Acotiamide vs Itopride in Postprandial Distress Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acotiamide.
- Who it may be relevant to
- Registry conditions: Postprandial Distress Syndrome. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
To Compare the Efficacy and Safety of Acotiamide Versus Itopride in Patient With Post Prandial Distress Syndrome Type of Functional Dyspepsia
Overview
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 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
Interventions
- Drug Acotiamide
Both these drugs are used for the management of PDS type of FD
Primary outcome measures
- Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale in 8 weeks [Time frame: 8 weeks]
Secondary outcome measures (3)
- Difference between both groups in symptoms of Postprandial Distress Syndrome (PDS) (including early satiety, abdominal bloating, postprandial fullness) by using Leuven Postprandial Distress Scale [Time frame: 8 weeks]
- Difference between both groups in quality of life by using short form Nepean Dyspepsia Index scale [Time frame: 8 weeks]
- Frequency of adverse events, serious adverse events and tolerability in both groups [Time frame: 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07174297 · GTZ-FD-012-25