Status:
NOT_YET_RECRUITING
Acotiamide vs Itopride in Postprandial Distress Syndrome
Lead Sponsor:
Getz Pharma
Collaborating Sponsors:
Rawalpindi Medical College, Pakistan
Conditions:
Postprandial Distress Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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"
Detailed Description
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 gr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT07174297
Start Date
October 30 2025
End Date
April 30 2027
Last Update
September 23 2025
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