Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
Public ClinicalTrials.gov record NCT04110145. 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 Phase 2, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending, Multidose Study to Evaluate the Safety and Efficacy of Linaclotide in Pediatric Participants (Age 2 to 5 Years) With Functional Constipation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the dose response, safety, and efficacy of linaclotide when compared with placebo in pediatric participants, 2 to 5 years of age, with Functional Constipation.
Study identification
- NCT ID
- NCT04110145
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 35 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 5 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
- Oct 14, 2019 (Actual)
- Primary completion
- Apr 20, 2021 (Actual)
- Completion
- Apr 20, 2021 (Actual)
- Last update posted
- Apr 26, 2022
2019 – 2021
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Research Associates, Inc | Birmingham | Alabama | 35205 | — |
| HealthStar Research | Hot Springs | Arkansas | 71913 | — |
| Preferred Clinical Research Partners | Little Rock | Arkansas | 72211 | — |
| Advanced Research Center | Anaheim | California | 92805 | — |
| Kindred Medical Institute for Clinical Trials, LLC | Corona | California | 92879 | — |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | — |
| Prohealth Research Center | Doral | Florida | 33166 | — |
| South Miami Medical & Research Group, Inc. | Miami | Florida | 33155 | — |
| River Birch Research Alliance, LLC | Blue Ridge | Georgia | 30513 | — |
| SleepCare Research Institute, Inc. | Stockbridge | Georgia | 30281 | — |
| Virgo Carter Pediatrics | Silver Spring | Maryland | 20910 | — |
| Minnesota Gastroenterology PA | Minneapolis | Minnesota | 55413 | — |
| David M. Headley, MD, P.A. | Port Gibson | Mississippi | 39150 | — |
| Foundation Pediatrics Med Clinical Research Partners, LLC | East Orange | New Jersey | 07108 | — |
| Advantage Clinical Trials | The Bronx | New York | 10468 | — |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | — |
| Coastal Pediatric Research | Mt. Pleasant | South Carolina | 29464 | — |
| Clinical Research Partners, LLC | Richmond | Virginia | 23220 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04110145, 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 Apr 26, 2022 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04110145 live on ClinicalTrials.gov.