A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically



Status:Recruiting
Conditions:Constipation, Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 45
Updated:3/24/2019
Start Date:July 31, 2014
End Date:May 31, 2019
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@allergan.com
Phone:877‐277‐8566

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An Open-label, Multiple-dose, Milk-only Lactation Study in Lactating Women 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 (145 μg
or 290 μg) in lactating women receiving the drug therapeutically.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
3
sites
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Philadelphia, PA
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