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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: Completed Phase 1 study, sponsored by Forest Laboratories.
NCT02220348 is a Phase 1 study that has completed, run by Forest Laboratories. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02220348 record still lists
NCT02220348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which linaclotide is the first listed.
NCT02220348 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02220348's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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