DRUG
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
Status
Completed
Phase
Phase 1
Enrollment
7
Locations
2
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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 μg) in lactating women receiving the drug therapeutically.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 19, 2014
Study start
Jul 31, 2014
Primary completion
May 31, 2019
Study completion
May 31, 2019
Results posted
Not reported
Registry updated
Dec 19, 2020
Outcomes
What the study measures.
Primary outcomes
Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk
Time frame · From Baseline (Day 1) to Day 4
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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
Study locations
2 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Iowa
Iowa City, Iowa, United States
Digestive Disease Specialists Inc (DDSI)
Oklahoma City, Oklahoma, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Linaclotide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Study of Virtual Reality and Linaclotide for IBS-C
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Not applicable
Recruiting
65
2026-07
Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Colorectal Adenoma · Stage 0 Colorectal Cancer AJCC v8
Phase 2
Active, not recruiting
150
2026-07
A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
AbbVie · Functional Constipation (FC) · Chronic Idiopathic Constipation (CIC)
Phase 3
Completed
123
2026-05
Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis
University of Nottingham · Cystic Fibrosis (CF)
Early Phase 1
Recruiting
26
2026-05
GCC Agonist Signal in the Small Intestine
University of Wisconsin, Madison · Barrett Esophagus · Gastroesophageal Reflux Disease
Phase 1
Completed
43
2026-04
Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation
Texas Tech University Health Sciences Center, El Paso · Chronic Constipation · Diabete Mellitus
Phase 4
Active, not recruiting
23
2026-04
"Efficacy and Safety of Linaclotide in Chronic Constipation"
Md Mehedi Shahriar · Chronic Idiopathic Constipation · Irritable Bowel Syndrome (IBS-C)
Phase 4
Not yet recruiting
90
2026-02
Linaclotide for Colonoscopy Bowel Prep
University of Florida · Patients Scheduled for Colonoscopy
Phase 1 / Phase 2
Recruiting
10
2026-01
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.