A Lactation Study in Women Who Are Breastfeeding or Pumpi... | NCT02220348

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

NCT02220348

Sponsor

Forest Laboratories

Status

Completed

Last Update Posted

Dec 19, 2020Actual

Enrollment

7Actual

Phase

Phase 1

Conditions

Breast Feeding
Constipation
Irritable Bowel Syndrome

Interventions

linaclotide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2014Actual

Primary Completion Date

May 31, 2019Actual

Completion Date

May 31, 2019Actual

First Submitted Date

Aug 12, 2014

First Submission Date that Met QC Criteria

Aug 18, 2014

First Posted Date

Aug 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2020

Last Update Posted Date

Dec 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
linaclotide	Experimental	Linaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration	Drug: linaclotide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
linaclotide	Drug		linaclotide	Linzess

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk		From Baseline (Day 1) to Day 4

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ramesh Boinpally, PhD	Forest Research Institute, an affiliate of Allergan plc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Iowa		Iowa City	Iowa	52242	United States
Digestive Disease Specialists Inc (DDSI)

Condition Browse Module

MeSH Terms

ID	Term
D001942	Breast Feeding
D003248	Constipation
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D005247	Feeding Behavior
D001519	Behavior
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C523483	linaclotide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided