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
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
Treatments tested in this trial
- Acotiamide
Treatment groups
152 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Getz Pharma
Lead sponsor
Rawalpindi Medical College, Pakistan
Collaborator
Source ClinicalTrials.gov