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
Public ClinicalTrials.gov record NCT02559817. 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, A Multicenter, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) (ie, Fulfill Rome III Criteria for Child/Adolescent IBS and Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 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 IBS-C.
Study identification
- NCT ID
- NCT02559817
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 101 participants
Conditions and interventions
Conditions
Interventions
- Linaclotide Dose A Drug
- Linaclotide Dose B Drug
- Linaclotide Dose C Drug
- Linaclotide Approved Adult Dose Drug
- Matching Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 7 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 1, 2015 (Actual)
- Primary completion
- Aug 30, 2019 (Actual)
- Completion
- Aug 30, 2019 (Actual)
- Last update posted
- Dec 28, 2020
2015 – 2019
United States locations
- U.S. sites
- 46
- U.S. states
- 24
- U.S. cities
- 42
| 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 - Site 069 | Anaheim | California | 92805 | — |
| Kindred Medical Institute for Clinical Trials, LLC | Corona | California | 92879 | — |
| WCCT Global, LLC | Costa Mesa | California | 92626 | — |
| ACTCA, Inc | Los Angeles | California | 90017 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | — |
| University of California at San Francisco | San Francisco | California | 94143 | — |
| Advanced Medical Research Center | Miami | Florida | 33135 | — |
| Children's Center for Digestive Health Care LLC | Atlanta | Georgia | 30342 | — |
| Sleepcare Clinical Research Institute | Stockbridge | Georgia | 30281 | — |
| Methodist Medical Center | Peoria | Illinois | 61602 | — |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | 46202 | — |
| Heartland Research Associates, LLC | Wichita | Kansas | 67205 | — |
| Willis-Knighton Physician Network | Shreveport | Louisiana | 71118 | — |
| Certified Research Consultants Virgo/Carter Pediatrics | Silver Spring | Maryland | 20910 | — |
| GI Associates and Endoscopy Center | Jackson | Mississippi | 39202 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Boys Town National Research Hospital | Boys Town | Nebraska | 68010 | — |
| 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 Children's Hospital of New York | New York | New York | 10032 | — |
| Asheboro Research Associates - Site 022 | Asheboro | North Carolina | 27203 | — |
| Capital Pediatrics and Adolescent Center PLLC | Raleigh | North Carolina | 27609 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Ohio Pediatric Research Association | Dayton | Ohio | 45414 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | — |
| 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 | — |
| ClinPoint Trials | Waxahachie | Texas | 75165 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Virginia Tech Carilion School of Medicine Pediatric Gastroenterology | Roanoke | Virginia | 24013 | — |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | — |
| Aurora Health Care, Aurora Medical Center in Summit | Summit | Wisconsin | 53066 | — |
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 NCT02559817, 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 Dec 28, 2020 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02559817 live on ClinicalTrials.gov.