Acotiamide vs Itopride in Postprandial Distress Syndrome

Getz Pharma

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Postprandial Distress Syndrome

Treatments: Drug: Acotiamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07174297

GTZ-FD-012-25

Details and patient eligibility

About

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"

Full description

we are 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

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

Enrollment: 152 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

assignment of participants to treatment group A (Acotiamide)

Active Comparator group

Treatment:

Drug: Acotiamide

assignment of participants to treatment group B (Itopride).

Active Comparator group

Treatment:

Drug: Acotiamide