Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)

PHASE3CompletedINTERVENTIONAL
Enrollment

438

Participants

Timeline

Start Date

October 1, 2019

Primary Completion Date

May 20, 2024

Study Completion Date

May 29, 2024

Conditions
Functional ConstipationIrritable Bowel Syndrome With Constipation
Interventions
DRUG

Linaclotide

Oral capsule (For participants who do not wish to take the dose as a capsule, a sprinkled dose may be prepared)

DRUG

Placebo

Matching placebo

Trial Locations (115)

726

San Juan Bautista School of Medicine /ID# 232913, Caguas

1090

Duplicate_UZ Brussel /ID# 232875, Brussels

3320

MHATSv.Ivan Rilski /ID# 232831, Kozloduy

4001

University Hospital Plovdiv /ID# 232775, Tsentar

5400

Medical center 1 Sevlievo /ID# 232915, Sevlievo

7002

UMHAT Kanev /ID# 233102, Ruse

10467

The Children's Hospital at Montefiore /ID# 232638, The Bronx

10468

Advantage Clinical Trials /ID# 233117, The Bronx

10617

Merelahe Family Doctors Centre /ID# 232881, Tallinn

Al Mare Perearstikeskus /ID# 232879, Harjumaa

15208

The Baruch Padeh Medical Center Poriya /ID# 232889, Tiberias

15478

Frontier Clinical Research /ID# 233116, Smithfield

15683

Frontier Clinical Research, LLC - Scottdale /ID# 233129, Scottdale

20910

Virgo Carter Pediatrics /ID# 232693, Silver Spring

21029

Vinnytsya National Medical University Departement of Pediatrics No.1 /ID# 232890, Vinnytsia

23606

Health Research of Hampton Roads, Inc. (HRHR) /ID# 233056, Newport News

23851

Office of Maria Ona /ID# 232700, Franklin

24014

Carilion Medical Center /ID# 232999, Roanoke

27834

East Carolina University - Brody School of Medicine /ID# 233062, Greenville

28625

PMG Research of Piedmont Healthcare-Statesville /ID# 233162, Statesville

29414

Coastal Pediatric Research - West Ashley B /ID# 232816, Charleston

29486

Coastal Pediatric Research - Summerville /ID# 232814, Summerville

30083

Clinical Trials Specialist Inc /ID# 232802, Stone Mountain

30281

Clinical Research Institute /ID# 232833, Stockbridge

Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 232940, Stockbridge

30291

Rophe Adult and Pediatric Medicine/SKYCRNG /ID# 232800, Union City

30315

Treken Primary Care /ID# 232796, Atlanta

30342

Children's Ctr Digestive, US /ID# 233070, Atlanta

30513

River Birch Research Alliance /ID# 233122, Blue Ridge

31096

Duplicate_Rambam Health Care Campus Ruth Rappaport Children's Hospital /ID# 232892, Haifa

32207

Nemours Children's Health System /ID# 233127, Jacksonville

32765

Oviedo Medical Research /ID# 232830, Oviedo

32825

Pediatric & Adult Research Center /ID# 232819, Orlando

33013

Amedica Research Institute Inc /ID# 232809, Hialeah

33144

Elite Clinical Research /ID# 232801, Miami

33155

My Preferred Research LLC /ID# 233119, Miami

South Miami Medical & Research Group Inc. /ID# 232803, Miami

33165

Valencia Medical & Research Center /ID# 232813, Miami

33166

Prohealth Research Center /ID# 232805, Doral

33172

Dolphin Medical Research /ID# 232815, Doral

34125

Duplicate_Klinikum Kassel /ID# 233029, Kassel

35205

Central Research Associates /ID# 233124, Birmingham

36535

G & L Research, LLC /ID# 233139, Foley

36571

The Center for Clinical Trials Inc. /ID# 232755, Saraland

37232

Monroe-Carell Jr. Children's Hospital at Vanderbilt /ID# 232659, Nashville

37760

Accellacare of Knoxville /ID# 232663, Jefferson City

38305

The Jackson Clinic, PA /ID# 232998, Jackson

39232

GI associates and Endoscopy Ce /ID# 233123, Flowood

40517

Michael W. Simon, MD, PSC /ID# 232966, Lexington

41014

Instituto Hispalense Pediatria /ID# 232793, Seville

49064

Communal Nonprofit Enterprise City Childrens Clinical Hospital 6 of Dnipro C /ID# 232863, Dnipro

50410

Kliiniliste Uuringute Keskus /ID# 232883, Tartu

61093

Kharkiv Regional Childrens Clinical Hospital Gastroent. Centre Kharkiv Natl. Me /ID# 232867, Kharkiv

63044

Private Practice - Dr. Craig Spiegel /ID# 232707, Bridgeton

66160

Univ Kansas Med Ctr /ID# 232645, Kansas City

67114

Alliance for Multispecialty Research LLC /ID# 232681, Newton

71913

HealthStar Research of Hot Springs PLLC /ID# 232757, Hot Springs

72211

Preferred Research Partners /ID# 233023, Little Rock

73104

Univ Oklahoma HSC /ID# 233067, Oklahoma City

73106

IPS Research Company /ID# 233081, Oklahoma City

75093

AIM Trials /ID# 232934, Plano

75243

Oak Cliff Research Company LLC /ID# 232729, Dallas

76104

Cook Children's Med. Center /ID# 233066, Fort Worth

77051

Cullen Research /ID# 232726, Houston

77061

Synergy Group US LLC /ID# 232669, Houston

77459

Synergy Group US LLC /ID# 232670, Missouri City

78215

Sun Research Institute /ID# 233005, San Antonio

78550

Valley Institute of Research /ID# 232674, Harlingen

79059

Municipal Nonprofit Enterprise Lviv City Children's Clinical Hospital /ID# 232851, Lviv

80012

Lynn Institute of Denver /ID# 233137, Aurora

84790

Chrysalis Clinical Research /ID# 232690, St. George

90201

Alliance Research Institute /ID# 232754, Bell Gardens

90723

Center for Clinical Trials LLC /ID# 232781, Paramount

91031

Shaare Zedek Medical Center /ID# 233092, Jerusalem

91120

Hadassah Hebrew University Hospital - Ein Kerem /ID# 232865, Jerusalem

91304

Alliance Research Institute Llc /Id# 232637, Canoga Park

92108

Medical Ctr for Clin Research /ID# 233004, San Diego

92703

Paragon Rx Clinical Inc /ID# 232752, Santa Ana

92805

Advanced Research Center /ID# 233121, Anaheim

92879

Kindred Medical Institute, LLC /ID# 233042, Corona

98405

Duplicate_Multicare Institute for Research and Innovation /ID# 233010, Tacoma

4920235

Schneider Children's Medical Center /ID# 233064, Petah Tikva

5265601

The Chaim Sheba Medical Center /ID# 232986, Ramat Gan

5822000

The Edith Wolfson Medical Center /ID# 233134, Ashkelon

72212-4187

Applied Research Center of Arkansas /ID# 233135, Little Rock

20010-2916

Children's National Medical Center /ID# 232655, Washington D.C.

34102-5430

Advanced Research for Health Improvement /ID# 233161, Naples

32827-7884

Nemours Children's Hospital /ID# 232919, Orlando

30342-1605

Children's Healthcare of Atlanta - Ferry Rd /ID# 233015, Atlanta

70806-7631

Meridian Research - Baton Rouge /ID# 232954, Baton Rouge

55413-2195

MNGI Digestive Health, P. A. /ID# 232920, Minneapolis

39150-2024

David M. Headley, MD, P.A. /ID# 233153, Port Gibson

07018

Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 232783, East Orange

87102-4517

University of New Mexico /ID# 233011, Albuquerque

10032-3725

Columbia Univ Medical Center /ID# 233094, New York

02903

Rhode Island Hospital /ID# 233112, Providence

77017-2337

Vilo Research Group Inc /ID# 233155, Houston

77099-4307

Pioneer Research Solutions - Houston /ID# 233006, Houston

75165-1430

ClinPoint Trials /ID# 232978, Waxahachie

23220-4459

Clinical Research Partners, LLC /ID# 233026, Richmond

25701-3656

Marshall University Medical Center /ID# 232952, Huntington

T6G 2B7

University of Alberta Hospital /ID# 233147, Edmonton

N6A 5W9

London Health Sciences Center- University Hospital /ID# 233068, London

L3Y 5G8

Duplicate_SKDS Research Inc. /ID# 233000, Newmarket

N7T 4X3

Bluewater Clinical Research Group Inc /ID# 232772, Sarnia

L4A 1H2

Stouffville Medical Centre /ID# 232774, Stouffville

00189

Sant?Andrea University Hospital /ID# 232825, Rome

1105 AZ

Duplicate_Academisch Medisch Centrum /ID# 232895, Amsterdam

3079 DZ

Maasstad Ziekenhuis /ID# 233003, Rotterdam

8025 AB

Isala /ID# 233031, Zwolle

85-094

Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza /ID# 232898, Bydgoszcz

80-803

Klinika Pediatrii Gastroenterologii Alergologii i Zywienia Dzieci GUM /ID# 232900, Gdansk

10-561

Poradnia Gastroenterologiczna /ID# 232899, Olsztyn

35-302

Korczowski Bartosz Gabinet Lekarski /ID# 232821, Rzeszow

TN24 0LZ

William Harvey Hospital /ID# 232806, Ashford

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Ironwood Pharmaceuticals, Inc.

INDUSTRY

lead

AbbVie

INDUSTRY