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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501946-31-00
Acronym
M21-572
Enrollment
14
Registered
2023-08-07
Start date
2024-02-29
Completion date
2025-06-30
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Constipation

Brief summary

Change from baseline in 12-week SBM frequency rate (SBMs/week) observed by the primary caregiver during the double-blind study intervention period.

Detailed description

Change from baseline in 12-week stool consistency observed by the primary caregiver during the double-blind study intervention period, Change from baseline in 12-week straining observed by the primary caregiver during the double-blind study intervention period, Change from baseline in 12-week proportion of days with fecal incontinence during the double-blind study intervention period (for subjects who have acquired toileting skills during daytime and nighttime or acquired toileting skills during daytime only)

Interventions

DRUGLinaclotide

Sponsors

Abbvie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Secondary

MeasureTime frame
Change from baseline in 12-week stool consistency observed by the primary caregiver during the double-blind study intervention period, Change from baseline in 12-week straining observed by the primary caregiver during the double-blind study intervention period, Change from baseline in 12-week proportion of days with fecal incontinence during the double-blind study intervention period (for subjects who have acquired toileting skills during daytime and nighttime or acquired toileting skills during daytime only)

Primary

MeasureTime frame
Change from baseline in 12-week SBM frequency rate (SBMs/week) observed by the primary caregiver during the double-blind study intervention period.

Countries

Bulgaria, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026