Chronic Idiopathic Constipation (CIC)NCT04838522
A Study of Prucalopride in Breastfeeding Women With Constipation
An observational study of Chronic Idiopathic Constipation (CIC), run by Takeda at 1 site in United States.
Trial summary
Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk. Other aims are to check the growth and development of babies breastfed by their mothers who took prucalopride and to check if the babies had any side effects. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Idiopathic Constipation (CIC)
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2022to 31 Oct 2027
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female participants from United State (US) and Canada, who are currently being treated with prucalopride for functional constipation and breastfeeding a single infant between the ages of 10 days and 11 months 0 days. Infants will be followed for up to 12 months 30 days of age.
Who may be able to join
- Participants cannot be enrolled before all inclusion criteria are confirmed.
- Female participants with an ability to voluntarily provide verbal followed by written, signed, and dated (personally or via a legally authorized representative) informed consent as applicable to participate in the study.
- Participants greater than or equal to (>=) 18 years of age at the time of consent. This inclusion criterion will only be assessed at the time of enrollment.
- Participants who are currently breastfeeding a singleton infant who is between 10 days and 11 months 0 days, inclusive. Note that participants pumping breast milk and bottle feeding their infant breast milk are allowed to participate.
- Participants who are currently exclusively breastfeeding or breastfeeding with supplemental formula and/or solid food. Infants who are exclusively breastfed and do not yet eat solid food are preferred.
- Participants who are currently treated as prescribed by their physician with MOTEGRITY or RESOTRAN (generic forms of prucalopride not allowed) for functional constipation, including chronic idiopathic constipation (CIC) and irritable bowel syndrome-constipation (IBS-C), for at least 5 consecutive days at the time of taking the first breastmilk sample.
- Participants who agree to the conditions and requirements of the study including the sample collection, interview schedule, completion of developmental questionnaires, and release of medical records.
- Participants with an understanding, ability, and willingness to fully comply with study procedures and restrictions.
Who cannot join
- The participant will be excluded from the study if any of the following exclusion criteria are met:
- Participants who are breastfeeding an infant who: is hospitalized, has a major birth defect, or has a history of a disease that could affect absorption or drug disposition.
- Participants who have used MOTEGRITY or RESOTRAN while breastfeeding for a condition other than functional constipation.
- Participants who are pregnant at the time of enrollment.
- Participants who have started to wean their child from breast milk.
- Participants with a history of any hematological, hepatic, respiratory, cardiovascular, renal, gall bladder removal, or other current or recurrent disease that could affect the action, absorption, or disposition of prucalopride.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
La Jolla, California, 92093
Site Contact, 858-246-1704, chchambers@health.ucsd.edu
Christina Chambers, PhD, MPH
About this study
Official title: A Breast Milk Study in Lactating Women Who Have Been Prescribed Therapeutic Doses of MOTEGRITY® or RESOTRAN® (Prucalopride) for Chronic Idiopathic Constipation to Evaluate Prucalopride Concentrations in Breast Milk, and to Collect Incidental Safety Data From the Nursing Infants
Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk. Other aims are to check the growth and development of babies breastfed by their mothers who took prucalopride and to check if the babies had any side effects.
During the study, participants will provide one set of milk samples over 24 hours using an electric breast pump. Breast milk samples will be collected at home and will be shipped to the laboratory.
Also, participants will be asked questions during telephone interviews every 2 months in the first year of their baby's life. They will also be asked to complete growth and development questionnaires about their baby.
- Conditions
- Chronic Idiopathic Constipation (CIC)
- Being tested
- No Intervention
- Keywords
- Prucalopride, Motegrity, Pharmacokinetics, Lactation, Breastfeeding, Milk-only study, Infant growth and development, Infant neurodevelopment, Infant outcomes
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| All Study Participants | Participants with chronic idiopathic constipation who are treated with prucalopride oral tablets which was initiated prior to enrollment, and are breastfeeding their infant at the time of enrollment and sample collection will be observed prospectively. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose- Normalized Area Under the Milk Concentration-time Curve of Prucalopride (AUC [milk, norm])
AUC [milk, norm] will be derived from a series of 7 timed, full expression breast milk samples collected from a single breast using an electric breast pump over a 24-hour period of milk collection after a dose following at least 5 consecutive daily doses. AUC [milk, norm] will be normalized to 2-milligrams (mg) daily maternal dose.
Measured: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
Dose- Normalized Average Concentration of Prucalopride in Milk (C [ave, milk, norm])
C [ave, milk, norm] will be derived from a series of 7 timed, full expression breast milk samples collected from a single breast using an electric breast pump over a 24-hour period of milk collection after a dose following at least 5 consecutive daily doses. C [ave, milk, norm] will be normalized to 2-mg daily maternal dose.
Measured: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
Time Interval Over Which the AUC [milk, norm] Measured (T)
Time interval over which the AUC [milk, norm] is measured (T) will be reported.
Measured: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
Dose-normalized Daily Infant Dosage (DID [norm])
DID [norm] will be the estimated daily infant dose received by the infant through breastfeeding. DID [norm] will be normalized to 2-mg daily maternal dose.
Measured: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose
Percentage of Maternal Dose or Relative Infant Dose (RID [%])
RID [%]will be calculated as DID [norm] divided by (2 mg/day/maternal body weight (kg)) then multiplied by 100.
Measured: Up to 24 hours post-dose
Secondary outcomes (5)
Number of Infants With Adverse Events (AEs) Based on Maternal Report
Number of infants with AEs while being breastfed by a mother who is taking prucalopride will be obtained by maternal report (by phone).
Measured: Up to 1 year of age
Change in Length During the First Year of Life in Infant's
Growth changes in length in centimeters every 2 months during the first year of life in infant's breastfed by mothers taking prucalopride will be obtained by maternal report (by phone), and medical records abstraction.
Measured: At 6 and 12 months of age
Change in Weight During the First Year of Life in Infant's
Growth changes in weight in grams every 2 months during the first year of life in infant's breastfed by mothers taking prucalopride will be obtained by maternal report (by phone), and medical records abstraction.
Measured: At 6 and 12 months of age
Change in Head Circumference During the First Year of Infant's Life
Change in head circumference at 6 and 12 months will be reported.
Measured: At 6 and 12 months of age
Infant's Neurodevelopmental Performance Based on Ages and Stages Questionnaire-3 (ASQ-3)
Infant's neurodevelopmental progress at 12 months will be assessed by the ASQ-3 which will be completed by the mother. The ASQ-3 is a developmental screening instrument with 5 domains: (i) personal-social, (ii) gross motor, (iii) fine motor, (iv) problem solving, and (v) communication. All domains will be evaluated both continuously and categorically, with 3 categories: normal, borderline, abnormal. Abnormal scores of clinical concern are defined by test-based, standardized scoring criteria reported in the ASQ-3 User's Guide; these represent scores that are <2.0 SDs below the mean for each category. Borderline scores are scores that fall between 2.0 and 1.5 SDs below the mean. Each domain has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. ASQ-3 average = average score of 5 aspects.
Measured: Up to 1 year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start2 Mar 2022
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic Constipation (CIC)Studies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UC San Diego Human Milk Research Biorepository
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, TakedaStudy Director, Study director, UC San Diego Human Milk Research Biorepository
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838522
- Sponsor's protocol ID
- TAK-555-4006
- Other IDs
- EUPAS40105
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Breast Milk Study in Lactating Women Who Have Been Prescribed Therapeutic Doses of MOTEGRITY® or RESOTRAN® (Prucalopride) for Chronic Idiopathic Constipation to Evaluate Prucalopride Concentrations in Breast Milk, and to Collect Incidental Safety Data From the Nursing Infants
- ClinicalTrials.gov ID
- NCT04838522
- Acronym / sponsor ID
- TAK-555-4006
- Conditions
- Chronic Idiopathic Constipation (CIC)
- Keywords
- Prucalopride, Motegrity, Pharmacokinetics, Lactation, Breastfeeding, Milk-only study, Infant growth and development, Infant neurodevelopment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- UC San Diego Human Milk Research Biorepository
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 9 Apr 2021 (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.
Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk. Other aims are to check the growth and development of babies breastfed by their mothers who took prucalopride and to check if the babies had any side effects.
During the study, participants will provide one set of milk samples over 24 hours using an electric breast pump. Breast milk samples will be collected at home and will be shipped to the laboratory.
Also, participants will be asked questions during telephone interviews every 2 months in the first year of their baby's life. They will also be asked to complete growth and development questionnaires about their baby.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | – | Other: No InterventionParticipants with chronic idiopathic constipation who are treated with prucalopride oral tablets which was initiated prior to enrollment, and are breastfeeding their infant at the time of enrollment and sample collection will be observed prospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female participants from United State (US) and Canada, who are currently being treated with prucalopride for functional constipation and breastfeeding a single infant between the ages of 10 days and 11 months 0 days. Infants will be followed for up to 12 months 30 days of age.
Key inclusion criteria (8 listed)
- Participants cannot be enrolled before all inclusion criteria are confirmed.
- Female participants with an ability to voluntarily provide verbal followed by written, signed, and dated (personally or via a legally authorized representative) informed consent as applicable to participate in the study.
- Participants greater than or equal to (>=) 18 years of age at the time of consent. This inclusion criterion will only be assessed at the time of enrollment.
- Participants who are currently breastfeeding a singleton infant who is between 10 days and 11 months 0 days, inclusive. Note that participants pumping breast milk and bottle feeding their infant breast milk are allowed to participate.
- Participants who are currently exclusively breastfeeding or breastfeeding with supplemental formula and/or solid food. Infants who are exclusively breastfed and do not yet eat solid food are preferred.
Key exclusion criteria (6 listed)
- The participant will be excluded from the study if any of the following exclusion criteria are met:
- Participants who are breastfeeding an infant who: is hospitalized, has a major birth defect, or has a history of a disease that could affect absorption or drug disposition.
- Participants who have used MOTEGRITY or RESOTRAN while breastfeeding for a condition other than functional constipation.
- Participants who are pregnant at the time of enrollment.
- Participants who have started to wean their child from breast milk.
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 |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | All Study Participants |
Primary outcome
Dose- Normalized Area Under the Milk Concentration-time Curve of Prucalopride (AUC [milk, norm])
Time frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
AUC [milk, norm] will be derived from a series of 7 timed, full expression breast milk samples collected from a single breast using an electric breast pump over a 24-hour period of milk collection after a dose following at least 5 consecutive daily doses. AUC [milk, norm] will be normalized to 2-milligrams (mg) daily maternal dose.
Dose- Normalized Average Concentration of Prucalopride in Milk (C [ave, milk, norm])
Time frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
C [ave, milk, norm] will be derived from a series of 7 timed, full expression breast milk samples collected from a single breast using an electric breast pump over a 24-hour period of milk collection after a dose following at least 5 consecutive daily doses. C [ave, milk, norm] will be normalized to 2-mg daily maternal dose.
Time Interval Over Which the AUC [milk, norm] Measured (T)
Time frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
Time interval over which the AUC [milk, norm] is measured (T) will be reported.
Dose-normalized Daily Infant Dosage (DID [norm])
Time frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose
DID [norm] will be the estimated daily infant dose received by the infant through breastfeeding. DID [norm] will be normalized to 2-mg daily maternal dose.
Percentage of Maternal Dose or Relative Infant Dose (RID [%])
Time frame: Up to 24 hours post-dose
RID [%]will be calculated as DID [norm] divided by (2 mg/day/maternal body weight (kg)) then multiplied by 100.
5 secondary outcomes
Number of Infants With Adverse Events (AEs) Based on Maternal Report
Time frame: Up to 1 year of age
Change in Length During the First Year of Life in Infant's
Time frame: At 6 and 12 months of age
Change in Weight During the First Year of Life in Infant's
Time frame: At 6 and 12 months of age
Change in Head Circumference During the First Year of Infant's Life
Time frame: At 6 and 12 months of age
Infant's Neurodevelopmental Performance Based on Ages and Stages Questionnaire-3 (ASQ-3)
Time frame: Up to 1 year of age
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 1 May 2026.
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.
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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.
Study Director study director
Takeda
Study Director study director
UC San Diego Human Milk Research Biorepository
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Idiopathic Constipation (CIC), run by Takeda 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 6 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
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 Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose- Normalized Area Under the Milk Concentration-time Curve of Prucalopride (AUC [milk, norm]) (time frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.