Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C

PHASE3CompletedINTERVENTIONAL
Enrollment

389

Participants

Timeline

Start Date

November 19, 2019

Primary Completion Date

June 5, 2025

Study Completion Date

June 5, 2025

Conditions
Irritable Bowel Syndrome With ConstipationFunctional Constipation
Interventions
DRUG

Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 completers)

Participants whom are between the ages of 7-11 years old at their time of enrollment will be assigned a dose (72 μg or 145 μg) based on their weight. Randomized doses (145 μg or 290 μg) will be assigned to participants whom are 12-17 years old at the time of enrollment.

DRUG

Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)

Participants whom are between the ages of 6-11 years old at their time of enrollment will be assigned a dose of 72 μg. Randomized doses (72 μg or 145 μg) will be assigned to participants whom are 12-17 years old at the time of enrollment.

Trial Locations (72)

10032

Columbia University Irving Medical Center /ID# 235686, New York

10468

Advantage Clinical Trials /ID# 237932, The Bronx

15208

The Baruch Padeh Medical Center Poriya /ID# 234768, Tiberias

15478

Duplicate_Frontier Clinical Research /ID# 237923, Smithfield

15683

Frontier Clinical Research, LLC - Scottdale /ID# 238022, Scottdale

20910

Virgo Carter Pediatrics /ID# 234518, Silver Spring

23606

Health Research of Hampton Roads, Inc. (HRHR) /ID# 237252, Newport News

23851

Office of Maria Ona /ID# 234539, Franklin

27834

East Carolina University - Brody School of Medicine /ID# 237509, Greenville

28625

PMG Research of Piedmont Healthcare-Statesville /ID# 238257, Statesville

29414

Coastal Pediatric Research - West Ashley B /ID# 234678, Charleston

29486

Coastal Pediatric Research - Summerville /ID# 234674, Summerville

30281

Clinical Research Institute /ID# 234702, Stockbridge

Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236342, Stockbridge

30315

Treken Primary Care /ID# 234645, Atlanta

30342

Children's Ctr Digestive, US /ID# 237574, Atlanta

30513

River Birch Research Alliance /ID# 237963, Blue Ridge

32207

Nemours Childrens Specialty Care /ID# 237991, Jacksonville

32765

Oviedo Medical Research /ID# 234692, Oviedo

32825

Pediatric & Adult Research Center /ID# 234681, Orlando

33013

Amedica Research Institute Inc /ID# 234666, Hialeah

33144

Elite Clinical Research /ID# 234651, Miami

33155

My Preferred Research LLC /ID# 237943, Miami

South Miami Medical & Research Group Inc. /ID# 234654, Miami

33165

Valencia Medical & Research Center /ID# 234671, Miami

33166

Prohealth Research Center /ID# 234659, Doral

33172

Dolphin Medical Research /ID# 234676, Doral

35205

Central Research Associates /ID# 237953, Birmingham

36535

G & L Research, LLC /ID# 238093, Foley

36571

The Center for Clinical Trials Inc. /ID# 234605, Saraland

37760

Accellacare of Knoxville /ID# 234462, Jefferson City

38305

The Jackson Clinic, PA /ID# 236772, Jackson

39232

GI associates and Endoscopy Ce /ID# 237969, Flowood

40517

Michael W. Simon, MD, PSC /ID# 236516, Lexington

63044

Private Practice - Dr. Craig Spiegel /ID# 234545, Bridgeton

67214

KU Wichita Center for Clinical Research /ID# 234500, Wichita

71913

HealthStar Research of Hot Springs PLLC /ID# 234608, Hot Springs

72211

Preferred Research Partners /ID# 237109, Little Rock

73104

Univ Oklahoma HSC /ID# 237546, Oklahoma City

73106

IPS Research Company /ID# 237669, Oklahoma City

75093

AIM Trials /ID# 236364, Plano

76104

Cook Children's Med. Center /ID# 237536, Fort Worth

77051

Cullen Research /ID# 234482, Houston

78215

Sun Research Institute /ID# 236932, San Antonio

78550

Valley Institute of Research /ID# 234475, Harlingen

80012

Lynn Institute of Denver /ID# 238086, Aurora

84790

Duplicate_Chrysalis Clinical Research /ID# 234515, St. George

90723

Center for Clinical Trials LLC /ID# 234629, Paramount

91120

Hadassah Hebrew University Hospital - Ein Kerem /ID# 234735, Jerusalem

92108

Medical Ctr for Clin Research /ID# 236911, San Diego

92805

Advanced Research Center /ID# 237960, Anaheim

92879

Kindred Medical Institute, LLC /ID# 237367, Corona

98405

Duplicate_Multicare Institute for Research and Innovation /ID# 236979, Tacoma

5265601

The Chaim Sheba Medical Center /ID# 236760, Ramat Gan

72212-4187

Applied Research Center of Arkansas /ID# 238069, Little Rock

20010-2916

Children's National Medical Center /ID# 234417, Washington D.C.

34102-5430

Advanced Research for Health Improvement /ID# 238253, Naples

32827-7884

Nemours Children's Hospital /ID# 234429, Orlando

30342-1605

Children's Healthcare of Atlanta - Ferry Rd /ID# 237005, Atlanta

55413-2195

MNGI Digestive Health, P. A. /ID# 234437, Minneapolis

39150-2024

David M. Headley, MD, P.A. /ID# 238216, Port Gibson

07018

Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 234566, East Orange

87102-4517

University of New Mexico /ID# 236983, Albuquerque

02903

Rhode Island Hospital /ID# 237861, Providence

77017-2337

Vilo Research Group Inc /ID# 238228, Houston

77099-4307

Pioneer Research Solutions - Houston /ID# 236935, Houston

75165-1430

ClinPoint Trials /ID# 236615, Waxahachie

23220-4459

Clinical Research Partners, LLC /ID# 237158, Richmond

N6A 5W9

London Health Sciences Center- University Hospital /ID# 234309, London

N7T 4X3

Bluewater Clinical Research Group Inc /ID# 234618, Sarnia

L4A 1H2

Stouffville Medical Centre /ID# 234619, Stouffville

1105 AZ

Duplicate_Academisch Medisch Centrum /ID# 237116, Amsterdam

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Ironwood Pharmaceuticals, Inc.

INDUSTRY

lead

AbbVie

INDUSTRY