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NOT YET RECRUITING
NCT07449689
PHASE4

Comparing Acotiamide and Itopride for the Management of Indigestion

Sponsor: Aga Khan University

View on ClinicalTrials.gov

Summary

This study is a randomized, double-blinded trial that will compare the effectiveness of two medications, acotiamide and itopride, in treating Functional Dyspepsia. Functional Dyspepsia causes uncomfortable symptoms arising from the gastro-duodenal region, such as fullness after meals, early satiation, stomach pain, and burning. The primary aim of this trial is to determine whether acotiamide is superior to itopride-specifically by a margin of 15%-at improving these meal-related digestive symptoms. Participants will be involved in the study for a total of 5 weeks. The study begins with a 7-day baseline period where participants will track their symptoms daily. Following the baseline period, participants will be randomly assigned to receive either 100mg of acotiamide three times a day or 50mg of itopride three times a day. The treatment phase will last for 4 weeks, during which participants will take the medication before meals on an empty stomach. Participants will continue to track their symptoms daily and will complete questionnaires about their overall treatment effect and quality of life at follow-up visits.

Official title: A Double-Blind Superiority Randomized Controlled Trial Comparing Acotiamide vs Itopride for Functional Dyspepsia Management

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

368

Start Date

2026-04

Completion Date

2027-05

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

DRUG

Acotiamide

100mg thrice daily, before meals on an empty stomach for 4 weeks.

DRUG

itopride

50mg thrice daily, before meals on an empty stomach for 4 weeks.