Acotiamide vs Itopride in Postprandial Distress Syndrome
- Conditions
- Postprandial Distress Syndrome
- Interventions
- Registration Number
- NCT07174297
- Lead Sponsor
- Getz Pharma
- 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 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 152
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description assignment of participants to treatment group A (Acotiamide) Acotiamide - assignment of participants to treatment group B (Itopride). Acotiamide -
- Primary Outcome Measures
Name Time Method Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale in 8 weeks 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.
- Secondary Outcome Measures
Name Time Method Difference between both groups in symptoms of Postprandial Distress Syndrome (PDS) (including early satiety, abdominal bloating, postprandial fullness) by using Leuven Postprandial Distress Scale 8 weeks 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.
Difference between both groups in quality of life by using short form Nepean Dyspepsia Index scale 8 weeks 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
Frequency of adverse events, serious adverse events and tolerability in both groups 8 weeks Frequency of adverse events will be assessed through a patient diary maintained throughout the study, with entries reviewed at each visit