Postprandial Distress Syndrome
Conditions
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
Interventions
DRUGAcotiamide
Both these drugs are used for the management of PDS type of FD
Sponsors
Rawalpindi Medical College, Pakistan
Getz Pharma
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, comparative randomized, parallel, two-arms, multi-center study. A permuted block randomization technique was applied to generate an individual list of random assignment of participants to treatment group A (Acotiamide) and treatment group B (Itopride). A block represents a separate center/site of enrollment, and each center will enroll total 50 - 55 participants as per protocol. There will be total 3 recruitment centers, and each recruiting center will follow the provided list of random assignments (Annexure). An online software (https://www.sealedenvelope.com/simple-randomiser/v1/lists) was used to generate a random sequence for total 152 subjects with balanced distribution method.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactMahaveer MR Maheshwari, MBBS
Outcome results
None listed