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).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501947-34-00

Acronym

M21-862

Enrollment

Registered

2023-10-09

Start date

2023-12-05

Completion date

2025-05-01

Last updated

2025-04-07

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

Conditions

Functional Constipation (FC)

Brief summary

Change from baseline in 4-week overall SBM frequency rate (SBMs/week) during the Study Intervention Period, Change from baseline in 4-week stool consistency (Bristol Stool Form Scale) reported by legally authorized representative (LAR)/parent/guardian/caregiver during the Study Intervention Period, Change from baseline in 4-week straining reported by LAR/parent/guardian/caregiver during the Study Intervention Period

Interventions

DRUGLinaclotide

DRUG-

DRUGLinaclotide Placebo

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline in 4-week overall SBM frequency rate (SBMs/week) during the Study Intervention Period, Change from baseline in 4-week stool consistency (Bristol Stool Form Scale) reported by legally authorized representative (LAR)/parent/guardian/caregiver during the Study Intervention Period, Change from baseline in 4-week straining reported by LAR/parent/guardian/caregiver during the Study Intervention Period	—

Measure

Time frame

—

Countries

Bulgaria, Croatia, Germany, Hungary

Outcome results

None listed

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