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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Time Interval Over Which the AUC [milk, norm] Measured (T)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: No Intervention (Other)
结局指标
主要结局
Time Interval Over Which the AUC [milk, norm] Measured (T)
时间窗: 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])
时间窗: 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 [%])
时间窗: 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.
Dose- Normalized Area Under the Milk Concentration-time Curve of Prucalopride (AUC [milk, norm])
时间窗: 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])
时间窗: 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.
次要结局
- Number of Infants With Adverse Events (AEs) Based on Maternal Report(Up to 1 year of age)
- Change in Length During the First Year of Life in Infant's(At 6 and 12 months of age)
- Change in Weight During the First Year of Life in Infant's(At 6 and 12 months of age)
- Change in Head Circumference During the First Year of Infant's Life(At 6 and 12 months of age)
- Infant's Neurodevelopmental Performance Based on Ages and Stages Questionnaire-3 (ASQ-3)(Up to 1 year of age)