Vonoprazan Hp Dual or Triple Eradication Regimes

Phase 4

Recruiting

• Conditions: Helicobacter Pylori
• Interventions: Drug: Vonoprazan Fumarate+Amoxycillin 7days (VA7); Drug: Vonoprazan Fumarate+Amoxycillin 14days (VA14); Drug: Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14); Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14); Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)

• Registration Number: NCT05345210
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief Summary

To evaluate the efficacy and safety of dual or triple regimes for Helicobacter Pylori eradication using Vonoprazan as the antiacid agent.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-19
• Study Start: 2022-04-25
• Study First Posted: 2022-04-25
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-20
• Primary Completion: 2023-02-28
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Age 18 to 70 years old, both gender is eligiable;
• Patients with definite Helicobacter Pylori infection (13C/14C urea breath test, rapid urease test and fecal Helicobacter Pylori antigen test positive) ;
• Voluntary to accept Helicobacter Pylori eradication treatment;
• Females of childbearing age are required to use medically acceptable contraceptive methods during the trial and within 30 days after the trial.

Exclusion Criteria

• Patients with contraindications to the study drug or allergic to the study drug;
• Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
• Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (at least 2 weeks before the examination for Helicobacter Pylori infection);
• Pregnant and lactating women;
• Have received upper gastrointestinal surgery;
• Symptoms of dysphagia;
• Evidence of bleeding or iron deficiency anemia;
• have a history of malignant tumor;
• History of drug or alcohol abuse within the past 1 year;
• Systemic application of glucocorticoids, non-steroidal anti-inflammatory drugs, anticoagulants, and platelet aggregation inhibitors (except aspirin ≤100 mg/d);
• Persons with mental disorders;
• Received other clinical trials within the past 3 months;
• Refused to sign the informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vonoprazan Fumarate+Amoxycillin 7days (VA7)	Vonoprazan Fumarate+Amoxycillin 7days (VA7)	Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 7 days
Vonoprazan Fumarate+Amoxycillin 14days (VA14)	Vonoprazan Fumarate+Amoxycillin 14days (VA14)	Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 14 days
Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14)	Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14)	Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po Clarithromycin 500mg bid po for 14 days
Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14)	Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14)	Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 14 days
Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)	Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)	Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 7 days

Primary Outcome Measures

Name	Time	Method
Helicobacter Pylori eradication rate	28 days after treatment	The primary end point of this study is H.pylori eradication,established by negative \[13C\] urea breath test 28 days after the end of eradication

Secondary Outcome Measures

Name	Time	Method
adverse events	14 days of treatment, and 28 days after treatment	Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain.
symptoms effective rates	14 days of treatment, and 28 days after treatment	symptoms effective rates Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom effective rate =#total score before treatment - total score after treatment#/total score before treatment x100%. Total score = frequency + severity.Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3presenting most severe

Trial Locations

Locations (1)

Xijing Hosipital of Digestive Disease; 🇨🇳 Xi'an, Shaanxi, China