Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04838522 · ClinicalTrials.gov registry record
A Study of Prucalopride in Breastfeeding Women With Constipation
A clinical trial of Chronic Idiopathic Constipation (CIC), sponsored by Takeda.
- Recruiting
- Registry status
- 12
- Enrollment target
- 1
- Study location
NCT04838522: Recruiting study of Chronic Idiopathic Constipation (CIC), sponsored by Takeda.
NCT04838522 is a study of Chronic Idiopathic Constipation (CIC) that is actively recruiting participants, run by Takeda. The registered enrollment target is 12 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04838522, a study of Chronic Idiopathic Constipation (CIC), is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- 12 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER No Intervention
Study Locations (1)
California
- University of California San Diego - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-03-02 |
| Est. Completion | 2027-10-31 |
What NCT04838522 shows while recruiting
NCT04838522 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 1 condition, with Chronic Idiopathic Constipation (CIC) appearing as the primary indexed condition, and to 1 intervention - of which No Intervention is the first listed.
NCT04838522 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04838522 about?
NCT04838522 is a clinical study titled "A Study of Prucalopride in Breastfeeding Women With Constipation". 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. D...
What is the current status of trial NCT04838522?
This trial is currently recruiting. The enrollment target is 12 participants. The study started on 2022-03-02. Estimated completion is 2027-10-31.
What conditions does trial NCT04838522 study?
This clinical trial studies the following conditions: Chronic Idiopathic Constipation (CIC).
What interventions are being tested in trial NCT04838522?
The interventions under investigation include: No Intervention (OTHER).
Who is sponsoring clinical trial NCT04838522?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04838522 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Idiopathic Constipation (CIC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02602769 · 12 participants
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
- NCT02605421 · 12 participants · Phase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
- NCT02619448 · 12 participants · Early Phase 1
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
- NCT03311503 · 12 participants · Phase 1
Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI