NCT07449689

Comparing Acotiamide and Itopride for the Management of Indigestion

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 368 (estimated)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Functional Dyspepsia (FD) is defined as gastro-duodenal symptoms occurring without any underlying systemic or metabolic disease, affecting an estimated 8.4% of the global population. Both acotiamide and itopride are established, commercially available medications known to be efficacious in managing FD. However, there is currently no direct comparison between the two drugs to help establish a universally accepted standard of care. This study is designed as a single-center, randomized, double-blind superiority trial to be conducted at the Aga Khan University Hospital in Karachi, Pakistan. The trial seeks to enroll 368 participants aged 18 to 70 who meet the ROME IV criteria for FD, specifically Postprandial Distress Syndrome (PDS). Methodology \& Procedures: Baseline Phase: Participants will undergo a 7-day baseline period in which they will discontinue any current gastrointestinal medications to clear residual effects. Randomization \& Blinding: Participants will be randomized via a computer-generated program in a 1:1 ratio to one of two treatment arms. To ensure double-blinding, the hospital pharmacy will encapsulate both acotiamide and itopride into identical opaque capsules, making them indistinguishable in taste, smell, and appearance. Intervention: The active treatment phase lasts 4 weeks. Group 1 will self-administer 100mg of oral acotiamide thrice daily before meals, while Group 2 will self-administer 50mg of oral itopride thrice daily before meals. Assessments: Symptom Severity Diary: Participants will record nine specific symptoms daily on a scale of 0-3 throughout the 5-week study duration. Overall Treatment Effect (OTE): At week 1 and week 4, participants will evaluate their symptom changes compared to baseline using a 7-point Likert scale. Quality of Life (QoL): The Short form of NPEAN dyspepsia index (SF-NDI) will be administered at the end of the baseline period (day 7) and at the end of the treatment period (week 4) to assess changes in disease-specific QoL. Safety Monitoring: Participants will be monitored for Adverse Events (AE) and Serious Adverse Events (SAE) at the week 1 and week 4 follow-up visits. All adverse events will be documented in case report forms and tracked by the Principal Investigator until resolution or stabilization, with SAEs being reported to the Ethical Review Committee.

Conditions

• Functioanl Dyspepsia
• Post Prandial Distress Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2026-03-04
• Last updated: 2026-03-06