A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide
Public ClinicalTrials.gov record NCT05760313. 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 Dose Finding Study Evaluating the Safety and Efficacy of Linaclotide in Pediatric Subjects 6 Months to Less Than 2 Years of Age With Functional Constipation (FC).
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 who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 3 groups, which occur consecutively. Each group receives a different dosage of linaclotide. In Part 2 of the study, participants will be randomly assigned to receive either linaclotide or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Up to 30 and at least 18 pediatric participants 6 months to less than 2 years of age with FC will be enrolled in the study at approximately 38 sites worldwide. Participants will receive oral solution of linaclotide prepared from capsule by parent/guardian once daily for 4 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 regular 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
- NCT05760313
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 19 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months to 23 Months
- 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
- Apr 26, 2023
- Primary completion
- Jun 8, 2025
- Completion
- Jun 8, 2025
- Last update posted
- Jan 5, 2026
2023 – 2025
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Velocity Clinical Research - Phoenix /ID# 263871 | Phoenix | Arizona | 85006 | — |
| HealthStar Research of Hot Springs PLLC /ID# 251553 | Hot Springs | Arkansas | 71913 | — |
| Advanced Research Center /ID# 248763 | Anaheim | California | 92805 | — |
| Kindred Medical Institute - Corona /ID# 251535 | Corona | California | 92879-3104 | — |
| Velocity Clinical Research Washington DC /ID# 263872 | Washington D.C. | District of Columbia | 20016-4300 | — |
| Prohealth Research Center /ID# 248696 | Doral | Florida | 33166 | — |
| South Miami Medical & Research Group Inc. /ID# 248765 | Miami | Florida | 33155 | — |
| Valencia Medical & Research Center /ID# 251533 | Miami | Florida | 33165 | — |
| Velocity Clinical Research Macon /ID# 263959 | Macon | Georgia | 31210-6583 | — |
| Velocity Clinical Research - Lafayette /ID# 263873 | Lafayette | Louisiana | 70508 | — |
| Frederick County Pediatrics /ID# 251555 | New Market | Maryland | 21774-6154 | — |
| Michigan Center of Medical Research /ID# 253536 | Farmington Hills | Michigan | 48334 | — |
| Velocity Clinical Research- Hastings Nebraska /ID# 260932 | Hastings | Nebraska | 68901-2640 | — |
| Coastal Pediatric Research - West Ashley B /ID# 248693 | Charleston | South Carolina | 29414 | — |
| Coastal Pediatric Research - Summerville /ID# 253534 | Summerville | South Carolina | 29486 | — |
| Houston Clinical Research Associates /ID# 261571 | Houston | Texas | 77090-2633 | — |
| Prime Clinical Research - Mansfield - East Broad Street /ID# 262947 | Mansfield | Texas | 76063 | — |
| ClinPoint Trials /ID# 251534 | Waxahachie | Texas | 75165-1430 | — |
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 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05760313, 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 Jan 5, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05760313 live on ClinicalTrials.gov.