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
← catalyst calendarSponsored by AbbVie (industry) · ABBV — their whole pipeline →. With Ironwood Pharmaceuticals, Inc..
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
123actual
Sites
48
Countries
Bulgaria, Netherlands, United Kingdom +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-12-29 | actual | When the study began enrolling |
| Primary completion | 2025-09-02 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-09-02 | actual | The whole study's end, after follow-up |
| First posted | 2022-12-15 | actual | When this record first appeared on the registry |
| Results posted | 2026-05-14 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-05-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Functional Constipation (FC)
- Chronic Idiopathic Constipation (CIC)
Interventions
- Drug: Placebo for Linaclotide
- Drug: Linaclotide
Primary outcomes
what the primary-completion date above is the date OFChange From Baseline in 12-week Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) Observed by the Primary Caregiver During the Double-blind Study Intervention Period
measured Baseline to Week 12
Number of Participants With Treatment-Emergent Adverse Events
measured From the time of study drug administration until 30 days or 5 half-lives after the last dose, up to 126 days in Period 1 and 226 days in Period 2
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2025-02-20 · 4.4 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-04-02 · 484 KB · SAP_001.pdf
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