Lactating Women on Select DOINCT03511118
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
An observational study of Lactating Women on Select DOI and Breastfed Infants of Mothers on Select DOI, run by Duke University at 22 sites in 2 countries.
Trial summary
Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI
- What is being tested?
- Tranexamic acid (TXA), labetalol and metformin
- How many people
- 1,600 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 4 Oct 2018to 31 Jul 2028
- Phase
- Observational
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Lactating women receiving DOIs per SOC, as prescribed by their healthcare providers, and their breastfed infants.
Who may be able to join
- Lactating women who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.
- Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines.
Who cannot join
- Any concomitant condition which, in the opinion of the physicians providing patient care or the principal investigator conducting the study, would preclude a subject's participation in the study.
- Known pregnancy during PK sampling.
Trial locations and contacts
22 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 2 countries
United States20 sites, 13 recruiting
- Completed
University of New Mexico, Health Sciences Center
Albuquerque, New Mexico, 87131
- Recruiting
Texas Tech University Health Sciences Center School of Medicine.
Amarillo, Texas, 79106
Katie Boatler, katie.boatler@ttuhsc.edu
Kaytlin Krutsch, PharnD
- Completed
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
- Completed
Northwestern University
Chicago, Illinois, 60611
- Recruiting
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60614
Laura Fearn, 312-227-6280, lfearn@luriechildrens.org
Mayra Gomez, 312-227-8274, mmgomez@luriechildrens.org
- Recruiting
Duke University Maternal and Fetal Medicine
Durham, North Carolina, 27705
Thelma Fitzgerald, 919-684-1224, thelma.fitzgerald@duke.edu
Jordynn Akins, 919-681-0013, jordynn.akins@duke.edu
- Recruiting
University of Texas Medical Branch - Galveston
Galveston, Texas, 77555
Sashank Komanduri, sakomand@utmb.edu
Lizzet Aguillon, 409-772-0305, liaguill@utmb.edu
- Recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Felicia Ortiz, 1-713-500-6467, felecia.ortiz@uth.tmc.edu
Pamela Berens, MD
- Recruiting
The Women's Hospital of Texas
Houston, Texas, 77054
Olaide Balogun, olaide.ashimibalogun@pediatrix.comare.com
Olaide Balogun, MD
- Completed
Indiana University Health
Indianapolis, Indiana, 46202
- Active, not recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
- Recruiting
University of California-San Diego Medical Center
La Jolla, California, 92093
Kerri Bertrand, 858-246-1713, kdutcher@ucsd.edu
Gretchen Bandoli, 858-246-1733, gbandoli@ucsd.edu
- Recruiting
Loma Linda University Health
Loma Linda, California, 92354
Jose Navarro, 909-558-5830, jdnavarro@llu.edu
Stephanie Wells, 909-558-5830, scwells@llu.edu
- Recruiting
Children's Hospital and Clinics - Minneapolis
Minneapolis, Minnesota, 55404
Quast Emily, 612-813-6864, emily.quast@childrensmn.org
Molly fisher, 612-813-6864, molly.fisher@childrensmn.org
- Completed
Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine
Philadelphia, Pennsylvania, 19104
- Recruiting
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
Leigh Ann Shaver, shaverla2@upmc.edu
Anne-Marie Rick, MD
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Monica Rincon, 503-494-8748, rincon@ohsu.edu
Daniela Cramer, 503-494-8742, cramerda@ohsu.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
Kelly Christensen, 801-674-7234, kelly.vorwaller@hsc.utah.edu
Kathleen Job
- Recruiting
University of Texas Health Science Center
San Antonio, Texas, 78229
Janette Rodela, RN, (615) 344-9551, Janette.Rodela@HCAhealthcare.com
Olaide Balogun, MD
- Completed
University of Washington
Seattle, Washington, 98195-7630
Canada2 sites
- Completed
Lawson Health Research Institute
London, Ontario, N6A 5W9
- Completed
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T IC5
About this study
Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants.
Read the detailed description
The purpose of this study is to understand if the study drugs of interest are found in breastmilk and how much; to estimate the amount of drug that is consumed by breastfed infants and what effect this may have on infants; and to share what we learn with other researchers. The study drugs of interest have Food and Drug Administration (FDA) approval, but there is little or no information about the amount of drug found in the breastmilk of mothers who take them; the amount of drug that may be transferred to their infant's through breastmilk; or the effects this transfer may have on their infants. During this study we will ask to collect breastmilk and blood from mothers, and blood from infants, to measure the amount of study drug of interest in these body fluids. Results from this study will help researchers better understand how much of the study drug of interest is in your blood and breastmilk, and how much of the study drug of interest may be in your infant's blood because of breastfeeding.
- Being tested
- Tranexamic acid (TXA), labetalol, metformin, nifedipine, clindamycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid (TXA)Drug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
labetalolDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
metforminDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
nifedipineDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
clindamycinDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
oxycodoneDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
azithromycinDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
escitalopramDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
sertralineDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
ondansetronDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
CiprofloxacinDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DoxycyclineDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
LevofloxacinDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
MethylphenidateDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
SumatriptanDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
CitalopramDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
CyclobenzaprineDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
FurosemideDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
GabapentinDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
HydrochlorothiazideDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
HydroxyureaDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
RosuvastatinDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
TopiramateDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
TrazodoneDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
ValganciclovirDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
VenlafaxineDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
VerapamilDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
RemdesivirDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
AnakinraDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
TocilizumabDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
FluvoxamineDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
AmoxicillinDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
BupropionDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DuloxetineDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
HydrocodoneDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
LevetiracetamDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
ParoxetineDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
BuprenorphineDrug
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid (TXA) | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Tranexamic acid (TXA) | |
| labetalol | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: labetalol | |
| metformin | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: metformin | |
| nifedipine | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: nifedipine | |
| clindamycin | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: clindamycin | |
| oxycodone | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: oxycodone | |
| azithromycin | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: azithromycin | |
| escitalopram | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: escitalopram | |
| sertraline | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: sertraline | |
| ondansetron | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: ondansetron | |
| Ciprofloxacin | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Ciprofloxacin | |
| Doxycycline | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Doxycycline | |
| Levofloxacin | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Levofloxacin | |
| Methylphenidate | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Methylphenidate | |
| Sumatriptan | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Sumatriptan | |
| Citalopram | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Citalopram | |
| Cyclobenzaprine | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Cyclobenzaprine | |
| Furosemide | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Furosemide | |
| Gabapentin | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Gabapentin | |
| Hydrochlorothiazide | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Hydrochlorothiazide | |
| Hydroxyurea | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Hydroxyurea | |
| Rosuvastatin | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Rosuvastatin | |
| Topiramate | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Topiramate | |
| Trazodone | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Trazodone | |
| Valganciclovir | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Valganciclovir | |
| Venlafaxine | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Venlafaxine | |
| Verapamil | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Verapamil | |
| Remdesivir | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Remdesivir | |
| Anakinra | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Anakinra | |
| Tocilizumab | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Tocilizumab | |
| Fluvoxamine | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Fluvoxamine | |
| Amoxicillin | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Amoxicillin | |
| Bupropion | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Bupropion | |
| Buprenorphine | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Buprenorphine | |
| Hydrocodone | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Hydrocodone | |
| Levetiracetam | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Levetiracetam | |
| Paroxetine | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Paroxetine | |
| Duloxetine | No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.
The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose. Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
M/P ratio
Characterize the pharmacokinetics using maternal milk/plasma exposure ratio is calculated by dividing the BMS01 drug of interest breastmilk concentration by the BMS01 drug of interest in maternal plasma concentration.
Measured: Until the infant becomes 180 days of age
DID
Pharmacokinetics is characterized by estimated daily infant dose-daily infant dose which estimates the quantity of drug delivered to an infant via breastmilk in a given day.
Measured: Until the infant becomes 180 days of age
RID
Pharmacokinetics is characterized by relative infant dose is a method of relating the potential dose of the drug delivered to the infant to the typical therapeutic dose given to the mother.
Measured: Until the infant becomes 180 days of age
I/M ratio
Pharmacokinetics is characterized using infant maternal/exposure ratio. IM ratio is calculated using the average infant plasma concentration of the BMS01 drug of interest and historical value of clearance in infants.
Measured: Until the infant becomes 180 days of age
Secondary outcomes (4)
Safety profile of commonly used drugs in infants exposed to drugs in breastmilk
see Cohort 1-31 for listing of drugs
Measured: Until the infant becomes 180 days of age
AE
Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Adverse Events(AE) which are collected at each time point when the study-specific procedure occurred and up until 1 hour after.
Measured: Up until 180 days of age
SAE
Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Serious Adverse Events which are directly related to study procedures and were recorded from participants (infant or mother) at each time point when the study-specific procedure occurred and up until 1 hour after.
Measured: Up until 180 days of age
ESI
Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Events of Special Interest(ESI) which include any pre-specified safety event that could be related to BMS01 drug of interest exposure. ESI's are only assessed for infants and only at study visits from the time the BMS01 DOI was initiated in mother and infant began breast milk feeding through the end of the study / infant age ≤ 180 days
Measured: Until the infant becomes 180 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start4 Oct 2018
- Primary completion23 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lactating Women on Select DOIStudies of the same condition, open and under way.
- More trials run by Duke 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Emmes Company, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Kanecia Obie Zimmerman, Duke University
- Investigators
- Samia Aleem, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511118
- Sponsor's protocol ID
- Pro00088919
- Other IDs
- HHSN275201000003I/27500051
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2018
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Job KM, Dallmann A, Parry S, Saade G, Haas DM, Hughes B, Berens P, Chen JY, Fu C, Humphrey K, Hornik C, Balevic S, Zimmerman K, Watt K. Development of a Generic Physiologically-Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk. Clin Pharmacol Ther. 2022 May;111(5):1111-1120. doi: 10.1002/cpt.2530. Epub 2022 Mar 5.
PubMed 35076931