Functioanl DyspepsiaPhase 4NCT07449689
Comparing Acotiamide and Itopride for the Management of Indigestion
A Phase 4 study testing Acotiamide and itopride in people with Functioanl Dyspepsia and Post Prandial Distress Syndrome, run by Aga Khan University.
Trial summary
This study is a randomized, double-blinded trial that will compare the effectiveness of two medications, acotiamide and itopride, in treating Functional Dyspepsia. Functional Dyspepsia causes uncomfortable symptoms arising from the gastro-duodenal region, such as fullness after meals, early satiation, stomach pain… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functioanl Dyspepsia, Post Prandial Distress Syndrome
- What is being tested?
- Acotiamide and itopride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to May 2027
- Phase
- Phase 4
- 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
- Patients experiencing bothersome post-prandial fullness or bothersome early satiation at least three days a week.
- Symptom onset must have occurred six months prior to diagnosis, and symptoms must have been present for at least the past three months.
- No evidence of organic, systemic, or metabolic disease based on clinical investigations and endoscopy.
- Patients with co-existing symptoms of Epigastric Pain Syndrome (EPS) are included only if the symptoms causing the most distress are meal-related.
- Individuals who have already tested negative for H. pylori (separate tests will not be conducted for the study).
Who cannot join
- Patients with an identifiable organic disease that can explain their symptoms, such as peptic ulcer, GERD, or chronic pancreatitis.
- Patients with a history of gastrointestinal surgery.
- History of malignancy in the past five years.
- Patients having major psychiatric or depressive disorders.
- Patients with a history of drug or alcohol abuse.
- Patients with advanced chronic kidney disease.
Show all 13Show fewer
- Patients with uncontrolled diabetes (HbA1c >8).
- Patients with uncontrolled hypertension.
- Patients diagnosed with Irritable Bowel Syndrome.
- Pregnant or lactating women.
- Patients who have used antibiotics, opioids, or any other medication that -affects gastrointestinal function in the past 4 weeks.
- H. pylori positive patients.
- Patients who cannot fill out scales or record their symptoms.
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: A Double-Blind Superiority Randomized Controlled Trial Comparing Acotiamide vs Itopride for Functional Dyspepsia Management
This study is a randomized, double-blinded trial that will compare the effectiveness of two medications, acotiamide and itopride, in treating Functional Dyspepsia. Functional Dyspepsia causes uncomfortable symptoms arising from the gastro-duodenal region, such as fullness after meals, early satiation, stomach pain, and burning.
The primary aim of this trial is to determine whether acotiamide is superior to itopride-specifically by a margin of 15%-at improving these meal-related digestive symptoms.
Read more
Participants will be involved in the study for a total of 5 weeks. The study begins with a 7-day baseline period where participants will track their symptoms daily.
Following the baseline period, participants will be randomly assigned to receive either 100mg of acotiamide three times a day or 50mg of itopride three times a day.
The treatment phase will last for 4 weeks, during which participants will take the medication before meals on an empty stomach.
Participants will continue to track their symptoms daily and will complete questionnaires about their overall treatment effect and quality of life at follow-up visits.
Read the detailed description
Functional Dyspepsia (FD) is defined as gastro-duodenal symptoms occurring without any underlying systemic or metabolic disease, affecting an estimated 8.4% of the global population. Both acotiamide and itopride are established, commercially available medications known to be efficacious in managing FD. However, there is currently no direct comparison between the two drugs to help establish a universally accepted standard of care.
This study is designed as a single-center, randomized, double-blind superiority trial to be conducted at the Aga Khan University Hospital in Karachi, Pakistan. The trial seeks to enroll 368 participants aged 18 to 70 who meet the ROME IV criteria for FD, specifically Postprandial Distress Syndrome (PDS).
Methodology \& Procedures:
Baseline Phase: Participants will undergo a 7-day baseline period in which they will discontinue any current gastrointestinal medications to clear residual effects.
Randomization \& Blinding: Participants will be randomized via a computer-generated program in a 1:1 ratio to one of two treatment arms. To ensure double-blinding, the hospital pharmacy will encapsulate both acotiamide and itopride into identical opaque capsules, making them indistinguishable in taste, smell, and appearance.
Intervention: The active treatment phase lasts 4 weeks. Group 1 will self-administer 100mg of oral acotiamide thrice daily before meals, while Group 2 will self-administer 50mg of oral itopride thrice daily before meals.
Assessments:
Symptom Severity Diary: Participants will record nine specific symptoms daily on a scale of 0-3 throughout the 5-week study duration.
Overall Treatment Effect (OTE): At week 1 and week 4, participants will evaluate their symptom changes compared to baseline using a 7-point Likert scale.
Quality of Life (QoL): The Short form of NPEAN dyspepsia index (SF-NDI) will be administered at the end of the baseline period (day 7) and at the end of the treatment period (week 4) to assess changes in disease-specific QoL.
Safety Monitoring:
Participants will be monitored for Adverse Events (AE) and Serious Adverse Events (SAE) at the week 1 and week 4 follow-up visits.
All adverse events will be documented in case report forms and tracked by the Principal Investigator until resolution or stabilization, with SAEs being reported to the Ethical Review Committee.
- Being tested
- Acotiamide, itopride
- Keywords
- Functional Dyspepsia, Acotiamide, Itopride, Post-Prandial Distress Syndrome, Gastroprokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcotiamideDrug
100mg thrice daily, before meals on an empty stomach for 4 weeks.
itoprideDrug
50mg thrice daily, before meals on an empty stomach for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acotiamide Arm | Experimental | Participants randomized to this group will receive 100 mg of acotiamide thrice daily, before meals on an empty stomach for 4 weeks. Receives: Drug: Acotiamide |
| Itopride Arm | Active comparator | Participants randomized to this group will receive 50 mg of itopride thrice daily, before meals on an empty stomach for 4 weeks. Receives: Drug: itopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
: Overall Treatment Effect (OTE)
The primary outcome is evaluated using the Overall Treatment Effect (OTE) questionnaire to determine if acotiamide is superior to itopride in improving symptoms of functional dyspepsia. Participants will be asked to compare their current symptoms to their baseline using a 7-point Likert scale. The scale ranges from a minimum value of 1, which denotes "extremely improved compared to baseline," to a maximum value of 7, which denotes "extremely aggravated compared to baseline". Therefore, higher scores on this scale indicate a worse outcome. Patients selecting options 1 through 3 on the OTE scale will be considered responders to the treatment, while those selecting 4 through 7 will be considered non-responders.
Measured: Week 1 and Week 4.
Secondary outcomes (2)
Quality of Life: Assessing changes in the patient's disease-specific quality of life.
Quality of Life is assessed to measure changes in the patient's disease-specific quality of life. This is measured using the unabbreviated Short form of the Nepean Dyspepsia Index (SF-NDI). The SF-NDI evaluates 5 subscales: tension, daily activity, eating/drinking, knowledge/control, and work/study. The scale for this index ranges from a minimum value of 1 to a maximum value of 5. On this scale, a lower score indicates a better quality of life, meaning that a higher score represents a worse outcome.
Measured: Recorded on day 7 (end of baseline) and at the end of week 4
Symptom Severity: Participants will evaluate the severity of 9 specific upper gastrointestinal symptoms
Symptom severity is assessed by having participants evaluate 9 specific upper gastrointestinal symptoms: upper abdominal pain, post prandial fullness, upper abdominal discomfort, bloating, early satiation, excessive belching, nausea, vomiting, and heartburn. This is measured daily using the unabbreviated Symptom Severity Diary scale. The scale ranges from a minimum value of 0 to a maximum value of 3 for each individual symptom. On this scale, a higher score indicates greater symptom severity, meaning that a higher score represents a worse outcome.
Measured: Throughout the 4-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Functioanl DyspepsiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following a 7-day baseline period, eligible participants will be randomized into two parallel treatment arms to receive either Acotiamide (100mg) or Itopride (50mg) three times a day for exactly 4 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Searle Company Limited Pakistan
- Responsible party
- Principal investigator, SHAHAB ABID, Aga Khan University
- Investigators
- Shahab Abid, MBBS, FCPS, FRCP, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449689
- Sponsor's protocol ID
- 2025-11202-35841
- Other IDs
- 2025
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang X, Lv B, Zhang S, Fan YH, Meng LN. Itopride therapy for functional dyspepsia: a meta-analysis. World J Gastroenterol. 2012 Dec 28;18(48):7371-7. doi: 10.3748/wjg.v18.i48.7371.
PubMed 23326147Tack J, Masclee A, Heading R, Berstad A, Piessevaux H, Popiela T, Vandenberghe A, Kato H. A dose-ranging, placebo-controlled, pilot trial of Acotiamide in patients with functional dyspepsia. Neurogastroenterol Motil. 2009 Mar;21(3):272-80. doi: 10.1111/j.1365-2982.2009.01261.x.
PubMed 19254354Xiao M, Ying J, Zhao Y, Zhao Y, Liu Y, Lu F. Developing a Scale for the Evaluation of People With Post-prandial Distress Syndrome. Front Public Health. 2021 Jun 29;9:695809. doi: 10.3389/fpubh.2021.695809. eCollection 2021.
PubMed 34268292Ang D, Talley NJ, Simren M, Janssen P, Boeckxstaens G, Tack J. Review article: endpoints used in functional dyspepsia drug therapy trials. Aliment Pharmacol Ther. 2011 Mar;33(6):634-49. doi: 10.1111/j.1365-2036.2010.04566.x. Epub 2011 Jan 12.
PubMed 21223343
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Superiority Randomized Controlled Trial Comparing Acotiamide vs Itopride for Functional Dyspepsia Management
- ClinicalTrials.gov ID
- NCT07449689
- Acronym / sponsor ID
- 2025-11202-35841
- Keywords
- Functional Dyspepsia, Acotiamide, Itopride, Post-Prandial Distress Syndrome, Gastroprokinetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- The Searle Company Limited Pakistan
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Mar 2026 (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.
This study is a randomized, double-blinded trial that will compare the effectiveness of two medications, acotiamide and itopride, in treating Functional Dyspepsia. Functional Dyspepsia causes uncomfortable symptoms arising from the gastro-duodenal region, such as fullness after meals, early satiation, stomach pain, and burning.
The primary aim of this trial is to determine whether acotiamide is superior to itopride-specifically by a margin of 15%-at improving these meal-related digestive symptoms.
Participants will be involved in the study for a total of 5 weeks. The study begins with a 7-day baseline period where participants will track their symptoms daily.
Following the baseline period, participants will be randomly assigned to receive either 100mg of acotiamide three times a day or 50mg of itopride three times a day.
The treatment phase will last for 4 weeks, during which participants will take the medication before meals on an empty stomach.
Participants will continue to track their symptoms daily and will complete questionnaires about their overall treatment effect and quality of life at follow-up visits.
Detailed description
Functional Dyspepsia (FD) is defined as gastro-duodenal symptoms occurring without any underlying systemic or metabolic disease, affecting an estimated 8.4% of the global population. Both acotiamide and itopride are established, commercially available medications known to be efficacious in managing FD. However, there is currently no direct comparison between the two drugs to help establish a universally accepted standard of care.
This study is designed as a single-center, randomized, double-blind superiority trial to be conducted at the Aga Khan University Hospital in Karachi, Pakistan. The trial seeks to enroll 368 participants aged 18 to 70 who meet the ROME IV criteria for FD, specifically Postprandial Distress Syndrome (PDS).
Methodology \& Procedures:
Baseline Phase: Participants will undergo a 7-day baseline period in which they will discontinue any current gastrointestinal medications to clear residual effects.
Randomization \& Blinding: Participants will be randomized via a computer-generated program in a 1:1 ratio to one of two treatment arms. To ensure double-blinding, the hospital pharmacy will encapsulate both acotiamide and itopride into identical opaque capsules, making them indistinguishable in taste, smell, and appearance.
Intervention: The active treatment phase lasts 4 weeks. Group 1 will self-administer 100mg of oral acotiamide thrice daily before meals, while Group 2 will self-administer 50mg of oral itopride thrice daily before meals.
Assessments:
Symptom Severity Diary: Participants will record nine specific symptoms daily on a scale of 0-3 throughout the 5-week study duration.
Overall Treatment Effect (OTE): At week 1 and week 4, participants will evaluate their symptom changes compared to baseline using a 7-point Likert scale.
Quality of Life (QoL): The Short form of NPEAN dyspepsia index (SF-NDI) will be administered at the end of the baseline period (day 7) and at the end of the treatment period (week 4) to assess changes in disease-specific QoL.
Safety Monitoring:
Participants will be monitored for Adverse Events (AE) and Serious Adverse Events (SAE) at the week 1 and week 4 follow-up visits.
All adverse events will be documented in case report forms and tracked by the Principal Investigator until resolution or stabilization, with SAEs being reported to the Ethical Review Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Following a 7-day baseline period, eligible participants will be randomized into two parallel treatment arms to receive either Acotiamide (100mg) or Itopride (50mg) three times a day for exactly 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Acotiamide Arm | Experimental | Drug: AcotiamideParticipants randomized to this group will receive 100 mg of acotiamide thrice daily, before meals on an empty stomach for 4 weeks. |
| Itopride Arm | Active comparator | Drug: itoprideParticipants randomized to this group will receive 50 mg of itopride thrice daily, before meals on an empty stomach for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients experiencing bothersome post-prandial fullness or bothersome early satiation at least three days a week.
- Symptom onset must have occurred six months prior to diagnosis, and symptoms must have been present for at least the past three months.
- No evidence of organic, systemic, or metabolic disease based on clinical investigations and endoscopy.
- Patients with co-existing symptoms of Epigastric Pain Syndrome (EPS) are included only if the symptoms causing the most distress are meal-related.
- Individuals who have already tested negative for H. pylori (separate tests will not be conducted for the study).
Key exclusion criteria (13 listed)
- Patients with an identifiable organic disease that can explain their symptoms, such as peptic ulcer, GERD, or chronic pancreatitis.
- Patients with a history of gastrointestinal surgery.
- History of malignancy in the past five years.
- Patients having major psychiatric or depressive disorders.
- Patients with a history of drug or alcohol abuse.
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 |
|---|---|---|
| Acotiamide100mg thrice daily, before meals on an empty stomach for 4 weeks. | Drug | Acotiamide Arm |
| itopride50mg thrice daily, before meals on an empty stomach for 4 weeks. | Drug | Itopride Arm |
Primary outcome
: Overall Treatment Effect (OTE)
Time frame: Week 1 and Week 4.
The primary outcome is evaluated using the Overall Treatment Effect (OTE) questionnaire to determine if acotiamide is superior to itopride in improving symptoms of functional dyspepsia. Participants will be asked to compare their current symptoms to their baseline using a 7-point Likert scale. The scale ranges from a minimum value of 1, which denotes "extremely improved compared to baseline," to a maximum value of 7, which denotes "extremely aggravated compared to baseline". Therefore, higher scores on this scale indicate a worse outcome. Patients selecting options 1 through 3 on the OTE scale will be considered responders to the treatment, while those selecting 4 through 7 will be considered non-responders.
2 secondary outcomes
Quality of Life: Assessing changes in the patient's disease-specific quality of life.
Time frame: Recorded on day 7 (end of baseline) and at the end of week 4
Symptom Severity: Participants will evaluate the severity of 9 specific upper gastrointestinal symptoms
Time frame: Throughout the 4-week period
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 6 Mar 2026.
- Background: PubMed 23326147Huang X, Lv B, Zhang S, Fan YH, Meng LN. Itopride therapy for functional dyspepsia: a meta-analysis. World J Gastroenterol. 2012 Dec 28;18(48):7371-7. doi: 10.3748/wjg.v18.i48.7371.
- Background: PubMed 19254354Tack J, Masclee A, Heading R, Berstad A, Piessevaux H, Popiela T, Vandenberghe A, Kato H. A dose-ranging, placebo-controlled, pilot trial of Acotiamide in patients with functional dyspepsia. Neurogastroenterol Motil. 2009 Mar;21(3):272-80. doi: 10.1111/j.1365-2982.2009.01261.x.
- Background: PubMed 34268292Xiao M, Ying J, Zhao Y, Zhao Y, Liu Y, Lu F. Developing a Scale for the Evaluation of People With Post-prandial Distress Syndrome. Front Public Health. 2021 Jun 29;9:695809. doi: 10.3389/fpubh.2021.695809. eCollection 2021.
- Background: PubMed 21223343Ang D, Talley NJ, Simren M, Janssen P, Boeckxstaens G, Tack J. Review article: endpoints used in functional dyspepsia drug therapy trials. Aliment Pharmacol Ther. 2011 Mar;33(6):634-49. doi: 10.1111/j.1365-2036.2010.04566.x. Epub 2011 Jan 12.
- Individual participant dataSharing planned: No
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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.
Shahab Abid, MBBS, FCPS, FRCP, PhD principal investigator
Aga Khan University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acotiamide and itopride in people with Functioanl Dyspepsia and Post Prandial Distress Syndrome, run by Aga Khan University.
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 13 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 6 Mar 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Shahab Abid (+923333965940, shahab.abid@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
: Overall Treatment Effect (OTE) (time frame: Week 1 and Week 4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07449689, which also lists 4 linked publications.
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 6 Mar 2026.