Acotiamide vs Itopride in Postprandial Distress Syndrome

NCT07174297 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: GTZ-FD-012-25
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief Summary

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"

Conditions

Postprandial Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale in 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.

  8 weeks

Secondary Outcomes (3)

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

  8 weeks

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

  8 weeks

• Frequency of adverse events, serious adverse events and tolerability in both groups

  8 weeks

Study Arms (2)

assignment of participants to treatment group A (Acotiamide)

ACTIVE COMPARATOR

Drug: Acotiamide

assignment of participants to treatment group B (Itopride).

ACTIVE COMPARATOR

Drug: Acotiamide

Interventions

Acotiamide DRUG

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

Also known as: Itopride

assignment of participants to treatment group A (Acotiamide); assignment of participants to treatment group B (Itopride).

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Getz Pharma: lead
• Rawalpindi Medical College, Pakistan: collaborator

MeSH Terms

Interventions

Z 338; itopride

Study Officials

• Prof. Dr. Muahmmad Umar, MBBS, FCPS, FACG, AGAF, FRCP

  Rawalpindi Medical University/College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahaveer MR Maheshwari, MBBS

CONTACT

+923202521918; mahaveer.maheshwari@getzpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, comparative randomized, parallel, two-arms, multi-center study. A permuted block randomization technique was applied to generate an individual list of random assignment of participants to treatment group A (Acotiamide) and treatment group B (Itopride). A block represents a separate center/site of enrollment, and each center will enroll total 50 - 55 participants as per protocol. There will be total 3 recruitment centers, and each recruiting center will follow the provided list of random assignments (Annexure). An online software (https://www.sealedenvelope.com/simple-randomiser/v1/lists) was used to generate a random sequence for total 152 subjects with balanced distribution method.

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 15, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09