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

PHASE3CompletedINTERVENTIONAL
Enrollment

123

Participants

Timeline

Start Date

December 29, 2022

Primary Completion Date

September 2, 2025

Study Completion Date

September 2, 2025

Conditions
Functional Constipation (FC)Chronic Idiopathic Constipation (CIC)
Interventions
DRUG

Linaclotide

Capsule; oral

DRUG

Placebo for Linaclotide

Capsule; oral

Trial Locations (48)

1407

Acibadem City Clinic Tokuda University Hospital EAD /ID# 251234, Sofia

1606

Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 251233, Sofia

4001

University Hospital Plovdiv /ID# 250814, Tsentar

7002

UMHAT Kanev /ID# 250815, Rousse

9000

Nova Clinic /ID# 250816, Varna

15478

Frontier Clinical Research - Smithfield /ID# 250657, Smithfield

15683

Frontier Clinical Research, LLC - Scottdale /ID# 250656, Scottdale

24014

Carilion Medical Center /ID# 249790, Roanoke

29414

Coastal Pediatric Research - West Ashley B /ID# 249413, Charleston

29486

Coastal Pediatric Research - Summerville /ID# 249423, Summerville

30291

Rophe Adult & Pediatric Medicine /ID# 250663, Union City

32207

Nemours Children's Health System /ID# 250881, Jacksonville

33155

South Miami Medical & Research Group Inc. /ID# 249418, Miami

33165

Valencia Medical & Research Center /ID# 250452, Miami

33166

Prohealth Research Center /ID# 249420, Doral

33172

Palmetto Professional Research /ID# 250875, Miami

34741

Kissimmee Clinical Research /ID# 252206, Kissimmee

36535

G & L Research, LLC /ID# 250658, Foley

37388

Tullahoma Pediatrics /ID# 250892, Tullahoma

40517

Michael W. Simon, MD, PSC /ID# 250664, Lexington

44106

UH Cleveland Medical Center /ID# 250893, Cleveland

48334

Michigan Center of Medical Research /ID# 251088, Farmington Hills

70508

Velocity Clinical Research - Lafayette /ID# 266751, Lafayette

71913

HealthStar Research of Hot Springs PLLC /ID# 249481, Hot Springs

73106

IPS Research Company /ID# 250822, Oklahoma City

76063

Prime Clinical Research - Mansfield - East Broad Street /ID# 266236, Mansfield

85006

Velocity Clinical Research - Phoenix /ID# 266280, Phoenix

92108

Medical Ctr for Clin Research /ID# 254386, San Diego

92805

Advanced Research Center /ID# 249412, Anaheim

72212-4187

Applied Research Center of Arkansas /ID# 249764, Little Rock

92879-3104

Kindred Medical Institute - Corona /ID# 249485, Corona

33021-6030

KIDZ Medical Services - Hollywood /ID# 250823, Hollywood

33166-7225

South Florida Research Ph I-IV /ID# 252350, Miami Springs

31210-6583

Velocity Clinical Research Macon /ID# 266516, Macon

21774-6154

Frederick County Pediatrics /ID# 249483, New Market

55413-2195

MNGI Digestive Health, P. A. /ID# 249676, Minneapolis

68901-2640

Velocity Clinical Research- Hastings Nebraska /ID# 252132, Hastings

07103-2425

Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 250876, Newark

27514-4220

Univ NC Chapel Hill /ID# 252044, Chapel Hill

29607-4021

Tribe Clinical Research LLC /ID# 255656, Greenville

77090-2633

Houston Clinical Research Associates /ID# 250779, Houston

75165-1430

ClinPoint Trials /ID# 250448, Waxahachie

26537-9797

Frontier Clinical Research - Kingwood /ID# 251154, Kingwood

4818 CK

Amphia Ziekenhuis /ID# 251698, Breda

1105 AZ

Amsterdam UMC, locatie AMC /ID# 251295, Amsterdam

E1 2ES

Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 251179, London

DN2 5LT

Doncaster Royal Infirmary /ID# 252080, Armthorpe Road

DN33 2BA

Northern Licolnshire and Goole NHS Foundation Trust /ID# 252007, Grimsby

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Ironwood Pharmaceuticals, Inc.

INDUSTRY

lead

AbbVie

INDUSTRY