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

Temple University Hospital

3401 N Broad St
Philadelphia, Pennsylvania

(215) 707-2000