Efficacy of Vonoprazan 10 mg compared with 20 mg for the initial treatment in patients with Proton Pump Inhibitor-Refractory Functional Dyspepsia: A Pilot Study
Phase 3
- Conditions
- Proton Pump Inhibitor Refractory Functional DyspepsiapatientsFunctional dyspepsia, Vonoprazan, Global Overall Symptom scale, Nepean Dyspepsia Index, Hospital Anxiety and Depression scale
- Registration Number
- TCTR20230504003
- Lead Sponsor
- Rajavithi Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Age greater than 18 years old,
2.Diagnosed functional dyspepsia by ROME IV criteria with persistent symptoms after four-week duration of standard dose Proton Pump Inhibitor,
3.No significant Gastroduodenal lesions such as no gastric ulcer, no duodenal ulcer and no gastroduodenal neoplasm by Esophagogastroduodenoscopy
4.Negative for H.pylori test for at least 3 months
Exclusion Criteria
1. Severe or uncontrolled co-morbidities such as chronic liver disease, end stage renal disease, chronic lungs disease, heart disease and cancer
2. On pregnancy or on lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional Dyspepsia Symptoms at 2 weeks and 4 weeks after received the intervention Global Overall Symptom Scale
- Secondary Outcome Measures
Name Time Method Functional Dyspepsia Quality of Life at 2 weeks and 4 weeks after received the intervention The Short form Nepean Dyspepsia Index,Frequency of rescue medication at 2 weeks and 4 weeks after received the intervention Patient reported outcome using a questionnaire interview,Safety and adverse events at 2 weeks and 4 weeks after received the intervention Patient reported outcome using a questionnaire interview