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Acotiamide vs Itopride in Postprandial Distress Syndrome

ConditionPostprandial Distress Syndrome
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGetz Pharma

About this trial

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"

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Acotiamide

    Drug

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

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: assignment of participants to treatment group A (Acotiamide)Active comparator 1 intervention
Group B: assignment of participants to treatment group B (Itopride).Active comparator 1 intervention

Trial outcomes

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.

Time frame
8 weeks

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

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.

Time frame
8 weeks
2

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

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

Time frame
8 weeks
3

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

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

Time frame
8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Getz Pharma

Lead sponsor

Rawalpindi Medical College, Pakistan

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: