NCT02559817

A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, A Multicenter, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) (ie, Fulfill Rome III Criteria for Child/Adolescent IBS and Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C.

Conditions

• Irritable Bowel Syndrome With Constipation

Interventions

Type	Name	Description
DRUG	Linaclotide Dose A
DRUG	Linaclotide Dose B
DRUG	Linaclotide Dose C
DRUG	Linaclotide Approved Adult Dose
DRUG	Matching Placebo

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-08-30
• Completion: 2019-08-30
• First posted: 2015-09-24
• Last updated: 2020-12-28
• Results posted: 2020-12-28

Locations

48 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study