Enteral Feeding IntolerancePhase 3NCT06826443
A Comparative Evaluation of Mosapride Versus Metoclopramide for Enteral Feeding Intolerance in Critically Ill Patients
A Phase 3 study testing Mosapride Citrate Tablets and Metoclopramide 10mg in people with Enteral Feeding Intolerance, run by Ain Shams University at 1 site in Egypt.
Trial summary
Caring for critically ill patients in an intensive care unit (ICU) is considered a standard of care. According to the Society of Critical Care Medicine (SCCM), as a function of the complex nature of the care provided in the ICU, the ideal method to provide support to the critically ill involves the participation of a… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Enteral Feeding Intolerance
- What is being tested?
- Mosapride Citrate Tablets and Metoclopramide 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2025to May 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aging between 18 and 60 years (of both sexes)
- Patients admitted to the ICU and are expected to stay in the ICU for not less than 7 days
- Patients prescribed enteral feeding.
Who cannot join
- The following patients are
- Age less than 18 years or more than 60 years.
- Patients who had previous upper gastrointestinal tract surgery, obstruction, hemorrhage or history of GI disease.
- Patients who are clinically significant hepatic dysfunction. (>3 times above the upper end of normal range of bilirubin, γ-glutamyl transferase, aspartate transaminase, or lactate dehydrogenase)
- Patients who are on regular use of H2 blockers, prokinetic, proton pump inhibitor or anticholinergic agents for previous 4 weeks.
- Patients with arrhythmia or atrioventricular blocks.
- Patients with any condition or comorbid disease that might interfere with gastric emptying such as diabetes.
- Patients with head injuries.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Matarya Teaching Hospital
Cairo
Amir Iskander Fellow in the Critical Care Department - Matareya Teaching Hos, +201227933624, amireskanderhanna@gmail.com
Amir Fellow in the Critical Care Department - Matareya Teaching Hos, MD of medicine
About this study
Caring for critically ill patients in an intensive care unit (ICU) is considered a standard of care. According to the Society of Critical Care Medicine (SCCM), as a function of the complex nature of the care provided in the ICU, the ideal method to provide support to the critically ill involves the participation of a multi-professional staff.
Provision of nutrition support to the critically ill is now established as an essential part of patient care where aiming toward 100% of the predicted target may have resulted in reduced mortality and increased ventilator-free days in those who are premorbid malnourished. Despite these reported benefits, clinicians continue to deliver little more than half of the enteral nutrition (EN) they plan to provide, due to gastric motility disorders, patient intolerance and clinical interruptions. Also despite the availability of numerous clinical practice guidelines (CPGs) focused on feeding critically ill patients, observational studies have consistently demonstrated persistent and significant gaps between guideline recommendations and actual nutrition practice. Consequently, underfeeding is prevalent in the intensive care unit (ICU), with patients on average receiving only 60 % of the calories that are prescribed. Moreover, Among the barriers to adequate nutritional supply in the ICU which contributes to nutritional status deterioration, gastrointestinal disorders causing enteral feed intolerance are the most important and the most often mentioned in the literature. when gastric emptying was measured in critically ill patients, 46 % of them had evidence of delayed gastric emptying. Untreated slow gastric emptying has a plethora of clinical consequences such as vomiting, aspiration of gastric contents, pneumonia, and contributes significantly to the frequent interruptions and cessation of EN in the ICU, which results in inadequate nutritional delivery. Studies have shown an association between feeding intolerance, prolonged intensive care unit (ICU) stay, and increased risk of death.
Read more
Guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patients has demonstrated the importance of the use of prokinetic drugs to improve tolerance to gastric feeding in critically ill patients and achieve earlier discharge.
Prokinetic drugs act by promoting gastric motility, increase gastric emptying, prevent the retention and reflux of gastric contents and thus provide symptomatic relief.
Most of the prokinetic drugs are efficacious with prokinetic activity but the matter of major concern is their side effect profile. The most commonly used agent is metoclopramide. Although it is the most commonly used prokinetic to treat delayed gastric emptying and facilitate early enteral feeding, adverse complications limit its use including tachyphylaxis, tardive dyskinesia on long term use and QT prolongation predisposing to cardiac arrhythmias. Several drug targets have been identified to develop new promotility agents and several new medications are under investigation to overcome the side effects caused by most of the prokinetics .
Mosapride is another available prokinetic agent that enhances gastric motility through serotonin receptor agonism; resulting in prokinetic effects. It accelerates gastric emptying, improves gastric tension and sensitivity, and has anti-emetic action.
The aim of the current study is to compare the effectiveness as well as the safety of Mosapride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients.
- Conditions
- Enteral Feeding Intolerance
- Being tested
- Mosapride Citrate Tablets, Metoclopramide 10mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mosapride Citrate TabletsDrug
Prokinetic Drug
Metoclopramide 10mgDrug
Prokinetic Drug
| Study group | Role | What they receive |
|---|---|---|
| Mosapride citrate group | Active comparator | These patients will receive Mosapride citrate (5 mg) three times daily for 7 days. Receives: Drug: Mosapride Citrate Tablets |
| Metoclopramide | Active comparator | These patients will receive metoclopramide (10 mg) three times daily for 7 days. Receives: Drug: Metoclopramide 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric residual volume will be measured by ultrasonography
the gastric residual volume will be assessed by ultrasonography on daily basis for the duration of the study period
Measured: GRV will be measured daily for the duration of therapy which is 7 days
Secondary outcomes (4)
Incidence of infectious complications such as pneumonia or any other infection complication will be assessed throughout the study period
Measured: Incidence of infectious complications will be assessed for the 7 days study period
Length of intensive care unit (ICU) stay will be assessed from the day of admission to ICU till the day of discharge from ICU
Measured: Length of ICU stay will be assessed from the day of admission to the ICU till the day of discharge from ICU
Any Adverse drug event as abdominal pain, QT prolongation and cardiac side effects that occur within the study period will be recorded throughout the study period
Measured: adverse drug events will be recorded for the study period of 7 days
Determining the adequacy of enteral nutrition will be assessed by measuring the enteral nutrition volume ratio at base line and at the end of the study period
the adequacy of enteral nutrition will be assessed by measuring the enteral nutrition volume ratio (the ratio of the actual received to the prescribed enteral nutrition volume ) at baseline of the study and at the end of the study.
Measured: Determining the adequacy of enteral nutrition will be assessed on daily base for the duration of study period of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enteral Feeding IntoleranceStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed El Mokadem, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826443
- Sponsor's protocol ID
- HM000185
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charoensareerat T, Bhurayanontachai R, Sitaruno S, Navasakulpong A, Boonpeng A, Lerkiatbundit S, Pattharachayakul S. Efficacy and Safety of Enteral Erythromycin Estolate in Combination With Intravenous Metoclopramide vs Intravenous Metoclopramide Monotherapy in Mechanically Ventilated Patients With Enteral Feeding Intolerance: A Randomized, Double-Blind, Controlled Pilot Study. JPEN J Parenter Enteral Nutr. 2021 Aug;45(6):1309-1318. doi: 10.1002/jpen.2013. Epub 2020 Oct 2.
PubMed 32895971Mohamed Elmokadem E, Khaled Abou El Fadl D, Bassiouny AM, Hanna Samy AE, Omar El Said N. Mosapride versus Metoclopramide in Critically Ill Patients with Enteral Feeding Intolerance: A Randomized, Double-Blinded Comparison. Drug Des Devel Ther. 2026 Mar 23;20:582745. doi: 10.2147/DDDT.S582745. eCollection 2026.
PubMed 41908938
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Mosapride Versus Metoclopramide for Enteral Feeding Intolerance in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06826443
- Acronym / sponsor ID
- HM000185
- Conditions
- Enteral Feeding Intolerance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 14 Feb 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.
Caring for critically ill patients in an intensive care unit (ICU) is considered a standard of care. According to the Society of Critical Care Medicine (SCCM), as a function of the complex nature of the care provided in the ICU, the ideal method to provide support to the critically ill involves the participation of a multi-professional staff.
Provision of nutrition support to the critically ill is now established as an essential part of patient care where aiming toward 100% of the predicted target may have resulted in reduced mortality and increased ventilator-free days in those who are premorbid malnourished. Despite these reported benefits, clinicians continue to deliver little more than half of the enteral nutrition (EN) they plan to provide, due to gastric motility disorders, patient intolerance and clinical interruptions. Also despite the availability of numerous clinical practice guidelines (CPGs) focused on feeding critically ill patients, observational studies have consistently demonstrated persistent and significant gaps between guideline recommendations and actual nutrition practice. Consequently, underfeeding is prevalent in the intensive care unit (ICU), with patients on average receiving only 60 % of the calories that are prescribed. Moreover, Among the barriers to adequate nutritional supply in the ICU which contributes to nutritional status deterioration, gastrointestinal disorders causing enteral feed intolerance are the most important and the most often mentioned in the literature. when gastric emptying was measured in critically ill patients, 46 % of them had evidence of delayed gastric emptying. Untreated slow gastric emptying has a plethora of clinical consequences such as vomiting, aspiration of gastric contents, pneumonia, and contributes significantly to the frequent interruptions and cessation of EN in the ICU, which results in inadequate nutritional delivery. Studies have shown an association between feeding intolerance, prolonged intensive care unit (ICU) stay, and increased risk of death.
Guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patients has demonstrated the importance of the use of prokinetic drugs to improve tolerance to gastric feeding in critically ill patients and achieve earlier discharge.
Prokinetic drugs act by promoting gastric motility, increase gastric emptying, prevent the retention and reflux of gastric contents and thus provide symptomatic relief.
Most of the prokinetic drugs are efficacious with prokinetic activity but the matter of major concern is their side effect profile. The most commonly used agent is metoclopramide. Although it is the most commonly used prokinetic to treat delayed gastric emptying and facilitate early enteral feeding, adverse complications limit its use including tachyphylaxis, tardive dyskinesia on long term use and QT prolongation predisposing to cardiac arrhythmias. Several drug targets have been identified to develop new promotility agents and several new medications are under investigation to overcome the side effects caused by most of the prokinetics .
Mosapride is another available prokinetic agent that enhances gastric motility through serotonin receptor agonism; resulting in prokinetic effects. It accelerates gastric emptying, improves gastric tension and sensitivity, and has anti-emetic action.
The aim of the current study is to compare the effectiveness as well as the safety of Mosapride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mosapride citrate group | Active comparator | Drug: Mosapride Citrate TabletsThese patients will receive Mosapride citrate (5 mg) three times daily for 7 days. |
| Metoclopramide | Active comparator | Drug: Metoclopramide 10mgThese patients will receive metoclopramide (10 mg) three times daily for 7 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aging between 18 and 60 years (of both sexes)
- Patients admitted to the ICU and are expected to stay in the ICU for not less than 7 days
- Patients prescribed enteral feeding.
Key exclusion criteria (8 listed)
- The following patients are
- Age less than 18 years or more than 60 years.
- Patients who had previous upper gastrointestinal tract surgery, obstruction, hemorrhage or history of GI disease.
- Patients who are clinically significant hepatic dysfunction. (>3 times above the upper end of normal range of bilirubin, γ-glutamyl transferase, aspartate transaminase, or lactate dehydrogenase)
- Patients who are on regular use of H2 blockers, prokinetic, proton pump inhibitor or anticholinergic agents for previous 4 weeks.
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 |
|---|---|---|
| Mosapride Citrate TabletsProkinetic Drug | Drug | Mosapride citrate group |
| Metoclopramide 10mgProkinetic Drug | Drug | Metoclopramide |
Primary outcome
Gastric residual volume will be measured by ultrasonography
Time frame: GRV will be measured daily for the duration of therapy which is 7 days
the gastric residual volume will be assessed by ultrasonography on daily basis for the duration of the study period
4 secondary outcomes
Incidence of infectious complications such as pneumonia or any other infection complication will be assessed throughout the study period
Time frame: Incidence of infectious complications will be assessed for the 7 days study period
Length of intensive care unit (ICU) stay will be assessed from the day of admission to ICU till the day of discharge from ICU
Time frame: Length of ICU stay will be assessed from the day of admission to the ICU till the day of discharge from ICU
Any Adverse drug event as abdominal pain, QT prolongation and cardiac side effects that occur within the study period will be recorded throughout the study period
Time frame: adverse drug events will be recorded for the study period of 7 days
Determining the adequacy of enteral nutrition will be assessed by measuring the enteral nutrition volume ratio at base line and at the end of the study period
Time frame: Determining the adequacy of enteral nutrition will be assessed on daily base for the duration of study period of 7 days
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 17 Feb 2025.
- Background: PubMed 32895971Charoensareerat T, Bhurayanontachai R, Sitaruno S, Navasakulpong A, Boonpeng A, Lerkiatbundit S, Pattharachayakul S. Efficacy and Safety of Enteral Erythromycin Estolate in Combination With Intravenous Metoclopramide vs Intravenous Metoclopramide Monotherapy in Mechanically Ventilated Patients With Enteral Feeding Intolerance: A Randomized, Double-Blind, Controlled Pilot Study. JPEN J Parenter Enteral Nutr. 2021 Aug;45(6):1309-1318. doi: 10.1002/jpen.2013. Epub 2020 Oct 2.
- Derived from this study: PubMed 41908938Mohamed Elmokadem E, Khaled Abou El Fadl D, Bassiouny AM, Hanna Samy AE, Omar El Said N. Mosapride versus Metoclopramide in Critically Ill Patients with Enteral Feeding Intolerance: A Randomized, Double-Blinded Comparison. Drug Des Devel Ther. 2026 Mar 23;20:582745. doi: 10.2147/DDDT.S582745. eCollection 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mosapride Citrate Tablets and Metoclopramide 10mg in people with Enteral Feeding Intolerance, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 8 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric residual volume will be measured by ultrasonography (time frame: GRV will be measured daily for the duration of therapy which is 7 days). 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 NCT06826443, which also lists 2 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 17 Feb 2025.