Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
← catalyst calendarSponsored by AbbVie (industry) · ABBV — their whole pipeline →. With Ironwood Pharmaceuticals, Inc..
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
381actual
Sites
72
Countries
Canada, Israel, Netherlands +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 | 2019-11-19 | actual | When the study began enrolling |
| Primary completion | 2025-06-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-05 | actual | The whole study's end, after follow-up |
| First posted | 2019-11-18 | 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
Conditions
- Irritable Bowel Syndrome With Constipation
- Functional Constipation
Interventions
- Drug: Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers)
- Drug: Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
Primary outcome
what the primary-completion date above is the date OFNumber of Participants With Treatment-Emergent Adverse Events (TEAEs).
measured From first dose of study drug until 30 days following last dose of study drug [up to 24 weeks (FC participants) or 52 weeks (IBS-C participants)].
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2021-04-30 · 1.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2022-07-19 · 467 KB · SAP_001.pdf
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