Status:
COMPLETED
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
Lead Sponsor:
Forest Laboratories
Conditions:
Breast Feeding
Constipation
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Be a lactating female who has been actively breastfeeding or pumping for at least 4 weeks
- Be already taking linaclotide therapeutically for Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC)
- Weaning must not be underway
- Be willing to breastfeed or pump regularly during the study to maintain milk supply and discontinue breastfeeding for the 24-hour period of breast milk collection
Exclusion
- Clinically significant disease state in any body system, except for the indication being treated with linaclotide
- Any structural abnormality of the gastrointestinal (GI) tract, or a disease or condition that can affect GI motility
- Participation in any other clinical investigation using an experimental drug within 90 days
Key Trial Info
Start Date :
July 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02220348
Start Date
July 31 2014
End Date
May 31 2019
Last Update
December 19 2020
Active Locations (2)
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1
University of Iowa
Iowa City, Iowa, United States, 52242
2
Digestive Disease Specialists Inc (DDSI)
Oklahoma City, Oklahoma, United States, 73112