Comparing Acotiamide and Itopride for the Management of Indigestion

March 5, 2026 updated by: SHAHAB ABID, Aga Khan University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

368

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Patients experiencing bothersome post-prandial fullness or bothersome early satiation at least three days a week.
  • Symptom onset must have occurred six months prior to diagnosis, and symptoms must have been present for at least the past three months.
  • No evidence of organic, systemic, or metabolic disease based on clinical investigations and endoscopy.
  • Patients with co-existing symptoms of Epigastric Pain Syndrome (EPS) are included only if the symptoms causing the most distress are meal-related.
  • Individuals who have already tested negative for H. pylori (separate tests will not be conducted for the study).

Exclusion Criteria

  • Patients with an identifiable organic disease that can explain their symptoms, such as peptic ulcer, GERD, or chronic pancreatitis.
  • Patients with a history of gastrointestinal surgery.
  • History of malignancy in the past five years.
  • Patients having major psychiatric or depressive disorders.
  • Patients with a history of drug or alcohol abuse.
  • Patients with advanced chronic kidney disease.
  • Patients with uncontrolled diabetes (HbA1c >8).
  • Patients with uncontrolled hypertension.
  • Patients diagnosed with Irritable Bowel Syndrome.
  • Pregnant or lactating women.
  • Patients who have used antibiotics, opioids, or any other medication that -affects gastrointestinal function in the past 4 weeks.
  • H. pylori positive patients.
  • Patients who cannot fill out scales or record their symptoms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acotiamide Arm
Participants randomized to this group will receive 100 mg of acotiamide thrice daily, before meals on an empty stomach for 4 weeks.
Drug: Acotiamide
100mg thrice daily, before meals on an empty stomach for 4 weeks.
Active Comparator: Itopride Arm
Participants randomized to this group will receive 50 mg of itopride 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
: Overall Treatment Effect (OTE)
Time Frame: Week 1 and Week 4.
The primary outcome is evaluated using the Overall Treatment Effect (OTE) questionnaire to determine if acotiamide is superior to itopride in improving symptoms of functional dyspepsia. Participants will be asked to compare their current symptoms to their baseline using a 7-point Likert scale. The scale ranges from a minimum value of 1, which denotes "extremely improved compared to baseline," to a maximum value of 7, which denotes "extremely aggravated compared to baseline". Therefore, higher scores on this scale indicate a worse outcome. Patients selecting options 1 through 3 on the OTE scale will be considered responders to the treatment, while those selecting 4 through 7 will be considered non-responders.
Week 1 and Week 4.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life: Assessing changes in the patient's disease-specific quality of life.
Time Frame: Recorded on day 7 (end of baseline) and at the end of week 4
Quality of Life is assessed to measure changes in the patient's disease-specific quality of life. This is measured using the unabbreviated Short form of the Nepean Dyspepsia Index (SF-NDI). The SF-NDI evaluates 5 subscales: tension, daily activity, eating/drinking, knowledge/control, and work/study. The scale for this index ranges from a minimum value of 1 to a maximum value of 5. On this scale, a lower score indicates a better quality of life, meaning that a higher score represents a worse outcome.
Recorded on day 7 (end of baseline) and at the end of week 4
Symptom Severity: Participants will evaluate the severity of 9 specific upper gastrointestinal symptoms
Time Frame: Throughout the 4-week period
Symptom severity is assessed by having participants evaluate 9 specific upper gastrointestinal symptoms: upper abdominal pain, post prandial fullness, upper abdominal discomfort, bloating, early satiation, excessive belching, nausea, vomiting, and heartburn. This is measured daily using the unabbreviated Symptom Severity Diary scale. The scale ranges from a minimum value of 0 to a maximum value of 3 for each individual symptom. On this scale, a higher score indicates greater symptom severity, meaning that a higher score represents a worse outcome.
Throughout the 4-week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

The Searle Company Limited Pakistan

Investigators

  • Principal Investigator: Shahab Abid, MBBS, FCPS, FRCP, PhD, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-11202-35841

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Prandial Distress Syndrome

Clinical Trials on Acotiamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe