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
Study identification
- NCT ID
- NCT05652205
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- AbbVie
- Industry
- Enrollment
- 123 participants
Conditions and interventions
Interventions
- Linaclotide Drug
- Placebo for Linaclotide Drug
Drug
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 May 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05652205 live on ClinicalTrials.gov.