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)
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to evaluate dose response of the safety and efficacy of linaclotide for the treatment of functional constipation (FC), in children age 6-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Participants age 6-11 years will receive oral liquid formulation and participants 12-17 years will receive solid oral capsule or liquid oral solution. Children ages 6-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of FC.
Study identification
- NCT ID
- NCT02559570
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 173 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
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 Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02559570 live on ClinicalTrials.gov.