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NCT04869280 · ClinicalTrials.gov registry record
Post-Marketing Study of Prucalopride Safety In Pregnancy
A clinical trial of Chronic Idiopathic Constipation (CIC), sponsored by Takeda.
- Active
- Registry status
- 127
- Enrollment target
- 1
- Study location
NCT04869280: Active study of Chronic Idiopathic Constipation (CIC), sponsored by Takeda.
NCT04869280 is a study of Chronic Idiopathic Constipation (CIC) that is active but no longer recruiting, run by Takeda. The registered enrollment target is 127 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04869280, a study of Chronic Idiopathic Constipation (CIC), is active but no longer recruiting, sponsored by Takeda.
- ACTIVE NOT RECRUITING
- Registry status
- 127 participants
- Enrollment target
- 1
- Study location
Study Summary
This study collects information on pregnant women with ongoing constipation who took prucalopride and those who did not take prucalopride. The main aim of the study is to learn if any medical problems in pregnant women or their infants might be related to taking prucalopride during pregnancy. Participants are not required to take prucalopride during the study. The study is non-interventional. Women and their infants are followed during pregnancy and for 1 year after pregnancy to collect information on maternal, pregnancy, and infant outcomes. During the study, participants will be asked questions during 3 telephone interviews; 2 during pregnancy and 1 just after their expected delivery date. Participants who took or are taking prucalopride will be asked more detailed questions about this during these interviews. All information is collected remotely, and no visits to the study site are required. Also, all participants will be asked to complete a questionnaire about their baby when their baby is about 1 year old.
Primary Outcome
Major structural defects are defined and classified using the US Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects. All major structural defects will be adjudicated by the co-investigator on this study.
Conditions Studied
Interventions
- OTHER No Intervention
Study Locations (1)
California
- University of California San Diego - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2021-05-21 |
| Est. Completion | 2027-02-01 |
What the registry record for NCT04869280 still lists
NCT04869280 is an observational study that tracks outcomes without assigning an intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap.
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.
NCT04869280 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04869280 about?
NCT04869280 is a clinical study titled "Post-Marketing Study of Prucalopride Safety In Pregnancy". This study collects information on pregnant women with ongoing constipation who took prucalopride and those who did not take prucalopride. The main aim of the study is to learn if any medical problems in pregnant women or their infants might be related to taking prucalopride during pregnancy. Parti...
What is the current status of trial NCT04869280?
This trial is currently active not recruiting. The enrollment target is 127 participants. The study started on 2021-05-21. Estimated completion is 2027-02-01.
What conditions does trial NCT04869280 study?
This clinical trial studies the following conditions: Chronic Idiopathic Constipation (CIC).
What interventions are being tested in trial NCT04869280?
The interventions under investigation include: No Intervention (OTHER).
Who is sponsoring clinical trial NCT04869280?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04869280 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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