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Keverprazan Hydrochloride Tablets dual therapy, quadruple therapy efficacy and safety of helicobacter pylori eradication study

Keverprazan Hydrochloride Tablets dual therapy, quadruple therapy efficacy and safety of helicobacter pylori eradication: a multicenter, open label, randomized controlled study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086821
Enrollment
Unknown
Registered
2024-07-11
Start date
2024-07-12
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

helicobacter pylori infection

Interventions

Keverprazan Hydrochloride Tablets dual therapy Ten days group:Keverprazan Hydrochloride Tablets 20mg bid and Amoxicillin 1g tid were administered for 10 days
Keverprazan Hydrochloride Tablets dual therapy fourteen days group:Keverprazan Hydrochloride Tablets 20mg bid and Amoxicillin 1g tid were administered for 14days
Keverprazan Hydrochloride Tablets quadruple therapy Ten days group:Keverprazan Hydrochloride Tablets 20mg bid, and Bismuth agent quadruple scheme (1 g amoxicillin and clarithromycin 500 mg, bismuth po

Sponsors

Shenzhen Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) 18 age 75 years old or less, or less gender not limited; 2) Positive test for Helicobacter pylori (Hp) (¹³ C-urea breath test, monoclonal stool antigen test, histological test, rapid urease test or serological test, any two positive results); 3) Always not received Hp eradication therapy; 4) Can independently accomplish the subjects diary card record of the subjects; 5) Subjects who fully understood the content of the trial, volunteered to participate in the trial and were able to complete the trial process, and signed the informed consent

Exclusion criteria

Exclusion criteria: 1) Into the group 2 weeks before used acid suppression drugs, such as proton pump inhibitors, competitive acid potassium ion blockers, histamine H2 receptor antagonist, etc., or into the group of four weeks before used antibiotics, bismuth agent, antimicrobial effect of traditional Chinese medicine; 2) Subjects who have undergone or are scheduled to undergo surgery affecting gastric acid secretion (e.g., upper gastrointestinal resection, vagotomy, etc.); 3) Into the group of the first six months of endoscopy confirmed patients with atrophic gastritis, active peptic ulcer, the digestive tract tumor; 4) Before or are currently Zolling - Ellison syndrome (zhuo - ai syndrome) or other excessive gastric acid secretion disease history subjects; 5) Serious systemic diseases, major organ diseases such as heart, lung, brain diseases, liver and kidney dysfunction, malignant tumors or other diseases; 6) Known to be allergic to caprasian, bismuth, clarithromycin or amoxicillin and related excipients (such as mannitol, microcrystalline cellulose, cross-linked povidone, hydroxypropyl cellulose, magnesium stearate, etc.); 7) Pregnant or lactating women; 8) Long-term alcohol or any other increase in risk treatment; 9) Not suitable for other participants' 9) researchers say.

Design outcomes

Primary

MeasureTime frame
eradication rate of Hp;

Secondary

MeasureTime frame
adverse event rate;

Countries

China

Contacts

Public ContactYe Chen

Shenzhen Hospital of Southern Medical University

yechen_fimmu@163.com+86 139 2229 3223

Outcome results

None listed

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