ClinicalTrials.gov record
Completed Phase 2 Interventional Results available

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)

ClinicalTrials.gov ID: NCT02559570

Public ClinicalTrials.gov record NCT02559570. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 22, 2026, 6:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)

Study identification

NCT ID
NCT02559570
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Forest Laboratories
Industry
Enrollment
173 participants

Conditions and interventions

Interventions

  • LIN 145 µg Drug
  • LIN Dose A Drug
  • LIN Dose B Drug
  • LIN Dose C Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
6 Years to 17 Years
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2, 2015
Primary completion
Apr 19, 2018
Completion
May 28, 2018
Last update posted
Jun 18, 2019

2015 – 2018

United States locations

U.S. sites
60
U.S. states
27
U.S. cities
54
Facility City State ZIP Site status
HealthStar Research, LLC Hot Springs Arkansas 71913
Applied Research Center of Arkansas Little Rock Arkansas 72212
Advanced Research Center Anaheim California 92805
Kindred Medical Institute for Clinical Trials, LLC Corona California 92879
WCCT Global, LLC Costa Mesa California 92626
Ark Clinical Research Long Beach California 90806
ACTCA, Inc Los Angeles California 90017
Children's Hospital Los Angeles Los Angeles California 90017
Orange County Research Institute Ontario California 91762
Center for Clinical Trials, LLC Paramount California 90723
UCSD Rady Children's Hospital San Diego California 92123
University of California at San Francisco San Francisco California 94143
Ventura Clinical Trials Ventura California 93003
Colorado Springs Health Partners, HCP-Clinical Research, LLC Colorado Springs Colorado 80922
Nova Southeastern University Fort Lauderdale Florida 33314
Homestead Research Institute Homestead Florida 33030
RM Medical Research Homestead Florida 33030
Advanced Medical Research Center Miami Florida 33135
SCORE Physician Alliance, LLC St. Petersburg Florida 33710
Children's Center for Digestive Health Care LLC Atlanta Georgia 30342
Sleepcare Clinical Research Institute Stockbridge Georgia 30281
Riley Hospital for Children at Indiana University Health Indianapolis Indiana 46202
Heartland Research Associates, LLC Wichita Kansas 67205
Kentucky Pediatric/ Adult Research Bardstown Kentucky 40004
Kosair Children's Hospital - Pediatric Clinical Research Unit Louisville Kentucky 40202
Michael W. Simon, MD, PSC Nicholasville Kentucky 40356
Willis-Knighton Physician Network Shreveport Louisiana 71118
University of Maryland Children's Hospital Baltimore Maryland 21201
Massachusetts General Hospital Boston Massachusetts 02114
University Of Minnesota Minneapolis Minnesota 55455
GI Associates and Endoscopy Center Jackson Mississippi 39232
Craig A. Speigel, MD Bridgeton Missouri 63044
Midwest Children Health Research Institute Lincoln Nebraska 68505
Midwest Children Health Research Institute Lincoln Nebraska 68516
Goryeb Children's Hospital Morristown New Jersey 07962
Columbia University Medical Center and Morgan Stanley New York New York 10032
Asheboro Research Associates Asheboro North Carolina 27203
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599
Capital Pediatrics and Adolescent Center PLLC Raleigh North Carolina 27609
Ohio Pediatric Research Association Dayton Ohio 45414
IPS Research Company Oklahoma City Oklahoma 73103
Pediatric Care Specialists Johnstown Pennsylvania 15904
St. Christopher's Hospital for Children Philadelphia Pennsylvania 19134
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224
Preferred Primary Care Physicians, Inc. Pittsburgh Pennsylvania 15236
Frontier Clinical Research, LLC Scottdale Pennsylvania 15683
Montgomery Medical Inc. Smithfield Pennsylvania 15478
Rhode Island Hospital Providence Rhode Island 02903
Coastal Pediatric Research Charleston South Carolina 29414
Coastal Pediatrics Associates Mt. Pleasant South Carolina 29464
Cook Children's Medical Center Fort Worth Texas 76104
Texas Children's Hospital/Baylor College Medicine Houston Texas 77030
Houston Clinical Research Associates Houston Texas 77090
Sun Research Institute San Antonio Texas 78215
Southwest Children's Research Associates, P.A. San Antonio Texas 78229
ClinPoint Trials Waxahachie Texas 75165
Foothill Family Clinic South / J. Lewis Research, Inc. Salt Lake City Utah 84121
Pediatric Specialists of Virginia Fairfax Virginia 22031
Virginia Tech Carilion School of Medicine Pediatric Roanoke Virginia 24013
Seattle Children's Hospital Seattle Washington 98105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02559570, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 18, 2019 · Synced Apr 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02559570 live on ClinicalTrials.gov.

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