A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®

Completed

Conditions studied: Chronic Idiopathic Constipation

In brief

This is a multi-center, open-label study evaluating pharmacokinetics of TRULANCE® (plecanatide) in breast milk of lactating women treated with TRULANCE

Key facts

Study ID

NCT03551873

Run by

Bausch Health Americas, Inc.

People needed

7

Starts

2018-06-21

Expected to finish

2018-12-14

Last updated by the study team

2019-11-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Females ≥ 18 years of age
• Has been breastfeeding or actively pumping for at least 4 weeks
• Has been prescribed TRULANCE by a healthcare provider and has taken it for a minimum of 14 consecutive days before anticipated Baseline Visit
• Has the ability to understand and communicate the requirements of the study and is willing to continue breastfeeding or regular pumping in order to maintain milk supply for the duration of the study
• Weaning must not be underway

You may not qualify if…

• Has clinically significant medical or psychiatric condition (as determined by the Medical Monitor) other than the medical condition being treated with TRULANCE
• Has mastitis or other condition that would prevent the collection of milk from one or both breasts.
• Has participated in an investigational drug study within the 90 days prior to CRU admission

Where it is running

• Synergy Research Center 002 — North Hollywood, California, United States
• Syergy Research Center 003 — Tamarac, Florida, United States
• Synergy Research Center 001 — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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