A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)

PHASE2CompletedINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

November 3, 2015

Primary Completion Date

April 20, 2018

Study Completion Date

May 29, 2018

Conditions
Functional Constipation in Children Ages 6-17 Years
Interventions
DRUG

Placebo

Participants received matching placebo LIN liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.

DRUG

LIN Dose A

Participants received LIN 9 or 18 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.

DRUG

LIN Dose B

Participants received LIN 18 or 36 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.

DRUG

LIN Dose C

Participants received LIN 36 or 72 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.

DRUG

LIN 145 µg

Participants received LIN 145 µg, liquid solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.

Trial Locations (62)

10032

Columbia University Medical Center and Morgan Stanley, 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

15904

Pediatric Care Specialists, Johnstown

19134

St. Christopher's Hospital for Children, Philadelphia

21201

University of Maryland Children's Hospital, Baltimore

22031

Pediatric Specialists of Virginia, Fairfax

24013

Virginia Tech Carilion School of Medicine Pediatric, Roanoke

27203

Asheboro Research Associates, Asheboro

27599

University of North Carolina at Chapel Hill, Chapel Hill

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

33030

Homestead Research Institute, Homestead

RM Medical Research, Homestead

33135

Advanced Medical Research Center, Miami

33314

Nova Southeastern University, Fort Lauderdale

33710

SCORE Physician Alliance, LLC, St. Petersburg

39232

GI Associates and Endoscopy Center, Jackson

40004

Kentucky Pediatric/ Adult Research, Bardstown

40202

Kosair Children's Hospital - Pediatric Clinical Research Unit, Louisville

40356

Michael W. Simon, MD, PSC, Nicholasville

45414

Ohio Pediatric Research Association, Dayton

46202

Riley Hospital for Children at Indiana University Health, Indianapolis

55455

University Of Minnesota, Minneapolis

63044

Craig A. Speigel, MD, Bridgeton

67205

Heartland Research Associates, LLC, Wichita

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

78229

Southwest Children's Research Associates, P.A., San Antonio

80922

Colorado Springs Health Partners, HCP-Clinical Research, LLC, Colorado Springs

84121

Foothill Family Clinic South / J. Lewis Research, Inc., Salt Lake City

90017

ACTCA, Inc, Los Angeles

Children's Hospital Los Angeles, Los Angeles

90723

Center for Clinical Trials, LLC, Paramount

90806

Ark Clinical Research, Long Beach

91762

Orange County Research Institute, Ontario

92123

UCSD Rady Children's Hospital, San Diego

92626

WCCT Global, LLC, Costa Mesa

92805

Advanced Research Center, Anaheim

92879

Kindred Medical Institute for Clinical Trials, LLC, Corona

93003

Ventura Clinical Trials, Ventura

94143

University of California at San Francisco, San Francisco

98105

Seattle Children's Hospital, Seattle

02114

Massachusetts General Hospital, Boston

07962

Goryeb Children's Hospital, Morristown

02903

Rhode Island Hospital, Providence

T6G 2B7

Stollery Children's Hospital, Edmonton

N6A 4G5

Children's Hospital of Western Ontario, London

Sponsors
All Listed Sponsors
collaborator

Ironwood Pharmaceuticals, Inc.

INDUSTRY

lead

Forest Laboratories

INDUSTRY