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

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

sites

University of Iowa

101 Jessup Hall
Iowa City, Iowa 52242

(319) 335-3500