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NCT Number: NCT07174297

Acotiamide vs Itopride in Postprandial Distress Syndrome

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"

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Key information

Conditions

Postprandial Distress Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects to provide written informed consent prior to any study procedures being performed
  • Subjects with age 18-70 both male and female
  • Diagnosed with FD (PDS) by using ROME IV criteria
  • Subjects naive to acotiamide and Itopride for last 2 weeks
  • Subjects must have a normal endoscopy result within the 6 months

Exclusion criteria

  • Without predominant symptoms of ulcer and GERD based on history & endoscopy, IBS based on history & Rome IV criteria and Chronic idiopathic nausea based on history only
  • Subjects taking drugs that affect gut motility, gut sensitivity, SSRI and/or acid secretion who are unable to discontinue these drugs before initiating the intervention
  • Subjects with chronic medical disorders potentially contributing to PDS such as chronic pancreatitis, hypothyroidism, CKD and CLD identified through clinical history, physical examination, or previous medical records
  • Subjects with Type I or Type II diabetes
  • Pregnant & lactating mothers

Treatment and study plan

Acotiamide

Drug

Both these drugs are used for the management of PDS type of FD

Other names: Itopride

Primary outcomes

  1. Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale in 8 weeks

    Time frame: 8 weeks

    Overall treatment effect will be assessed using the Leeds Postprandial Distress Scale, with change in total score from baseline before initiation of treatment end of treatment. The decreased score representing the treatment response.

Secondary outcomes

  1. Difference between both groups in symptoms of Postprandial Distress Syndrome (PDS) (including early satiety, abdominal bloating, postprandial fullness) by using Leuven Postprandial Distress Scale

    Time frame: 8 weeks

    All the symptoms of PDDS will be assessed by using the Leeds Postprandial Distress Scale (LPDS), with change in total score from baseline before treatment initiation to end of treatment going downwards representing the treatment response.

  2. Difference between both groups in quality of life by using short form Nepean Dyspepsia Index scale

    Time frame: 8 weeks

    Quality of life will be assessed using the Nepean Dyspepsia Index, defined as the change in total score from baseline to the end of the treatment with lower scores indicating improvement

  3. Frequency of adverse events, serious adverse events and tolerability in both groups

    Time frame: 8 weeks

    Frequency of adverse events will be assessed through a patient diary maintained throughout the study, with entries reviewed at each visit

Study contacts

Contact information is provided by the study sponsor or research team.

Mahaveer MR Maheshwari, MBBS

CONTACT

[email protected]

+923202521918

Sponsors and collaborators

Lead sponsor

Getz Pharma

Industry

Collaborators

  • Rawalpindi Medical College, Pakistan

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 15, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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