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The Efficacy and Safety of the Combination Therapy of Keverprazan Hydrochloride Tablets and Amoxicillin for Helicobacter pylori-positive Chronic Gastritis: A Prospective, Multicenter, Randomized Controlled Study

The Efficacy and Safety of the Combination Therapy of Keverprazan Hydrochloride Tablets and Amoxicillin for Helicobacter pylori-positive Chronic Gastritis: A Prospective, Multicenter, Randomized Controlled Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107181
Enrollment
Unknown
Registered
2025-08-05
Start date
2025-08-13
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Helicobacter pylori gastritis

Interventions

Group 1 of keverprazan combined with amoxicillin:Keverprazan 20 mg, twice daily (bid) + amoxicillin 1 g, bid, for 14 days
Group 2 of keverprazan combined with amoxicillin:Keverprazan 20 mg, twice daily (bid) + amoxicillin 1 g, 3 times a day (tid), for 14 days.

Sponsors

The First AfiliatedHospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.18 years old <= age <= 65 years old, gender is not limited; 2. Helicobacter pylori (Hp) test is positive (confirmed by 13C-urea breath test, 14C-urea breath test, HE staining or bacterial culture); 3. No history of Hp eradication treatment; 4. Endoscopy report within the past year confirms chronic gastritis; 5. Able to independently complete the diary card of the subject; 6. Fully understand the content of the trial, voluntarily participate in the trial and be able to complete the trial process, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Active peptic ulcer with complications such as bleeding, perforation, obstruction, and cancer; 2. Previous history of esophageal or gastric surgery; 3. Severe systemic disease, major organs such as heart, lung, brain disease, liver and kidney dysfunction, other malignant tumors or other diseases; 4. Known allergy to Keverprazan, amoxicillin and related excipients (such as mannitol, microcrystalline cellulose, cross-linked polyvinylpyrrolidone, hydroxypropyl cellulose, magnesium stearate, etc.); 5. Pregnant or lactating women; 6. Long-term alcohol abuse or any other situation that increases the risk of adverse drug reactions; 7. Participated in other acid-reducing drug studies within the past 3 months, unable to express their thoughts correctly or unable to cooperate with researchers; 8. Researchers believe that other participants are not suitable for the trial.

Design outcomes

Primary

MeasureTime frame
Hp eradication rate after 4 weeks of eradication therapy;

Countries

China

Contacts

Public ContactChengdang Wang

The First AfiliatedHospital of Fujian Medical University

wangcdhl@sina.com+86 131 7811 1141

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026