Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Constipation
Functional Constipation
Irritable Bowel Syndrome
Irritable Bowel Syndrome With Constipation
Syndrome

Clinical Trial Details

NCT number	NCT04166058
Study type	Interventional
Source	AbbVie
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	November 19, 2019
Completion date	June 5, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04506801` - The Effect of Probiotics on Functional Constipation in the Elderly	N/A
Completed	`NCT04620161` - A Proof of Concept Study of Pradigastat in Patients With Functional Constipation	Phase 2
Active, not recruiting	`NCT02361749` - Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation	Phase 4
Completed	`NCT03054805` - The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation	Phase 4
Not yet recruiting	`NCT01913665` - The Effect of Bifidobacterium Lactis and Inulin on Functional Constipation	N/A
Completed	`NCT01622972` - Mode of Action of Moviprep	Phase 4
Completed	`NCT01348152` - Effect of TU-100 in Patients With Functional Constipation	Phase 2
Completed	`NCT01212146` - Probiotic-enriched Artichoke in Functional Constipation	N/A
Completed	`NCT04231162` - Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation	N/A
Not yet recruiting	`NCT03639142` - Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children	Phase 3
Recruiting	`NCT04918329` - Functional Digestive Disorders Observatory
Completed	`NCT02592200` - Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women	N/A
Completed	`NCT03707002` - Effect of scFOS on Increase in Stool Frequency in Constipated People	N/A
Recruiting	`NCT06083311` - The Efficacy of a Probiotic for Functional Constipation (FC)	N/A
Completed	`NCT04110145` - Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation	Phase 2
Recruiting	`NCT06196073` - Visceral Osteopathy in Functional Constipation	N/A
Completed	`NCT04026113` - Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)	Phase 3
Completed	`NCT02359396` - A Randomized, Open-label, Three-arm Study of MZRW on Tolerability, Exposure and Pharmacokinetics	Phase 1
Completed	`NCT01847950` - Effects of scFOS on Stool Frequency in People With Functionnal Constipation	N/A
Recruiting	`NCT01274793` - Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy	Phase 1