Postprandial Distress SyndromePhase 3NCT07174297
Acotiamide vs Itopride in Postprandial Distress Syndrome
A Phase 3 study testing Acotiamide in people with Postprandial Distress Syndrome, run by Getz Pharma.
Trial 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" Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postprandial Distress Syndrome
- What is being tested?
- Acotiamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2025to 30 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: To Compare the Efficacy and Safety of Acotiamide Versus Itopride in Patient With Post Prandial Distress Syndrome Type of Functional Dyspepsia
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"
Read the 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
- Conditions
- Postprandial Distress Syndrome
- Being tested
- Acotiamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcotiamideDrug
Also called Itopride
Both these drugs are used for the management of PDS type of FD
| Study group | Role | What they receive |
|---|---|---|
| assignment of participants to treatment group A (Acotiamide) | Active comparator | Not described Receives: Drug: Acotiamide |
| assignment of participants to treatment group B (Itopride). | Active comparator | Not described Receives: Drug: Acotiamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale in 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.
Measured: 8 weeks
Secondary outcomes (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
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.
Measured: 8 weeks
Difference between both groups in quality of life by using short form Nepean Dyspepsia Index scale
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
Measured: 8 weeks
Frequency of adverse events, serious adverse events and tolerability in both groups
Frequency of adverse events will be assessed through a patient diary maintained throughout the study, with entries reviewed at each visit
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start30 Oct 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Getz Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rawalpindi Medical College, Pakistan
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Muahmmad Umar, MBBS, FCPS, FACG, AGAF, FRCP, Principal investigator, Rawalpindi Medical University/College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174297
- Sponsor's protocol ID
- GTZ-FD-012-25
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: it will be decided after closing of enrollment
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Efficacy and Safety of Acotiamide Versus Itopride in Patient With Post Prandial Distress Syndrome Type of Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT07174297
- Acronym / sponsor ID
- GTZ-FD-012-25
- Conditions
- Postprandial Distress Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Getz PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Rawalpindi Medical College, Pakistan
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| assignment of participants to treatment group A (Acotiamide) | Active comparator | Drug: Acotiamide |
| assignment of participants to treatment group B (Itopride). | Active comparator | Drug: Acotiamide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcotiamideAlso: ItoprideBoth these drugs are used for the management of PDS type of FD | Drug | assignment of participants to treatment group A (Acotiamide), assignment of participants to treatment group B (Itopride). |
Primary outcome
Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale in 8 weeks
Time frame: 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.
3 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Undecided. it will be decided after closing of enrollment
Related trials for Postprandial Distress Syndrome
Enrolling by invitationObservational study
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Cognitive Behavioral Therapy for Functional Dyspepsia (Epigastric Pain Syndrome and Postprandial Distress Syndrome Subtypes)
Functional Dyspepsia, Epigastric Pain Syndrome
Not yet recruitingPhase 4
Comparing Acotiamide and Itopride for the Management of Indigestion
Functioanl Dyspepsia, Post Prandial Distress Syndrome
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A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome
Postprandial Distress Syndrome
Recruiting
Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Dr. Muahmmad Umar, MBBS, FCPS, FACG, AGAF, FRCP principal investigator
Rawalpindi Medical University/College
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acotiamide in people with Postprandial Distress Syndrome, run by Getz Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahaveer MR Maheshwari, MBBS (+923202521918, mahaveer.maheshwari@getzpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale in 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.