PregnancyPhase 4NCT05033041

Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide

A Phase 4 study testing Study drug metoclopramide in people with Pregnancy and Cesarean Section, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Our objective is to compare gastric volumes (mL) between women who receive metoclopramide versus placebo prior to scheduled cesarean delivery in appropriately fasted patients. If metoclopramide is found not to reduce gastric volumes this would inform future practice guidelines for obstetric anesthesia, which currently… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pregnancy, Cesarean Section, Aspiration
What is being tested?: Study drug metoclopramide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteUnited States
Study dates: 20 Oct 2021to 8 Feb 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Healthy (ASA Physical Status 2)
Age >18 years old
Non-obese (BMI <40 kg/m2)
Age >18 years
Term (>37 week)
Non-laboring parturient
Single gestation
Scheduled for a cesarean delivery and NPO

Who cannot join

Systemic disease such as diabetes mellitus (type 1 or 2)
Multiple gestation
Abnormality of upper GI tract
History of GI tract related surgical procedures
Use of gastric motility medications
Active labor

Show all 11Show fewer

Renal impairment (creatinine >2)
Non-English speaking
Cognitively impaired
History of QT prolongation
Use of general anesthesia

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern Memorial Hospital and Prentice Women's Hospital
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Comparison of Gastric Volumes by Gastric Ultrasound in Term Parturients Undergoing Scheduled Elective Cesarean Delivery With and Without Metoclopramide

We hypothesize that metoclopramide given to women with appropriate fasting prior to cesarean delivery does not result in any clinically significant reduction in gastric volume (mL) and therefore does not provide any additional benefit for aspiration prophylaxis but may expose patients to unnecessary side effects. A secondary objective will be to evaluate if gastric volume is a significant predictor of intraoperative nausea and vomiting.

Conditions: Pregnancy, Cesarean Section, Aspiration
Being tested: Study drug metoclopramide, Study drug placebo administration
Keywords: Pregnancy, Gastric Volume, Ultrasound Measurement, Aspiration Prevention, Cesarean Section

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study drug metoclopramideDrug
Intravenous administration of 10 mg metoclopramide
Study drug placebo administrationDrug
Intravenous administration of placebo (sterile normal saline)

Study groups in NCT05033041
Study group	Role	What they receive
Group 1 Study Drug Metoclopramide	Active comparator	Intravenous administration of 10 mg metoclopramide Receives: Drug: Study drug metoclopramide
Group 2 Study Drug Placebo	Placebo comparator	Intravenous administration of sterile normal saline Receives: Drug: Study drug placebo administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Gastric Volume (mL)
Change in gastric volume (mL) determined by gastric ultrasound before and 30 minutes after administration of study drug. Gastric volumes were calculated from the cross sectional area (CSA) area using both the Perlas (Volume=27.0+14.6*(RLD CSA (cm2)-1.28 * age)) and the Roukhomovsky method (volume=(0.18*RLD CSA (mm2))+(0.11*SUP CSA (mm2)-62.4) methods.
Measured: 30 minutes after administration of study drug

Secondary outcomes (14)

Subject Report of Nausea During Cesarean Section
Subject reported intraoperative nausea during the cesarean delivery
Measured: 24 hours
Adverse Events
Number of reported adverse events experienced for each group.
Measured: 72 hours
Intraoperative Nausea Occurrences
Number of nausea occurrences during cesarean section procedure
Measured: 24 hours
Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes
Total elapsed time in minutes from the placement of the intrathecal medications by anesthesiology team to the first experience of nausea reported by the participant.
Measured: 24 hours
Subject Experienced Vomiting During Cesarean Section
Subject experienced vomiting episode during the cesarean delivery procedure.
Measured: 24 Hours
Number of Intraoperative Vomiting Occurrences
Number of intraoperative vomiting occurrences during the cesarean section.
Measured: 24 Hours
Time From Intrathecal Anesthesia to Vomiting Episode in Minutes.
The elapsed time in minutes from anesthesia team placing the intrathecal medications to the first episode of vomiting during.
Measured: 24 Hours
Antiemetic Prophylaxis
Subject received antiemetic prophylaxis of ondansetron or dexamethasone prior to the cesarean section.
Measured: 24 Hours
PACU Antiemetic Treatment (n)
Number of participants who required antiemetic medications in the post anesthesia care unit
Measured: 24 hours
Nausea After PACU Discharge
Number of participants who experienced nausea after being discharged from the post anesthesia care unit
Measured: 72 hours
Elapsed Time From Study Drug to Second Ultrasound
Total elapsed time in minutes after study drug administered to second gastric ultrasound.
Measured: 24 hours
Second Ultrasound Cross Sectional Area (cm^2)
The cross sectional area in centimeters squared for the second gastric ultrasound which was performed 30 minutes after study medication administered
Measured: 24 hours
Post Treatment Estimated Volume (mL) Second Ultrasound
Gastric volume in milliliters of the second ultrasound obtained 30 minutes after study drug administration
Measured: 24 hours
Second Ultrasound Volume >1.5 * Weight (kg)
Number of subjects experiencing a volume greater than than 1.5 times weight in kilograms after the second gastric ultrasound 30 minutes after study medication administration.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 20218 Feb 2024

First posted2 Sep 2021
Study start20 Oct 2021
Primary completion30 Jan 2024
Study completion8 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for PregnancyStudies of the same condition, open and under way.
More trials run by Northwestern 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized controlled blinded study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05033041
Sponsor's protocol ID: STU00215570
Status last verified: Aug 2025
First submitted: 27 Aug 2021
Last updated: 11 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
PubMed 28045707
MENDELSON CL. The aspiration of stomach contents into the lungs during obstetric anesthesia. Am J Obstet Gynecol. 1946 Aug;52:191-205. doi: 10.1016/s0002-9378(16)39829-5. No abstract available.
PubMed 20993766
Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
PubMed 26580836
4. Knight M, Bunch K, Tuffnell D, Shakespeare J, Kotnis R, Kenyon S, Kurinczuk JJ (Eds.) on behalf of MBRRACE-UK. Saving Lives, Improving Mothers' Care - Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2016-18. Oxford: National Perinatal Epidemiology Unit, University of Oxford 2020.
Leus M, van de Ven A. IMAGES IN CLINICAL MEDICINE. An Acute Dystonic Reaction after Treatment with Metoclopramide. N Engl J Med. 2015 Oct;373(14):e16. doi: 10.1056/NEJMicm1412207. No abstract available.
PubMed 26422744
Mishriky BM, Habib AS. Metoclopramide for nausea and vomiting prophylaxis during and after Caesarean delivery: a systematic review and meta-analysis. Br J Anaesth. 2012 Mar;108(3):374-83. doi: 10.1093/bja/aer509. Epub 2012 Feb 3.
PubMed 22307240
Paranjothy S, Griffiths JD, Broughton HK, Gyte GM, Brown HC, Thomas J. Interventions at caesarean section for reducing the risk of aspiration pneumonitis. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004943. doi: 10.1002/14651858.CD004943.pub3.
PubMed 20091567
Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9.
PubMed 23302981
Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.
PubMed 24893784
Arzola C, Perlas A, Siddiqui NT, Carvalho JCA. Bedside Gastric Ultrasonography in Term Pregnant Women Before Elective Cesarean Delivery: A Prospective Cohort Study. Anesth Analg. 2015 Sep;121(3):752-758. doi: 10.1213/ANE.0000000000000818.
PubMed 26097988
Arzola C, Perlas A, Siddiqui NT, Downey K, Ye XY, Carvalho JCA. Gastric ultrasound in the third trimester of pregnancy: a randomised controlled trial to develop a predictive model of volume assessment. Anaesthesia. 2018 Mar;73(3):295-303. doi: 10.1111/anae.14131. Epub 2017 Dec 19.
PubMed 29265187
Lu SF, McCarthy RJ, Toledo P, Thomas CL, Gaston IN, Samworth AG, Ripchik PE, Troughton MB, Lopez CE, Kruse JH, Banayan JM. Effect of metoclopramide on gastric volume and nausea and vomiting in fasted patients undergoing elective cesarean delivery: a randomized clinical equivalence trial. Int J Obstet Anesth. 2025 Nov;64:104754. doi: 10.1016/j.ijoa.2025.104754. Epub 2025 Aug 14.
PubMed 40882347

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Gastric Volumes by Gastric Ultrasound in Term Parturients Undergoing Scheduled Elective Cesarean Delivery With and Without Metoclopramide
ClinicalTrials.gov ID: NCT05033041
Acronym / sponsor ID: STU00215570
Conditions: Pregnancy, Cesarean Section, Aspiration
Keywords: Pregnancy, Gastric Volume, Ultrasound Measurement, Aspiration Prevention, Cesarean Section
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: 20 Oct 2021 (actual)
Primary completion: 30 Jan 2024 (actual)
Study completion: 8 Feb 2024 (actual)
First posted: 2 Sep 2021 (actual)
Results: Posted 8 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized controlled blinded study

Arm	Type	Receives
Group 1 Study Drug Metoclopramide	Active comparator	Drug: Study drug metoclopramideIntravenous administration of 10 mg metoclopramide
Group 2 Study Drug Placebo	Placebo comparator	Drug: Study drug placebo administrationIntravenous administration of sterile normal saline

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Healthy (ASA Physical Status 2)
Age >18 years old
Non-obese (BMI <40 kg/m2)
Age >18 years
Term (>37 week)

Key exclusion criteria (11 listed)

Systemic disease such as diabetes mellitus (type 1 or 2)
Multiple gestation
Abnormality of upper GI tract
History of GI tract related surgical procedures
Use of gastric motility medications

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
Study drug metoclopramideIntravenous administration of 10 mg metoclopramide	Drug	Group 1 Study Drug Metoclopramide
Study drug placebo administrationIntravenous administration of placebo (sterile normal saline)	Drug	Group 2 Study Drug Placebo

Primary outcome

Change in Gastric Volume (mL)
Time frame: 30 minutes after administration of study drug
Change in gastric volume (mL) determined by gastric ultrasound before and 30 minutes after administration of study drug. Gastric volumes were calculated from the cross sectional area (CSA) area using both the Perlas (Volume=27.0+14.6*(RLD CSA (cm2)-1.28 * age)) and the Roukhomovsky method (volume=(0.18*RLD CSA (mm2))+(0.11*SUP CSA (mm2)-62.4) methods.

14 secondary outcomes

Subject Report of Nausea During Cesarean Section
Time frame: 24 hours
Adverse Events
Time frame: 72 hours
Intraoperative Nausea Occurrences
Time frame: 24 hours
Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes
Time frame: 24 hours
Subject Experienced Vomiting During Cesarean Section
Time frame: 24 Hours
Number of Intraoperative Vomiting Occurrences
Time frame: 24 Hours
Time From Intrathecal Anesthesia to Vomiting Episode in Minutes.
Time frame: 24 Hours
Antiemetic Prophylaxis
Time frame: 24 Hours
PACU Antiemetic Treatment (n)
Time frame: 24 hours
Nausea After PACU Discharge
Time frame: 72 hours
Elapsed Time From Study Drug to Second Ultrasound
Time frame: 24 hours
Second Ultrasound Cross Sectional Area (cm^2)
Time frame: 24 hours
Post Treatment Estimated Volume (mL) Second Ultrasound
Time frame: 24 hours
Second Ultrasound Volume >1.5 * Weight (kg)
Time frame: 24 hours

Results and safety

Results posted to the registry on 8 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 Study Drug Metoclopramide	38	38
Group 2 Study Drug Placebo	34	34

Primary outcome: Change in Gastric Volume (mL)

Time frame: 30 minutes after administration of study drug. Median (95% Confidence Interval). Unit: Milliliters

Measure	Group 1 Study Drug Metoclopramide n = 38	Group 2 Study Drug Placebo n = 33
Perlas method	-1 (-8 to 6)	-2 (-7 to 3)
Roukhomovsky formula	0 (-10 to 9)	1 (-6 to 6)

Group 1 Study Drug Metoclopramide vs Group 2 Study Drug Placebo: p = .001, t-test, 1 sided

Population analysed: One subject in the placebo group did not have a paired ultrasound (missing pre-treatment).

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 72 Hours. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 Study Drug Metoclopramide	0 of 38 (0%)	3 of 38 (7.9%)	0 of 38
Group 2 Study Drug Placebo	0 of 34 (0%)	6 of 34 (17.6%)	0 of 34

Limitations and caveats (from the sponsor): We recognize the potential limitations that some providers may still choose to administer metoclopramide to augment esophageal contractions despite its limited impact on esophageal junction compliance. While metoclopramide may help augment contractions, its use in fasted patients who are at low risk of gastric contents \>1.5mL/kg is unlikely to significantly impact aspiration risk, making its benefit in this context less clear.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28045707Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
Background: PubMed 20993766MENDELSON CL. The aspiration of stomach contents into the lungs during obstetric anesthesia. Am J Obstet Gynecol. 1946 Aug;52:191-205. doi: 10.1016/s0002-9378(16)39829-5. No abstract available.
Background: PubMed 26580836Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
Background4. Knight M, Bunch K, Tuffnell D, Shakespeare J, Kotnis R, Kenyon S, Kurinczuk JJ (Eds.) on behalf of MBRRACE-UK. Saving Lives, Improving Mothers' Care - Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2016-18. Oxford: National Perinatal Epidemiology Unit, University of Oxford 2020.
Background: PubMed 26422744Leus M, van de Ven A. IMAGES IN CLINICAL MEDICINE. An Acute Dystonic Reaction after Treatment with Metoclopramide. N Engl J Med. 2015 Oct;373(14):e16. doi: 10.1056/NEJMicm1412207. No abstract available.
Background: PubMed 22307240Mishriky BM, Habib AS. Metoclopramide for nausea and vomiting prophylaxis during and after Caesarean delivery: a systematic review and meta-analysis. Br J Anaesth. 2012 Mar;108(3):374-83. doi: 10.1093/bja/aer509. Epub 2012 Feb 3.
Background: PubMed 20091567Paranjothy S, Griffiths JD, Broughton HK, Gyte GM, Brown HC, Thomas J. Interventions at caesarean section for reducing the risk of aspiration pneumonitis. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004943. doi: 10.1002/14651858.CD004943.pub3.
Background: PubMed 23302981Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9.
Background: PubMed 24893784Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.
Background: PubMed 26097988Arzola C, Perlas A, Siddiqui NT, Carvalho JCA. Bedside Gastric Ultrasonography in Term Pregnant Women Before Elective Cesarean Delivery: A Prospective Cohort Study. Anesth Analg. 2015 Sep;121(3):752-758. doi: 10.1213/ANE.0000000000000818.
Background: PubMed 29265187Arzola C, Perlas A, Siddiqui NT, Downey K, Ye XY, Carvalho JCA. Gastric ultrasound in the third trimester of pregnancy: a randomised controlled trial to develop a predictive model of volume assessment. Anaesthesia. 2018 Mar;73(3):295-303. doi: 10.1111/anae.14131. Epub 2017 Dec 19.
Derived from this study: PubMed 40882347Lu SF, McCarthy RJ, Toledo P, Thomas CL, Gaston IN, Samworth AG, Ripchik PE, Troughton MB, Lopez CE, Kruse JH, Banayan JM. Effect of metoclopramide on gastric volume and nausea and vomiting in fasted patients undergoing elective cesarean delivery: a randomized clinical equivalence trial. Int J Obstet Anesth. 2025 Nov;64:104754. doi: 10.1016/j.ijoa.2025.104754. Epub 2025 Aug 14.
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. This study is not recruiting at the moment.

Jennifer Banayan, MD principal investigator

Northwestern University

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 Study drug metoclopramide in people with Pregnancy and Cesarean Section, run by Northwestern University at 1 site in United States.

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 8 inclusion and 11 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 11 Sep 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 United States. 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?

Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Gastric Volume (mL) (time frame: 30 minutes after administration of study drug). 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 NCT05033041, which also lists 12 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 11 Sep 2025.