Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-03-05 @ 11:30 PM
Study NCT ID:
NCT04166058
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2019-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
Sponsor:
AbbVie
Organization:
Study Overview
Official Title:
A Phase 3, Open-label, Long-term Safety Study of Oral Linaclotide Administered to Pediatric Participants With Functional Constipation (FC) or Irritable Bowel Syndrome With Constipation (IBS-C)
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
LIN-MD-66 is a Phase 3 open-label study with 24 weeks (Functional Constipation participants) or 52 weeks (Irritable bowel syndrome with constipation participants) of linaclotide exposure that will enroll pediatric participants (6-17 years of age) with FC or IBS-C who completed study intervention in studies LIN-MD-62, LIN-MD-63, orLIN-MD-64 based on the individual study criteria.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-001955-38 | EUDRACT_NUMBER | None | View |