A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation

PHASE2TerminatedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

November 1, 2015

Primary Completion Date

August 30, 2019

Study Completion Date

August 30, 2019

Conditions
Irritable Bowel Syndrome With Constipation
Interventions
DRUG

Linaclotide Dose A

DRUG

Linaclotide Dose B

DRUG

Linaclotide Dose C

DRUG

Linaclotide Approved Adult Dose

DRUG

Matching Placebo

Trial Locations (48)

10032

Columbia University Medical Center and Morgan Stanley Children's Hospital of New York, New York

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

15236

Preferred Primary Care Physicians, Inc., Pittsburgh

15478

Montgomery Medical Inc., Smithfield

15683

Frontier Clinical Research, LLC, Scottdale

19134

St. Christopher's Hospital for Children, Philadelphia

20910

Certified Research Consultants Virgo/Carter Pediatrics, Silver Spring

23507

Children's Hospital of The King's Daughters, Norfolk

24013

Virginia Tech Carilion School of Medicine Pediatric Gastroenterology, Roanoke

27203

Asheboro Research Associates - Site 022, Asheboro

27609

Capital Pediatrics and Adolescent Center PLLC, Raleigh

29414

Coastal Pediatric Research, Charleston

29464

Coastal Pediatrics Associates, Mt. Pleasant

30281

Sleepcare Clinical Research Institute, Stockbridge

30342

Children's Center for Digestive Health Care LLC, Atlanta

33135

Advanced Medical Research Center, Miami

39202

GI Associates and Endoscopy Center, Jackson

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45414

Ohio Pediatric Research Association, Dayton

46202

Riley Hospital for Children at Indiana University Health, Indianapolis

53066

Aurora Health Care, Aurora Medical Center in Summit, Summit

61602

Methodist Medical Center, Peoria

64108

Children's Mercy Hospital, Kansas City

67205

Heartland Research Associates, LLC, Wichita

68010

Boys Town National Research Hospital, Boys Town

68505

Midwest Children Health Research Institute, Lincoln

68516

Midwest Children Health Research Institute, Lincoln

71118

Willis-Knighton Physician Network, Shreveport

71913

HealthStar Research, LLC, Hot Springs

72212

Applied Research Center of Arkansas, Little Rock

73103

IPS Research Company, Oklahoma City

75165

ClinPoint Trials, Waxahachie

76104

Cook Children's Medical Center, Fort Worth

77030

Texas Children's Hospital/Baylor College Medicine, Houston

77090

Houston Clinical Research Associates, Houston

78215

Sun Research Institute, San Antonio

90017

ACTCA, Inc, Los Angeles

90027

Children's Hospital Los Angeles, Los Angeles

90723

Center for Clinical Trials, LLC, Paramount

92626

WCCT Global, LLC, Costa Mesa

92805

Advanced Research Center - Site 069, Anaheim

92879

Kindred Medical Institute for Clinical Trials, LLC, Corona

94143

University of California at San Francisco, San Francisco

98405

MultiCare Institute for Research and Innovation, Tacoma

07962

Goryeb Children's Hospital, Morristown

02903

Rhode Island Hospital, Providence

N6A 5W9

Children's Hospital of Western Ontario, London

L4L 4Y7

Physician's Clinical Research Inc., Vaughan

Sponsors
All Listed Sponsors
collaborator

Ironwood Pharmaceuticals, Inc.

INDUSTRY

lead

Forest Laboratories

INDUSTRY