Vonoprazan Hp Dual or Triple Eradication Regimes

Sponsor

Xijing Hospital of Digestive Diseases (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05345210

Collaborator

(none)

500

Enrollment

Location

Arms

11.2

Anticipated Duration (Months)

44.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori	Drug: Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14) Drug: Vonoprazan Fumarate+Amoxycillin 14days (VA14) Drug: Vonoprazan Fumarate+Amoxycillin 7days (VA7) Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14) Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Helicobacter Pylori Eradication Dual or Triple Regimes Using Vonoprazan as the Antacid

Anticipated Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14) Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po Clarithromycin 500mg bid po for 14 days	Drug: Vonoprazan Fumarate+Amoxycillin+Clarithromycin 14days (VAC14) VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days
Experimental: Vonoprazan Fumarate+Amoxycillin 14days (VA14) Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 14 days	Drug: Vonoprazan Fumarate+Amoxycillin 14days (VA14) VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days
Experimental: Vonoprazan Fumarate+Amoxycillin 7days (VA7) Vonoprazan Fumarate 20mg bid po Amoxycillin 1000mg bid po for 7 days	Drug: Vonoprazan Fumarate+Amoxycillin 7days (VA7) VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days
Experimental: Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14) Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 14 days	Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 14days (VTF14) VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days VA-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 14 days VA-7d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po for 7 days VTF-14d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 14 days VTF-7d:Vonoprazan Fumarate 20mg bid po, Tetracycline 500mg tid po, Furazolidone 100 bid po for 7 days
Experimental: Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7) Vonoprazan Fumarate 20mg bid po Tetracycline 500mg tid po Furazolidone 100 bid po for 7 days	Drug: Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7) VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days

Outcome Measures

Primary Outcome Measures

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

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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xijing Hosipital of Digestive Disease	Xi'an	Shaanxi	China	710032

Sponsors and Collaborators

Xijing Hospital of Digestive Diseases

Investigators

Principal Investigator: Yongquan Shi, Xijing Hosipital of Digestive Disease

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yongquan Shi, Professor, Xijing Hospital of Digestive Diseases

ClinicalTrials.gov Identifier:

NCT05345210

Other Study ID Numbers:

XJLL-KY20222010

First Posted:

Apr 25, 2022

Last Update Posted:

Apr 25, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2022