A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide

PHASE2CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

April 27, 2023

Primary Completion Date

June 9, 2025

Study Completion Date

June 9, 2025

Conditions
Functional Constipation
Interventions
DRUG

Linaclotide

Capsule; oral

DRUG

Placebo

Capsule; oral

Trial Locations (38)

1407

Acibadem City Clinic Tokuda University Hospital EAD /ID# 251232, Sofia

1606

Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 251229, Sofia

4002

UMHAT Sveti Georgi /ID# 250808, Plovdiv

4032

Debreceni Egyetem-Klinikai Kozpont /ID# 250793, Debrecen

7002

UMHAT Kanev /ID# 248931, Rousse

9000

Nova Clinic /ID# 249023, Varna

10000

Klinicki bolnicki centar Sestre milosrdnice /ID# 252798, Zagreb

Klinicki bolnicki centar Zagreb /ID# 252796, Zagreb

Klinika za dječje bolesti Zagreb /ID# 252792, Zagreb

11000

Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 252485, Belgrade

University Children's Hospital 'Tirsova' /ID# 252483, Belgrade

21000

Institute for Child and Youth Health Care of Vojvodina /ID# 252482, Novi Sad

29414

Coastal Pediatric Research - West Ashley B /ID# 248693, Charleston

29486

Coastal Pediatric Research - Summerville /ID# 253534, Summerville

31000

Klinicki bolnicki centar Osijek /ID# 252795, Osijek

33155

South Miami Medical & Research Group Inc. /ID# 248765, Miami

33165

Valencia Medical & Research Center /ID# 251533, Miami

33166

Prohealth Research Center /ID# 248696, Doral

42283

HELIOS Klinikum Wuppertal /ID# 249022, Wuppertal

48149

Universitaetsklinikum Muenster /ID# 251965, Münster

48334

Michigan Center of Medical Research /ID# 253536, Farmington Hills

70508

Velocity Clinical Research - Lafayette /ID# 263873, Lafayette

71913

HealthStar Research of Hot Springs PLLC /ID# 251553, Hot Springs

76063

Prime Clinical Research - Mansfield - East Broad Street /ID# 262947, Mansfield

85006

Velocity Clinical Research - Phoenix /ID# 263871, Phoenix

91301

Kinderarztpraxis Dr. Froehlich /ID# 252050, Forchheim

92805

Advanced Research Center /ID# 248763, Anaheim

92879-3104

Kindred Medical Institute - Corona /ID# 251535, Corona

20016-4300

Velocity Clinical Research Washington DC /ID# 263872, Washington D.C.

31210-6583

Velocity Clinical Research Macon /ID# 263959, Macon

21774-6154

Frederick County Pediatrics /ID# 251555, New Market

68901-2640

Velocity Clinical Research- Hastings Nebraska /ID# 260932, Hastings

77090-2633

Houston Clinical Research Associates /ID# 261571, Houston

75165-1430

ClinPoint Trials /ID# 251534, Waxahachie

E1 2ES

Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 252298, London

WC1N 3HZ

Great Ormond Street Children's Hospital /ID# 253333, London

NR4 7UY

Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 252299, Norwich

DY1 2HQ

Russells Hall Hospital /ID# 252660, Dudley

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Ironwood Pharmaceuticals, Inc.

INDUSTRY

lead

AbbVie

INDUSTRY