Neonatal Abstinence SyndromePhase 4NCT02851303
Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
A Phase 4 study testing Morphine and Methadone in people with Neonatal Abstinence Syndrome, run by University of New Mexico at 1 site in United States.
Trial summary
This study investigates the use of methadone versus morphine wean for the treatment of neonatal abstinence syndrome for infants exposed to opioids in utero. Half of infants who require pharmacotherapy for NAS will receive a methadone wean, and half will receive a morphine wean. Read more about this study
- Who is it for?
- Ages 0 to 12 hours
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- Morphine and Methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 30 Sep 2018
- 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 0 to 12 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born at University of New Mexico Hospital
- Greater than 34 weeks gestation
- Primary in-utero drug exposure was opioids other than buprenorphine
- Maternal or infant urine drug screen positive for methadone and/or opioids on admission
Who cannot join
- Born prior to 34 weeks
- Neonatal intensive care unit admission
- Serious medical comorbidities
- Primary substance exposure in-utero was buprenorphine, or was not opioids
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87106
About this study
This study investigates the use of methadone versus morphine wean for the treatment of neonatal abstinence syndrome for infants exposed to opioids in utero. Half of infants who require pharmacotherapy for NAS will receive a methadone wean, and half will receive a morphine wean. Length of hospital stay, length of treatment and parent satisfaction will be studied.
Read the detailed description
Neonates exposed to opiates in utero can develop a constellation of withdrawal symptoms known as neonatal abstinence syndrome (NAS). Infants with NAS are at risk for multiple medical complications including failure to thrive and seizures, they often require prolonged hospital stays and account for significant health care costs. At University of New Mexico, infants exposed to methadone or heroin in utero who develop NAS requiring pharmacologic treatment undergo a treatment wean with methadone, whereas infants exposed to buprenorphine undergo a wean with morphine. However, morphine is used frequently to treat neonatal abstinence syndrome among methadone-exposed infants throughout the US, and optimal pharmacologic treatment for NAS remains unknown. Anecdotal evidence at the investigators institution suggests that infants treated with morphine have shorter hospital stays compared to infants treated with methadone. Investigators propose a pilot randomized controlled trial to evaluate morphine vs methadone treatment of infants with in-utero methadone or heroin exposure. Specifically, length of treatment, need for additional medication to treat withdrawal, and length of hospital stay will be compared.
When women are admitted to Labor and Delivery and/or up to 12 hours postpartum, research staff will approach patients about study enrollment. Participants will be approached for study enrollment if medication list on admission includes methadone, if participants self-report methadone use prenatally, and/ or if urine drug screen is positive for methadone or opiates on admission. If women choose to enroll in the study, and their infants require treatment for NAS, their infants will be randomized and assigned a study number for treatment using the methadone or morphine protocols at the time treatment is required.
All infants will be monitored for signs of withdrawal using the standard UNM NAS scoring protocol. Standard of care at UNM is to treat infants exposed to opioids in-utero with methadone if they require pharmacologic therapy for NAS, therefore treatment will not be withheld if they choose not to enroll in the study. Standard of care is also to obtain a urine drug screen on all infants with reported exposure to opiates in pregnancy. Enrolled patients will thus undergo routine urine drug screening. The only difference from standard care with regards to the study protocol is the treatment of half of the methadone or heroin exposed infants with morphine. The morphine protocol is proven for safety and efficacy currently in buprenorphine exposed infants. Once randomized, infants will continue on the protocol until discharge. At discharge, parents will complete a patient satisfaction survey.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- Morphine, Methadone
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Morphine wean protocol as described in arm description
MethadoneDrug
Methadone wean protocol as described in arm description
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Active comparator | Dose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml)
Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose
Morphine Maintenance/Escalation
* Maintain dose if score 0-8
* Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16
* Increase score by 0.06 if score 17-20
Weaning Instructions:
* Maintain on dose 48 hrs before starting weaning
* Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12
Re-escalation
* If neonate scores 9-12 re-score as described for initiation,
* If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs
* If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc Receives: Drug: Morphine |
| Methadone | Active comparator | Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
Number of days in hospital after birth
Measured: assessed at hospital discharge, approximately 7-30 days
Secondary outcomes (6)
Length of Treatment
Measured: assessed at hospital discharge, approximately 7-30 days
Need for Additional Agent to Treat Withdrawal, Determined by Chart Review of Medication Administration Record of Administered Medications for Withdrawal Treatment (Example: Clonidine or Phenobarbital)
clonidine
Measured: assessed at hospital discharge, approximately 7-30 days
Need for Feeding Assistance, Determined by Chart Review of Discharge Summary, Specifically Evaluating for Need for Nasogastric Tube Placement or Peripheral Parenteral Nutrition.
Measured: assessed at hospital discharge, approximately 7-30 days
Need for NICU Transfer, as Determined by Chart Review of Discharge Summary.
Measured: assessed at hospital discharge, approximately 7-30 days
Breastfeeding Initiation and Continuation at Hospital Discharge
Assessed through chart review of discharge summary documentation of method of infant feeding at time of discharge
Measured: assessed at hospital discharge, approximately 7-30 days
Total Morphine Equivalent Dose Received
Measured: assessed at hospital discharge, approximately 7-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2018
- Study completion30 Sep 2018
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 (9)Papers the sponsor has linked to this study.
- Other trials for Neonatal Abstinence SyndromeStudies 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
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Beth Sutter, University of New Mexico
- Investigators
- Mary Beth Sutter, MD, Principal investigator, Attending Physician, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851303
- Sponsor's protocol ID
- 16-176
- Status last verified
- May 2023
- First submitted
- 19 Jul 2016
- Last updated
- 24 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hudak ML, Tan RC; COMMITTEE ON DRUGS; COMMITTEE ON FETUS AND NEWBORN; American Academy of Pediatrics. Neonatal drug withdrawal. Pediatrics. 2012 Feb;129(2):e540-60. doi: 10.1542/peds.2011-3212. Epub 2012 Jan 30.
PubMed 22291123Patrick SW, Davis MM, Lehmann CU, Cooper WO. Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012. J Perinatol. 2015 Aug;35(8):650-5. doi: 10.1038/jp.2015.36. Epub 2015 Apr 30.
PubMed 25927272Hall ES, Wexelblatt SL, Crowley M, Grow JL, Jasin LR, Klebanoff MA, McClead RE, Meinzen-Derr J, Mohan VK, Stein H, Walsh MC; OCHNAS Consortium. A multicenter cohort study of treatments and hospital outcomes in neonatal abstinence syndrome. Pediatrics. 2014 Aug;134(2):e527-34. doi: 10.1542/peds.2013-4036.
PubMed 25070317Winter M, Nelson DS, Milton GW. Leucocyte adherence inhibition test for the detection of cell-mediated immunity to malignant melanoma. Aust N Z J Med. 1980 Aug;10(4):405-9. doi: 10.1111/j.1445-5994.1980.tb04090.x.
PubMed 7000060Logan BA, Brown MS, Hayes MJ. Neonatal abstinence syndrome: treatment and pediatric outcomes. Clin Obstet Gynecol. 2013 Mar;56(1):186-92. doi: 10.1097/GRF.0b013e31827feea4.
PubMed 23314720Hall ES, Wexelblatt SL, Crowley M, Grow JL, Jasin LR, Klebanoff MA, McClead RE, Meinzen-Derr J, Mohan VK, Stein H, Walsh MC; OCHNAS Consortium. Implementation of a Neonatal Abstinence Syndrome Weaning Protocol: A Multicenter Cohort Study. Pediatrics. 2015 Oct;136(4):e803-10. doi: 10.1542/peds.2015-1141. Epub 2015 Sep 14.
PubMed 26371196Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010 Dec 9;363(24):2320-31. doi: 10.1056/NEJMoa1005359.
PubMed 21142534Sutter MB, Watson H, Yonke N, Weitzen S, Leeman L. Morphine versus methadone for neonatal opioid withdrawal syndrome: a randomized controlled pilot study. BMC Pediatr. 2022 Jun 15;22(1):345. doi: 10.1186/s12887-022-03401-3.
PubMed 35705944Zankl A, Martin J, Davey JG, Osborn DA. Opioid treatment for opioid withdrawal in newborn infants. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD002059. doi: 10.1002/14651858.CD002059.pub4.
PubMed 34231914
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
- ClinicalTrials.gov ID
- NCT02851303
- Acronym / sponsor ID
- 16-176
- Conditions
- Neonatal Abstinence Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Posted 24 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the use of methadone versus morphine wean for the treatment of neonatal abstinence syndrome for infants exposed to opioids in utero. Half of infants who require pharmacotherapy for NAS will receive a methadone wean, and half will receive a morphine wean. Length of hospital stay, length of treatment and parent satisfaction will be studied.
Detailed description
Neonates exposed to opiates in utero can develop a constellation of withdrawal symptoms known as neonatal abstinence syndrome (NAS). Infants with NAS are at risk for multiple medical complications including failure to thrive and seizures, they often require prolonged hospital stays and account for significant health care costs. At University of New Mexico, infants exposed to methadone or heroin in utero who develop NAS requiring pharmacologic treatment undergo a treatment wean with methadone, whereas infants exposed to buprenorphine undergo a wean with morphine. However, morphine is used frequently to treat neonatal abstinence syndrome among methadone-exposed infants throughout the US, and optimal pharmacologic treatment for NAS remains unknown. Anecdotal evidence at the investigators institution suggests that infants treated with morphine have shorter hospital stays compared to infants treated with methadone. Investigators propose a pilot randomized controlled trial to evaluate morphine vs methadone treatment of infants with in-utero methadone or heroin exposure. Specifically, length of treatment, need for additional medication to treat withdrawal, and length of hospital stay will be compared.
When women are admitted to Labor and Delivery and/or up to 12 hours postpartum, research staff will approach patients about study enrollment. Participants will be approached for study enrollment if medication list on admission includes methadone, if participants self-report methadone use prenatally, and/ or if urine drug screen is positive for methadone or opiates on admission. If women choose to enroll in the study, and their infants require treatment for NAS, their infants will be randomized and assigned a study number for treatment using the methadone or morphine protocols at the time treatment is required.
All infants will be monitored for signs of withdrawal using the standard UNM NAS scoring protocol. Standard of care at UNM is to treat infants exposed to opioids in-utero with methadone if they require pharmacologic therapy for NAS, therefore treatment will not be withheld if they choose not to enroll in the study. Standard of care is also to obtain a urine drug screen on all infants with reported exposure to opiates in pregnancy. Enrolled patients will thus undergo routine urine drug screening. The only difference from standard care with regards to the study protocol is the treatment of half of the methadone or heroin exposed infants with morphine. The morphine protocol is proven for safety and efficacy currently in buprenorphine exposed infants. Once randomized, infants will continue on the protocol until discharge. At discharge, parents will complete a patient satisfaction survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Active comparator | Drug: MorphineDose given q 3 - 4 hrs with feeds; do not exceed 4 hrs between doses Morphine (0.04mg/0.1ml) Score Dose For Initiation 0-8 0 None 9-12 0.04 mg/dose 13-16 0.08 mg/dose 17-20 0.12 mg/dose 21-24 0.16 mg/dose 25 or above 0.20mg/dose Morphine Maintenance/Escalation * Maintain dose if score 0-8 * Increase dose by 0.02 if score is 9-12 (rescore before dosing) • Increase dose by 0.04 if score 13-16 * Increase score by 0.06 if score 17-20 Weaning Instructions: * Maintain on dose 48 hrs before starting weaning * Wean 0.02 mg morphine every day for a score is 0-8 • Defer wean for score 9-12 Re-escalation * If neonate scores 9-12 re-score as described for initiation, * If second score is in 9-12 increase morphine 0.01 mg q3-4 hrs • If 2 consecutive scores 13-16, increase 0.02 mg q3-4 hrs * If 2 consecutive scores in 17-20, increase 0.04 mg q3-4 hrs etc |
| Methadone | Active comparator | Drug: MethadoneStep 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours |
Who may qualify
- Ages
- 0 to 12 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Born at University of New Mexico Hospital
- Greater than 34 weeks gestation
- Primary in-utero drug exposure was opioids other than buprenorphine
- Maternal or infant urine drug screen positive for methadone and/or opioids on admission
Key exclusion criteria (4 listed)
- Born prior to 34 weeks
- Neonatal intensive care unit admission
- Serious medical comorbidities
- Primary substance exposure in-utero was buprenorphine, or was not opioids
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 |
|---|---|---|
| MorphineMorphine wean protocol as described in arm description | Drug | Morphine |
| MethadoneMethadone wean protocol as described in arm description | Drug | Methadone |
Primary outcome
Length of Hospital Stay
Time frame: assessed at hospital discharge, approximately 7-30 days
Number of days in hospital after birth
6 secondary outcomes
Length of Treatment
Time frame: assessed at hospital discharge, approximately 7-30 days
Need for Additional Agent to Treat Withdrawal, Determined by Chart Review of Medication Administration Record of Administered Medications for Withdrawal Treatment (Example: Clonidine or Phenobarbital)
Time frame: assessed at hospital discharge, approximately 7-30 days
Need for Feeding Assistance, Determined by Chart Review of Discharge Summary, Specifically Evaluating for Need for Nasogastric Tube Placement or Peripheral Parenteral Nutrition.
Time frame: assessed at hospital discharge, approximately 7-30 days
Need for NICU Transfer, as Determined by Chart Review of Discharge Summary.
Time frame: assessed at hospital discharge, approximately 7-30 days
Breastfeeding Initiation and Continuation at Hospital Discharge
Time frame: assessed at hospital discharge, approximately 7-30 days
Total Morphine Equivalent Dose Received
Time frame: assessed at hospital discharge, approximately 7-30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22291123Hudak ML, Tan RC; COMMITTEE ON DRUGS; COMMITTEE ON FETUS AND NEWBORN; American Academy of Pediatrics. Neonatal drug withdrawal. Pediatrics. 2012 Feb;129(2):e540-60. doi: 10.1542/peds.2011-3212. Epub 2012 Jan 30.
- Background: PubMed 25927272Patrick SW, Davis MM, Lehmann CU, Cooper WO. Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012. J Perinatol. 2015 Aug;35(8):650-5. doi: 10.1038/jp.2015.36. Epub 2015 Apr 30.
- Background: PubMed 25070317Hall ES, Wexelblatt SL, Crowley M, Grow JL, Jasin LR, Klebanoff MA, McClead RE, Meinzen-Derr J, Mohan VK, Stein H, Walsh MC; OCHNAS Consortium. A multicenter cohort study of treatments and hospital outcomes in neonatal abstinence syndrome. Pediatrics. 2014 Aug;134(2):e527-34. doi: 10.1542/peds.2013-4036.
- Background: PubMed 7000060Winter M, Nelson DS, Milton GW. Leucocyte adherence inhibition test for the detection of cell-mediated immunity to malignant melanoma. Aust N Z J Med. 1980 Aug;10(4):405-9. doi: 10.1111/j.1445-5994.1980.tb04090.x.
- Background: PubMed 23314720Logan BA, Brown MS, Hayes MJ. Neonatal abstinence syndrome: treatment and pediatric outcomes. Clin Obstet Gynecol. 2013 Mar;56(1):186-92. doi: 10.1097/GRF.0b013e31827feea4.
- Background: PubMed 26371196Hall ES, Wexelblatt SL, Crowley M, Grow JL, Jasin LR, Klebanoff MA, McClead RE, Meinzen-Derr J, Mohan VK, Stein H, Walsh MC; OCHNAS Consortium. Implementation of a Neonatal Abstinence Syndrome Weaning Protocol: A Multicenter Cohort Study. Pediatrics. 2015 Oct;136(4):e803-10. doi: 10.1542/peds.2015-1141. Epub 2015 Sep 14.
- Background: PubMed 21142534Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010 Dec 9;363(24):2320-31. doi: 10.1056/NEJMoa1005359.
- Derived from this study: PubMed 35705944Sutter MB, Watson H, Yonke N, Weitzen S, Leeman L. Morphine versus methadone for neonatal opioid withdrawal syndrome: a randomized controlled pilot study. BMC Pediatr. 2022 Jun 15;22(1):345. doi: 10.1186/s12887-022-03401-3.
- Derived from this study: PubMed 34231914Zankl A, Martin J, Davey JG, Osborn DA. Opioid treatment for opioid withdrawal in newborn infants. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD002059. doi: 10.1002/14651858.CD002059.pub4.
- 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.
Mary Beth Sutter, MD principal investigator
Attending Physician, Assistant Professor
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 Morphine and Methadone in people with Neonatal Abstinence Syndrome, run by University of New Mexico 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 4 inclusion and 4 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 24 May 2023. 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. 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 24 May 2023). 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?
Length of Hospital Stay (time frame: assessed at hospital discharge, approximately 7-30 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 NCT02851303, which also lists 9 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 24 May 2023.