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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS40105 | Other Identifier | EUPAS Register Number |
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| Name | Class |
|---|---|
| UC San Diego Human Milk Research Biorepository | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is a non-interventional study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Up to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 1 year of age |
| Change in Length During the First Year of Life in Infant's |
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Inclusion Criteria:
Participants cannot be enrolled before all inclusion criteria are confirmed.
Exclusion Criteria:
The participant will be excluded from the study if any of the following exclusion criteria are met:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Study Director | UC San Diego Human Milk Research Biorepository | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | La Jolla | California | 92093 | United States |
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| Label | URL |
|---|---|
| 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. | View source |
| 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. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Breast Milk At the Dawn of New Discoveries | View IPD |
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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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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Breast milk
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. |
| 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. | 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. | 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. | Up to 1 year of age |