Linaclotide for Pediatric Constipation
Trial Summary
What is the purpose of this trial?
This trial tests linaclotide, a medication that may help young children with constipation by making their stools softer and easier to pass. The study involves children aged 6 months to less than 2 years who struggle with constipation.
Will I have to stop taking my current medications?
The trial requires that participants stop using any laxatives before the study begins, but it does not specify about other medications. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug Linaclotide for pediatric constipation?
Linaclotide has been shown to be effective in adults for conditions like irritable bowel syndrome with constipation and chronic idiopathic constipation, where it increases stool frequency and decreases stool consistency. Although these studies are in adults, they suggest that Linaclotide may help with constipation by increasing intestinal fluid secretion and speeding up bowel movements.12345
Is linaclotide safe for treating constipation in children?
Linaclotide has been studied in adults for conditions like irritable bowel syndrome with constipation, and the most common side effect is diarrhea, which can sometimes be severe. It is generally well tolerated, but about 10% of patients stopped using it due to gastrointestinal issues. There is no safety data for its use during pregnancy, and it should be used cautiously in people prone to fluid and electrolyte imbalances.12346
How is the drug Linaclotide unique for treating pediatric constipation?
Linaclotide is unique because it is a guanylate cyclase-C receptor agonist that works by increasing fluid secretion in the intestines, which helps to relieve constipation. Unlike some other treatments, it acts locally in the gut and has a low risk of systemic side effects due to its minimal absorption into the bloodstream.16789
Research Team
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
This trial is for children aged 6 months to less than 2 years with functional constipation. They must meet certain criteria like having a history of hard bowel movements or infrequent defecation, and their parents must be able to use an eDiary for tracking. Children with conditions like celiac disease, cystic fibrosis, untreated hypothyroidism, chromosomal disorders, or any condition affecting drug absorption cannot participate.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral solution of linaclotide or placebo once daily for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Linaclotide (Guanylate Cyclase-C Agonist)
- Placebo (Other)
Linaclotide is already approved in Canada for the following indications:
- Chronic idiopathic constipation
- Irritable bowel syndrome with constipation (IBS-C)
- Functional constipation in pediatric patients 6 to 17 years of age
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Ironwood Pharmaceuticals, Inc.
Industry Sponsor