MedPath

Efficacy of Vonoprazan for treatment functional dyspepsia

Phase 1
Completed
Conditions
dyspepsia&#44
vonoprazan
Registration Number
TCTR20201214004
Lead Sponsor
Gastroenterological Association of Thailand
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
89
Inclusion Criteria

1.Functional dyspepsia (ROME IV criteria)
2.Informed consent form

Exclusion Criteria

1. History of Helicobacter pylori infection
2. GI malignancy
3. Gastrectomy
4. HIV infection
5. Immunocompromised patients with on immunosuppression
6. Atazanavir, Rilpivirine, NSAIDs, Antiplatelet, Anticoagulant
7. Cirrhotic patients
8. Abnormal renal function (GFR < 30 )
9. Allery to omeprazole or vonoprazan
10. Drug abuses
11. Pregnant and lactation
12. withdrawl from research

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
efficacy in treatment dyspepsia 4 weeks Severity of Dyspepsia Assessment score
Secondary Outcome Measures
NameTimeMethod
quality of life 4 weeks Short form Nepean dyspepsia index,adverse events 4 weeks numbers of events
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