Acotiamide vs Itopride in Postprandial Distress Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-30

Study Completion Date

2027-04-30

Brief Summary

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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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Detailed Description

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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

Conditions

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Postprandial Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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assignment of participants to treatment group A (Acotiamide)

Group Type ACTIVE_COMPARATOR

Acotiamide

Intervention Type DRUG

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

assignment of participants to treatment group B (Itopride).

Group Type ACTIVE_COMPARATOR

Acotiamide

Intervention Type DRUG

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

Interventions

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Acotiamide

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

Intervention Type DRUG

Other Intervention Names

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Itopride

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No