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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05345210
Other study ID # XJLL-KY20222010
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 25, 2022
Est. completion date March 31, 2023

Study information

Verified date October 2022
Source Xijing Hospital of Digestive Diseases
Contact Jiaqiang Dong
Phone 86-029-84771506
Email dongjiaqiang1988@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date March 31, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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
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
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
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
Vonoprazan Fumarate+Tetracycline+Furazolidone 7days (VTF7)
VAC-14d:Vonoprazan Fumarate 20mg bid po, Amoxycillin 1000mg bid po, Clarithromycin 500mg bid po for 14 days

Locations

Country Name City State
China Xijing Hosipital of Digestive Disease Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Helicobacter Pylori eradication rate 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 28 days after treatment
Secondary symptoms effective rates 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 14 days of treatment, and 28 days after treatment
Secondary adverse events 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. 14 days of treatment, and 28 days after treatment
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