A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
Public ClinicalTrials.gov record NCT05652205. 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 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation (FC) With a 24-week Open-label Treatment Extension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients, ages 2 to 5, who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. All participants in Part 2 will receive linaclotide. Approximately 116 participants aged 2 to 5 years with FC will be enrolled in this study at around 45 sites worldwide. Participants will receive daily doses of oral Linaclotide capsules or matching placebo for 12 weeks in Part 1 of the study. In Part 2, the open label long-term safety extension, participants with FC who completed study intervention in Part 1 of Study M21-572 or the Phase 2 Study LIN-MD-67 will receive linaclotide for 24 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT05652205
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 123 participants
Conditions and interventions
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
- Dec 28, 2022
- Primary completion
- Sep 1, 2025
- Completion
- Sep 1, 2025
- Last update posted
- May 13, 2026
2022 – 2025
United States locations
- U.S. sites
- 38
- U.S. states
- 22
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| G & L Research, LLC /ID# 250658 | Foley | Alabama | 36535 | — |
| Velocity Clinical Research - Phoenix /ID# 266280 | Phoenix | Arizona | 85006 | — |
| HealthStar Research of Hot Springs PLLC /ID# 249481 | Hot Springs | Arkansas | 71913 | — |
| Applied Research Center of Arkansas /ID# 249764 | Little Rock | Arkansas | 72212-4187 | — |
| Advanced Research Center /ID# 249412 | Anaheim | California | 92805 | — |
| Kindred Medical Institute - Corona /ID# 249485 | Corona | California | 92879-3104 | — |
| Medical Ctr for Clin Research /ID# 254386 | San Diego | California | 92108 | — |
| Prohealth Research Center /ID# 249420 | Doral | Florida | 33166 | — |
| KIDZ Medical Services - Hollywood /ID# 250823 | Hollywood | Florida | 33021-6030 | — |
| Nemours Children's Health System /ID# 250881 | Jacksonville | Florida | 32207 | — |
| Kissimmee Clinical Research /ID# 252206 | Kissimmee | Florida | 34741 | — |
| South Miami Medical & Research Group Inc. /ID# 249418 | Miami | Florida | 33155 | — |
| Valencia Medical & Research Center /ID# 250452 | Miami | Florida | 33165 | — |
| Palmetto Professional Research /ID# 250875 | Miami | Florida | 33172 | — |
| South Florida Research Ph I-IV /ID# 252350 | Miami Springs | Florida | 33166-7225 | — |
| Velocity Clinical Research Macon /ID# 266516 | Macon | Georgia | 31210-6583 | — |
| Rophe Adult & Pediatric Medicine /ID# 250663 | Union City | Georgia | 30291 | — |
| Michael W. Simon, MD, PSC /ID# 250664 | Lexington | Kentucky | 40517 | — |
| Velocity Clinical Research - Lafayette /ID# 266751 | Lafayette | Louisiana | 70508 | — |
| Frederick County Pediatrics /ID# 249483 | New Market | Maryland | 21774-6154 | — |
| Michigan Center of Medical Research /ID# 251088 | Farmington Hills | Michigan | 48334 | — |
| MNGI Digestive Health, P. A. /ID# 249676 | Minneapolis | Minnesota | 55413-2195 | — |
| Velocity Clinical Research- Hastings Nebraska /ID# 252132 | Hastings | Nebraska | 68901-2640 | — |
| Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 250876 | Newark | New Jersey | 07103-2425 | — |
| Univ NC Chapel Hill /ID# 252044 | Chapel Hill | North Carolina | 27514-4220 | — |
| UH Cleveland Medical Center /ID# 250893 | Cleveland | Ohio | 44106 | — |
| IPS Research Company /ID# 250822 | Oklahoma City | Oklahoma | 73106 | — |
| Frontier Clinical Research, LLC - Scottdale /ID# 250656 | Scottdale | Pennsylvania | 15683 | — |
| Frontier Clinical Research - Smithfield /ID# 250657 | Smithfield | Pennsylvania | 15478 | — |
| Coastal Pediatric Research - West Ashley B /ID# 249413 | Charleston | South Carolina | 29414 | — |
| Tribe Clinical Research LLC /ID# 255656 | Greenville | South Carolina | 29607-4021 | — |
| Coastal Pediatric Research - Summerville /ID# 249423 | Summerville | South Carolina | 29486 | — |
| Tullahoma Pediatrics /ID# 250892 | Tullahoma | Tennessee | 37388 | — |
| Houston Clinical Research Associates /ID# 250779 | Houston | Texas | 77090-2633 | — |
| Prime Clinical Research - Mansfield - East Broad Street /ID# 266236 | Mansfield | Texas | 76063 | — |
| ClinPoint Trials /ID# 250448 | Waxahachie | Texas | 75165-1430 | — |
| Carilion Medical Center /ID# 249790 | Roanoke | Virginia | 24014 | — |
| Frontier Clinical Research - Kingwood /ID# 251154 | Kingwood | West Virginia | 26537-9797 | — |
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 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05652205, 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 May 13, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05652205 live on ClinicalTrials.gov.