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)

A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide in Pediatric Participants, Ages 6 to 17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) and of Linaclotide Versus Placebo in Pediatric Participants With Functional Constipation (FC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 438 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for child/adolescent FC. The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 μg or 290 μg daily) in pediatric participants 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent IBS and modified Rome III criteria for child/adolescent FC.

Conditions

• Functional Constipation
• Irritable Bowel Syndrome With Constipation

Interventions

Type	Name	Description
DRUG	Linaclotide	Oral capsule (For participants who do not wish to take the dose as a capsule, a sprinkled dose may be prepared)
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2019-10-01
• Primary completion: 2024-05-20
• Completion: 2024-05-29
• First posted: 2019-07-19
• Last updated: 2024-11-26
• Results posted: 2024-11-26

Locations

115 sites across 14 countries: United States, Belgium, Bulgaria, Canada, Estonia, Germany, Israel, Italy, Netherlands, Poland, Puerto Rico, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study