Skip to content

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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230504003
Enrollment
60
Registered
2023-05-04
Start date
2023-05-08
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proton Pump Inhibitor Refractory Functional Dyspepsia patients Functional dyspepsia, Vonoprazan, Global Overall Symptom scale, Nepean Dyspepsia Index, Hospital Anxiety and Depression scale

Interventions

The participant will receive Vonoprazan 20 mg per day for 28 days,The participant will receive Vonoprazan 10 mg per day for 28 days
Experimental Drug,Experimental Drug
Vonoprazan 20 mg,Vonoprazan 10 mg

Sponsors

Rajavithi Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Functional Dyspepsia Symptoms at 2 weeks and 4 weeks after received the intervention Global Overall Symptom Scale

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactPantaree Jaigla

Rajavithi Hospital

pantry_04@hotmail.com0871376670

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026