NCT07174297

Acotiamide vs Itopride in Postprandial Distress Syndrome

To Compare the Efficacy and Safety of Acotiamide Versus Itopride in Patient With Post Prandial Distress Syndrome Type of Functional Dyspepsia

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Getz Pharma · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to "To compare the efficacy and safety of Acotiamide versus Itopride in patient with post prandial distress syndrome type of functional dyspepsia"

Detailed description

Investigator is aiming to conduct an Open-label, comparative randomized controlled, parallel, two-arms, multi-center study. Primary Outcomes: • Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale (LPDS) in 8 weeks from the baseline Secondary Outcomes: * Difference between both groups in symptoms of Postprandial Distress Syndrome (PDS) (including early satiety, abdominal bloating, postprandial fullness) by using Leuven Postprandial Distress Scale (LPDS) * Difference between both groups in quality of life by using short form Nepean Dyspepsia Index (SF-NDI) from baseline * Frequency of adverse events, serious adverse events and tolerability in both groups

Conditions

• Postprandial Distress Syndrome

Interventions

Type	Name	Description
DRUG	Acotiamide	Both these drugs are used for the management of PDS type of FD

Timeline

• Start date: 2025-10-30
• Primary completion: 2026-12-30
• Completion: 2027-04-30
• First posted: 2025-09-15
• Last updated: 2025-09-23

Regulatory

• FDA-regulated drug study