Postoperative Nausea and VomitingPhase 2NCT06488001
Preoperative Use of Pantoprazole for Prevention of Post Operative Nausea and Vomiting in Gynecologic Surgery
A Phase 2 study testing pantoprazole in people with Postoperative Nausea and Vomiting, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
Trial summary
The goal of this clinical trial is to see if pantoprazole (a proton pump inhibitor used for acid reflux/heart burn) can reduce nausea and vomiting after gynecologic surgery in women between the ages of 18 and 79. Researchers will compare a placebo to the active medication. Read more about this study
- Who is it for?
- Ages 18 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- pantoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2022to Dec 2026
- Phase
- Phase 2
- 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 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing elective gynecological surgery by either an open abdominal or minimally invasive approach (to include both endoscopic and vaginal). Procedure must be performed under general anesthesia.
Who cannot join
- Pregnant,
- Patients with gastrointestinal disease requiring ongoing medical management.
- Prior gastrointestinal surgery with the exception of diagnostic procedures, appendectomy and cholecystectomy.
- Patients with a history of H2 receptor blocker use, proton pump inhibitor use or other GERD specific therapy within 30 days of surgery.
- Any patient identified by their surgical care team as having a history of PONV warranting additional perioperative prophylaxis.
- Known r suspected malignancy
- Lactose intolerance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melissa Infosino, MD contact
United States1 site, 1 recruiting
- Recruiting
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
Casey Timmerman, DO, 757-953-7767, casey.j.timmerman2.mil@health.mil
Casey Timmerman, DO
About this study
The goal of this clinical trial is to see if pantoprazole (a proton pump inhibitor used for acid reflux/heart burn) can reduce nausea and vomiting after gynecologic surgery in women between the ages of 18 and 79.
Researchers will compare a placebo to the active medication.
Participants will be asked to take three pills around their surgery, two taken before and one taken the night after.
Read the detailed description
Randomization Recruited subjects will be randomly assigned a study number and be provided a numerically matching medication packet prepared in advance by pharmacy support staff. Identical opaque gelatin capsules will be prepared in advance containing either placebo or 40 mg of Pantoprazole, each medication packet will have three capsules of either active drug or placebo. The patient and all study members will be blinded. Participants will be instructed when to take their specific medication (PPI or placebo) prior to surgery along with their other ERAS protocol instructions.
Study Medication/Placebo Administration Subjects will take either oral Pantoprazole 40 mg or placebo the evening prior to surgery, 2 hours prior to scheduled surgery (time to peak bioavailability is 2.5 hrs in adults) and 12 hours following surgery completion. The final dose is to provide additional effect given that PONV can continue up to 24 hours following surgery. All surgeries at this facility utilize an ERAS protocol includes the perioperative use of Zofran 4 mg and Decadron 4 mg for all patients; this practice will continue unchanged for participating patients.
Data Collection/Post-Operative Patient Satisfaction Evaluation Subjects will be evaluated postoperatively with a visual analog scale (VAS) to determine incidence and severity of PONV; this has been used similarly in prior studies. A score of 0 indicates no nausea and higher scores reflect progressively greater severity. Assessment with VAS will be conducted two hours after and the morning following surgery completion; scores will be compared between groups. The VAS will be administered in person by study personnel while patients remain in hospital. Study personnel will administer the VAS by phone for patients who have been discharged by the morning following surgery. Time to first meal (PO) will also be measured and compared as will the use of rescue antiemetics to treat nausea postoperatively. Patients will also have a postoperative telehealth visit one week following their operation to review patient satisfaction and rate their experience using the Treatment Acceptability and Preference (TRAP) Questionnaire. This is a validated standard questionnaire that will be verbally administered by study personnel and used to assess patient satisfaction with their perioperative treatment specific to PONV [14]. All data will be collected and stored on password protected excel spreadsheets or in a locked secure environment in the Women's Health Clinic. Subject ID log will be kept separate from data collection tool to maintain blinding by a study team member. Essentris records will be reviewed by the study team member to specifically evaluate time to first meal, reported vomiting and any rescue antiemetic use. All data collected to include VAS and TRAP scores will be collected and stored on password protected excel spreadsheets. Subject ID log will be kept separate from data collection tool to maintain blinding. Analysis will be conducted on appropriate statistical software. To confirm accurate data entry from Essentris, 10% of patient records will be randomly reviewed by a second study investigator (other than the original study team member) and compared prior to data analysis. If any discrepancies are identified in this process, Essentris data will then be reviewed again for all study participants. A list of all discrepancies will be maintained and adjudicated by a third investigator to verify accuracy.
Incidental Malignancy If an unexpected malignancy is found during the surgical procedure, the subject will be withdrawn from the study and all data collected prior to surgery will be discarded.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- pantoprazole, Placebo
- Keywords
- PONV, Postoperative nausea
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pantoprazoleDrug
Also called proton pump inhibitor
Pantoprazole 40mg given the night before surgery, 2 hours prior to surgery, and the evening after surgery.
PlaceboDrug
Placebo given the night before surgery, 2 hours prior to surgery, and the evening after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | This arm receives the placebo drug. This medication is taken the night before, 2 hours before surgery, and the night after surgery. Receives: Drug: Placebo |
| Active | Active comparator | This arm receives the pantoprazole 40mg tablet. This medication is taken the night before, 2 hours before surgery, and the night after surgery. Receives: Drug: pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Nausea and Vomiting
Postoperative nausea and vomiting compared between two groups using Visual Analog Scale from 0-10. A score of 0 indicates no nausea and higher scores reflect progressively greater severity.
Measured: From enrollment until their postoperative visit at 6 weeks
Secondary outcomes (1)
Time to Oral Intake
Measure the time from surgery until patients can tolerate oral intake.
Measured: From surgery until first meal, usually within a few hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start26 Aug 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, Portsmouth
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Casey Timmerman, DO, Principal investigator, United States Naval Medical Center, Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488001
- Sponsor's protocol ID
- NMCP.2021.0131
- Status last verified
- May 2025
- First submitted
- 28 Jun 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fortier J, Chung F, Su J. Unanticipated admission after ambulatory surgery--a prospective study. Can J Anaesth. 1998 Jul;45(7):612-9. doi: 10.1007/BF03012088.
PubMed 9717590Sidani S, Epstein DR, Bootzin RR, Moritz P, Miranda J. Assessment of preferences for treatment: validation of a measure. Res Nurs Health. 2009 Aug;32(4):419-31. doi: 10.1002/nur.20329.
PubMed 19434647Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.
PubMed 10757584Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002 Sep;46(8):921-8. doi: 10.1034/j.1399-6576.2002.460801.x.
PubMed 12190791Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976 Nov;21(11):953-6. doi: 10.1007/BF01071906.
PubMed 984016Kwon YS, Choi JW, Lee HS, Kim JH, Kim Y, Lee JJ. Effect of a Preoperative Proton Pump Inhibitor and Gastroesophageal Reflux Disease on Postoperative Nausea and Vomiting. J Clin Med. 2020 Mar 18;9(3):825. doi: 10.3390/jcm9030825.
PubMed 32197451Koivuranta M, Laara E, Snare L, Alahuhta S. A survey of postoperative nausea and vomiting. Anaesthesia. 1997 May;52(5):443-9. doi: 10.1111/j.1365-2044.1997.117-az0113.x.
PubMed 9165963Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3.
PubMed 23035051Apfel CC, Turan A, Souza K, Pergolizzi J, Hornuss C. Intravenous acetaminophen reduces postoperative nausea and vomiting: a systematic review and meta-analysis. Pain. 2013 May;154(5):677-689. doi: 10.1016/j.pain.2012.12.025. Epub 2013 Jan 11.
PubMed 23433945Apfel CC, Kranke P, Eberhart LH, Roos A, Roewer N. Comparison of predictive models for postoperative nausea and vomiting. Br J Anaesth. 2002 Feb;88(2):234-40. doi: 10.1093/bja/88.2.234.
PubMed 11883387Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.
PubMed 32467512Carlisle JB, Stevenson CA. Drugs for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD004125. doi: 10.1002/14651858.CD004125.pub2.
PubMed 16856030Kalogera E, Dowdy SC. Enhanced Recovery Pathway in Gynecologic Surgery: Improving Outcomes Through Evidence-Based Medicine. Obstet Gynecol Clin North Am. 2016 Sep;43(3):551-73. doi: 10.1016/j.ogc.2016.04.006.
PubMed 27521884Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022.
PubMed 10475299
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Use of Pantoprazole for Prevention of Post Operative Nausea and Vomiting in Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT06488001
- Acronym / sponsor ID
- NMCP.2021.0131
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- PONV, Postoperative nausea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, PortsmouthUS federal agency
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Jul 2024 (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 clinical trial is to see if pantoprazole (a proton pump inhibitor used for acid reflux/heart burn) can reduce nausea and vomiting after gynecologic surgery in women between the ages of 18 and 79.
Researchers will compare a placebo to the active medication.
Participants will be asked to take three pills around their surgery, two taken before and one taken the night after.
Detailed description
Randomization Recruited subjects will be randomly assigned a study number and be provided a numerically matching medication packet prepared in advance by pharmacy support staff. Identical opaque gelatin capsules will be prepared in advance containing either placebo or 40 mg of Pantoprazole, each medication packet will have three capsules of either active drug or placebo. The patient and all study members will be blinded. Participants will be instructed when to take their specific medication (PPI or placebo) prior to surgery along with their other ERAS protocol instructions.
Study Medication/Placebo Administration Subjects will take either oral Pantoprazole 40 mg or placebo the evening prior to surgery, 2 hours prior to scheduled surgery (time to peak bioavailability is 2.5 hrs in adults) and 12 hours following surgery completion. The final dose is to provide additional effect given that PONV can continue up to 24 hours following surgery. All surgeries at this facility utilize an ERAS protocol includes the perioperative use of Zofran 4 mg and Decadron 4 mg for all patients; this practice will continue unchanged for participating patients.
Data Collection/Post-Operative Patient Satisfaction Evaluation Subjects will be evaluated postoperatively with a visual analog scale (VAS) to determine incidence and severity of PONV; this has been used similarly in prior studies. A score of 0 indicates no nausea and higher scores reflect progressively greater severity. Assessment with VAS will be conducted two hours after and the morning following surgery completion; scores will be compared between groups. The VAS will be administered in person by study personnel while patients remain in hospital. Study personnel will administer the VAS by phone for patients who have been discharged by the morning following surgery. Time to first meal (PO) will also be measured and compared as will the use of rescue antiemetics to treat nausea postoperatively. Patients will also have a postoperative telehealth visit one week following their operation to review patient satisfaction and rate their experience using the Treatment Acceptability and Preference (TRAP) Questionnaire. This is a validated standard questionnaire that will be verbally administered by study personnel and used to assess patient satisfaction with their perioperative treatment specific to PONV [14]. All data will be collected and stored on password protected excel spreadsheets or in a locked secure environment in the Women's Health Clinic. Subject ID log will be kept separate from data collection tool to maintain blinding by a study team member. Essentris records will be reviewed by the study team member to specifically evaluate time to first meal, reported vomiting and any rescue antiemetic use. All data collected to include VAS and TRAP scores will be collected and stored on password protected excel spreadsheets. Subject ID log will be kept separate from data collection tool to maintain blinding. Analysis will be conducted on appropriate statistical software. To confirm accurate data entry from Essentris, 10% of patient records will be randomly reviewed by a second study investigator (other than the original study team member) and compared prior to data analysis. If any discrepancies are identified in this process, Essentris data will then be reviewed again for all study participants. A list of all discrepancies will be maintained and adjudicated by a third investigator to verify accuracy.
Incidental Malignancy If an unexpected malignancy is found during the surgical procedure, the subject will be withdrawn from the study and all data collected prior to surgery will be discarded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThis arm receives the placebo drug. This medication is taken the night before, 2 hours before surgery, and the night after surgery. |
| Active | Active comparator | Drug: pantoprazoleThis arm receives the pantoprazole 40mg tablet. This medication is taken the night before, 2 hours before surgery, and the night after surgery. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing elective gynecological surgery by either an open abdominal or minimally invasive approach (to include both endoscopic and vaginal). Procedure must be performed under general anesthesia.
Key exclusion criteria (7 listed)
- Pregnant,
- Patients with gastrointestinal disease requiring ongoing medical management.
- Prior gastrointestinal surgery with the exception of diagnostic procedures, appendectomy and cholecystectomy.
- Patients with a history of H2 receptor blocker use, proton pump inhibitor use or other GERD specific therapy within 30 days of surgery.
- Any patient identified by their surgical care team as having a history of PONV warranting additional perioperative prophylaxis.
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 |
|---|---|---|
| pantoprazoleAlso: proton pump inhibitorPantoprazole 40mg given the night before surgery, 2 hours prior to surgery, and the evening after surgery. | Drug | Active |
| PlaceboPlacebo given the night before surgery, 2 hours prior to surgery, and the evening after surgery. | Drug | Placebo |
Primary outcome
Postoperative Nausea and Vomiting
Time frame: From enrollment until their postoperative visit at 6 weeks
Postoperative nausea and vomiting compared between two groups using Visual Analog Scale from 0-10. A score of 0 indicates no nausea and higher scores reflect progressively greater severity.
1 secondary outcome
Time to Oral Intake
Time frame: From surgery until first meal, usually within a few hours.
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 21 May 2025.
- Background: PubMed 9717590Fortier J, Chung F, Su J. Unanticipated admission after ambulatory surgery--a prospective study. Can J Anaesth. 1998 Jul;45(7):612-9. doi: 10.1007/BF03012088.
- Background: PubMed 19434647Sidani S, Epstein DR, Bootzin RR, Moritz P, Miranda J. Assessment of preferences for treatment: validation of a measure. Res Nurs Health. 2009 Aug;32(4):419-31. doi: 10.1002/nur.20329.
- Background: PubMed 10757584Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x.
- Background: PubMed 12190791Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002 Sep;46(8):921-8. doi: 10.1034/j.1399-6576.2002.460801.x.
- Background: PubMed 984016Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976 Nov;21(11):953-6. doi: 10.1007/BF01071906.
- Background: PubMed 32197451Kwon YS, Choi JW, Lee HS, Kim JH, Kim Y, Lee JJ. Effect of a Preoperative Proton Pump Inhibitor and Gastroesophageal Reflux Disease on Postoperative Nausea and Vomiting. J Clin Med. 2020 Mar 18;9(3):825. doi: 10.3390/jcm9030825.
- Background: PubMed 9165963Koivuranta M, Laara E, Snare L, Alahuhta S. A survey of postoperative nausea and vomiting. Anaesthesia. 1997 May;52(5):443-9. doi: 10.1111/j.1365-2044.1997.117-az0113.x.
- Background: PubMed 23035051Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3.
- Background: PubMed 23433945Apfel CC, Turan A, Souza K, Pergolizzi J, Hornuss C. Intravenous acetaminophen reduces postoperative nausea and vomiting: a systematic review and meta-analysis. Pain. 2013 May;154(5):677-689. doi: 10.1016/j.pain.2012.12.025. Epub 2013 Jan 11.
- Background: PubMed 11883387Apfel CC, Kranke P, Eberhart LH, Roos A, Roewer N. Comparison of predictive models for postoperative nausea and vomiting. Br J Anaesth. 2002 Feb;88(2):234-40. doi: 10.1093/bja/88.2.234.
- Background: PubMed 32467512Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.
- Background: PubMed 16856030Carlisle JB, Stevenson CA. Drugs for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD004125. doi: 10.1002/14651858.CD004125.pub2.
- 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.
Melissa Infosino, MD contact
Casey Timmerman, DO principal investigator
United States Naval Medical Center, Portsmouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pantoprazole in people with Postoperative Nausea and Vomiting, run by United States Naval Medical Center, Portsmouth 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 1 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: looking for participants now, as of the sponsor's last update on 21 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Casey Timmerman, DO (757-953-7767, casey.j.timmerman2.mil@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Nausea and Vomiting (time frame: From enrollment until their postoperative visit at 6 weeks). 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 NCT06488001, which also lists 14 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 21 May 2025.