Comparing Acotiamide and Itopride for the Management of Indigestion

NCT07449689 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2025-11202-35841
• Study Type: interventional
• Target: 368
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Functioanl Dyspepsia; Post Prandial Distress Syndrome

Keywords

Functional Dyspepsia; Acotiamide; Itopride; Post-Prandial Distress Syndrome; Gastroprokinetic

Outcome Measures

Primary Outcomes (1)

• : Overall Treatment Effect (OTE)

  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 Outcomes (2)

• Quality of Life: Assessing changes in the patient's disease-specific quality of life.

  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

  Throughout the 4-week period

Study Arms (2)

Acotiamide Arm

EXPERIMENTAL

Participants randomized to this group will receive 100 mg of acotiamide thrice daily, before meals on an empty stomach for 4 weeks.

Drug: Acotiamide

Itopride Arm

ACTIVE COMPARATOR

Participants randomized to this group will receive 50 mg of itopride thrice daily, before meals on an empty stomach for 4 weeks.

Drug: itopride

Interventions

Acotiamide DRUG

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

Acotiamide Arm

itopride DRUG

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

Itopride Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead
• The Searle Company Limited Pakistan: collaborator

Related Publications (4)

• Huang X, Lv B, Zhang S, Fan YH, Meng LN. Itopride therapy for functional dyspepsia: a meta-analysis. World J Gastroenterol. 2012 Dec 28;18(48):7371-7. doi: 10.3748/wjg.v18.i48.7371.

  PMID: 23326147 BACKGROUND

• Tack J, Masclee A, Heading R, Berstad A, Piessevaux H, Popiela T, Vandenberghe A, Kato H. A dose-ranging, placebo-controlled, pilot trial of Acotiamide in patients with functional dyspepsia. Neurogastroenterol Motil. 2009 Mar;21(3):272-80. doi: 10.1111/j.1365-2982.2009.01261.x.

  PMID: 19254354 BACKGROUND

• Xiao M, Ying J, Zhao Y, Zhao Y, Liu Y, Lu F. Developing a Scale for the Evaluation of People With Post-prandial Distress Syndrome. Front Public Health. 2021 Jun 29;9:695809. doi: 10.3389/fpubh.2021.695809. eCollection 2021.

  PMID: 34268292 BACKGROUND

• Ang D, Talley NJ, Simren M, Janssen P, Boeckxstaens G, Tack J. Review article: endpoints used in functional dyspepsia drug therapy trials. Aliment Pharmacol Ther. 2011 Mar;33(6):634-49. doi: 10.1111/j.1365-2036.2010.04566.x. Epub 2011 Jan 12.

  PMID: 21223343 BACKGROUND

MeSH Terms

Interventions

Z 338; itopride

Study Officials

• Shahab Abid, MBBS, FCPS, FRCP, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahab Abid

CONTACT

+923333965940; shahab.abid@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Gastroenterology)

Model Details: Following a 7-day baseline period, eligible participants will be randomized into two parallel treatment arms to receive either Acotiamide (100mg) or Itopride (50mg) three times a day for exactly 4 weeks.

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share