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NCT02220348 · ClinicalTrials.gov registry record · Phase 1
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
A Phase 1 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT02220348 is a Phase 1 study that has completed, run by Forest Laboratories. The registered enrollment target is 7 participants.
The verdict
NCT02220348, a Phase 1 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg, 145 μg, or 290 μg) in lactating women receiving the drug therapeutically.
Interventions
- DRUG linaclotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2014-07-31 |
| Est. Completion | 2019-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02220348
The ClinicalTrials.gov registry entry for NCT02220348 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which linaclotide is the first listed.
NCT02220348 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02220348 about?
NCT02220348 is a clinical study titled "A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically". The purpose of this study is to determine the amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg, 145 μg, or 290 μg) in lactating women receiving the drug therapeutically.
What is the current status of trial NCT02220348?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2014-07-31. Estimated completion is 2019-05-31.
What interventions are being tested in trial NCT02220348?
The interventions under investigation include: linaclotide (DRUG).
Who is sponsoring clinical trial NCT02220348?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
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