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
← catalyst calendarSponsored by AbbVie (industry) · ABBV — their whole pipeline →. With Ironwood Pharmaceuticals, Inc..
Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
19actual
Sites
38
Countries
Bulgaria, Croatia, Germany +4
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 | 2023-04-27 | actual | When the study began enrolling |
| Primary completion | 2025-06-09 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-09 | actual | The whole study's end, after follow-up |
| First posted | 2023-03-08 | actual | When this record first appeared on the registry |
| Results posted | 2026-01-06 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-01-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Functional Constipation
Interventions
- Drug: Linaclotide — also filed as Linzess
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFChange From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period
measured Baseline to Week 4
Change From Baseline in Stool Consistency (Bristol Stool Form Scale) During the Study Intervention Period
measured Baseline to Week 4
Change From Baseline in Straining During the Study Intervention Period
measured Baseline to Week 4
Number of Participants With Adverse Events (AEs)
measured Up to Week 5
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-11-25 · 3.9 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-05-17 · 452 KB · SAP_001.pdf
Permalink · ABBV's whole pipeline · Catalyst calendar · Every registered study · What changed