Semaglutide-Induced Gastric MotilityPhase 4NCT07254715
Effect of Itopride on Semaglutide Gastroparesis
A Phase 4 study testing Itopride HCI 50 mg in people with Semaglutide-Induced Gastric Motility and Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Semaglutide delays gastric emptying and increases the risk of aspiration with anesthesia; So, the addition of prokinetics as Itopride, could enhance gastric emptying and hasten surgery. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Semaglutide-Induced Gastric Motility, Anesthesia
- What is being tested?
- Itopride HCI 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 30 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists grade I- III.
- Age: 40-60 years.
- BMI: 20-30 kg/m2.
- Diabetic patients on semaglutide (0.5-1mg) SC weekly.
- Undergoing elective hysterectomy.
Who cannot join
- Declining to give written informed consent.
- history of upper abdominal surgery or the presence of hiatal hernia.
- Other medications inducing gastroparesis (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, and lithium).
- History of allergy to Itopride.
- History of cardiac arrhythmia or abnormal ECG.
- Neurologic diseases (including Parkinson's disease and multiple sclerosis)
- Hepatic or renal failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Itopride Improve Semaglutide Induced Gastroparesis Ultrasound Before Anesthesia? Randomized Controlled Trial
Semaglutide delays gastric emptying and increases the risk of aspiration with anesthesia; So, the addition of prokinetics as Itopride, could enhance gastric emptying and hasten surgery.
The investigator will evaluate the effect of Itopride on Semaglutide-induced gastroparesis and residual gastric contents after 8 hours of fasting by gastric ultrasound before anesthesia.
Read the detailed description
Semaglutide delays gastric emptying and increases the risk of aspiration with anesthesia; So, the addition of prokinetics as Itopride could enhance gastric emptying and hastens surgery.
Semaglutide, a glucagon-like peptide-1 (GLP-1) agonist, is gaining popularity for the treatment of type 2 diabetes mellitus (T2DM) and obesity; Semaglutide stimulates insulin excretion and delays gastric emptying.Itopride, a novel prokinetic agent, acts as a dopamine D2 receptor antagonist and an acetylcholine esterase inhibitor. Itopride shows promise in managing gastroparesis symptoms by accelerating gastric emptying, improving gastric tension and sensitivity, and exerting antiemetic effects.
The investigator designed this prospective, randomized, double-blind controlled study to evaluate the effect of Itopride on Semaglutide induced gastroparesis and residual gastric contents after 8-hours fasting by gastric ultrasound before anesthesia.
- Conditions
- Semaglutide-Induced Gastric Motility, Anesthesia
- Being tested
- Itopride HCI 50 mg, Placebo
- Keywords
- itopride, gastric ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itopride HCI 50 mgDrug
Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days
PlaceboDrug
Daily placebo tablet TID, 1 hour before meals for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Itopride HCL | Active comparator | Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days Receives: Drug: Itopride HCI 50 mg |
| Placebo | Placebo comparator | Daily placebo tablet TID, 1 hour before meals for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual gastric contents
Residual gastric contents (clear fluid ˃1.5 mL/kg or the presence of solids) by ultrasound in the right lateral decubitus after 8-hours fasting .
Measured: on day 7
Secondary outcomes (2)
Residual gastric contents on day 3 and day 5.
Measured: on day 3 and day 5
Incidence of vomiting during anesthesia
Measured: during anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Jan 2026
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Semaglutide-Induced Gastric MotilityStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Samir Abdelsalam, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254715
- Sponsor's protocol ID
- FMASU R263/2025
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Itopride Improve Semaglutide Induced Gastroparesis Ultrasound Before Anesthesia? Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07254715
- Acronym / sponsor ID
- FMASU R263/2025
- Conditions
- Semaglutide-Induced Gastric Motility, Anesthesia
- Keywords
- itopride, gastric ultrasound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 28 Nov 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.
Semaglutide delays gastric emptying and increases the risk of aspiration with anesthesia; So, the addition of prokinetics as Itopride, could enhance gastric emptying and hasten surgery.
The investigator will evaluate the effect of Itopride on Semaglutide-induced gastroparesis and residual gastric contents after 8 hours of fasting by gastric ultrasound before anesthesia.
Detailed description
Semaglutide delays gastric emptying and increases the risk of aspiration with anesthesia; So, the addition of prokinetics as Itopride could enhance gastric emptying and hastens surgery.
Semaglutide, a glucagon-like peptide-1 (GLP-1) agonist, is gaining popularity for the treatment of type 2 diabetes mellitus (T2DM) and obesity; Semaglutide stimulates insulin excretion and delays gastric emptying.Itopride, a novel prokinetic agent, acts as a dopamine D2 receptor antagonist and an acetylcholine esterase inhibitor. Itopride shows promise in managing gastroparesis symptoms by accelerating gastric emptying, improving gastric tension and sensitivity, and exerting antiemetic effects.
The investigator designed this prospective, randomized, double-blind controlled study to evaluate the effect of Itopride on Semaglutide induced gastroparesis and residual gastric contents after 8-hours fasting by gastric ultrasound before anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itopride HCL | Active comparator | Drug: Itopride HCI 50 mgDaily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboDaily placebo tablet TID, 1 hour before meals for 7 days |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- American Society of Anesthesiologists grade I- III.
- Age: 40-60 years.
- BMI: 20-30 kg/m2.
- Diabetic patients on semaglutide (0.5-1mg) SC weekly.
- Undergoing elective hysterectomy.
Key exclusion criteria (7 listed)
- Declining to give written informed consent.
- history of upper abdominal surgery or the presence of hiatal hernia.
- Other medications inducing gastroparesis (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, and lithium).
- History of allergy to Itopride.
- History of cardiac arrhythmia or abnormal ECG.
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 |
|---|---|---|
| Itopride HCI 50 mgDaily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days | Drug | Itopride HCL |
| PlaceboDaily placebo tablet TID, 1 hour before meals for 7 days | Drug | Placebo |
Primary outcome
Residual gastric contents
Time frame: on day 7
Residual gastric contents (clear fluid ˃1.5 mL/kg or the presence of solids) by ultrasound in the right lateral decubitus after 8-hours fasting .
2 secondary outcomes
Residual gastric contents on day 3 and day 5.
Time frame: on day 3 and day 5
Incidence of vomiting during anesthesia
Time frame: during anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Itopride HCI 50 mg in people with Semaglutide-Induced Gastric Motility and Anesthesia, 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 25 Sep 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual gastric contents (time frame: on day 7). 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 25 Sep 2026.