-coated tablets Bismuth potassium citrate capsules Amoxicillin capsules Clarithromycin tablets
Receives: Drug: Tegoprazan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of All Participants With Successful Helicobacter Pylori (H.Pylori) Eradication

    Percentage of all patients with Hp eradication determined by a 13^C-urea breath test after study treatment.

    Measured: Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)

Secondary outcomes (4)

  1. Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline

    Measured: Day 29+7 days following the completion of treatment( duration of treatment was 2 weeks)

  2. Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Clarithromycin-sensitive Strain of H Pylori at Baseline

    Measured: Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)

  3. Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Amoxicillin-resistant Strain of H Pylori at Baseline

    Measured: Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)

  4. Percentage of Participants With Successful Helicobacter Pylori (H.Pylori) Eradication in Participants With a Amoxicillin-sensitive Strain of H Pylori at Baseline

    Measured: Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start30 Oct 2022
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
561 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05577468
Sponsor's protocol ID
NC822101
Status last verified
Jan 2024
First submitted
9 Oct 2022
Last updated
10 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Song Z, Wang W, Li P, Zuo X, Zhu Y, Chen Y, Zhang X, Lyu B, Lin R, Du Y, Lan C, Wu H, Chen W, Ye Y, Fan H, Liao A, Chen H, Liu C, Zhang Z, Wang W, Suo Z, Li X, Du Q, Li X, Pan F, Tang J, Xu M, Liu X, Zheng P, Chen H, Du L, Lu J, Feng C, Pan W, Wang H, Zeng Z, Wang J, Lyu S, Liu D, Yang S, Li L, Zhou L. Tegoprazan-based versus esomeprazole-based triple therapy plus bismuth for first-line Helicobacter pylori eradication: A nationwide, multicenter, double-blind, double-dummy, randomized controlled trial. Chin Med J (Engl). 2025 Aug 22. doi: 10.1097/CM9.0000000000003780. Online ahead of print.

    PubMed 40846665

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tegoprazan in people with Helicobacter Pylori Infection, run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. 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 4 inclusion and 17 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 10 Jan 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Percentage of All Participants With Successful Helicobacter Pylori (H.Pylori) Eradication (time frame: Day 29+7 days following the completion of treatment(duration of treatment was 2 weeks)). 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 NCT05577468, which also lists 1 linked publication.

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 Jan 2024.

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