~4 spots leftby Sep 2025

Linaclotide for Pediatric Constipation

Recruiting at 36 trial locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AbbVie
Must not be taking: Laxatives, Suppositories, Enemas
Disqualifiers: Celiac, Cystic fibrosis, Hypothyroidism, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions

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

AI

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

The person filling out the eDiary for me can read, understand it, and will be trained.
I meet the criteria for functional constipation based on my symptoms.
You have bowel movements less than two times a week without using any medications to help you go to the bathroom in the past day.
See 6 more

Exclusion Criteria

I have celiac disease or it's suspected but not confirmed by a biopsy.
I have cystic fibrosis.
My thyroid condition is stable and has been treated consistently for the last 3 months.
See 13 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral solution of linaclotide or placebo once daily for 4 weeks

4 weeks
Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

  • Linaclotide (Guanylate Cyclase-C Agonist)
  • Placebo (Other)
Trial OverviewThe study tests Linaclotide against a placebo in treating pediatric functional constipation. Initially, different dosages are given consecutively in three groups; later participants are randomly assigned to either the drug or placebo. The treatment involves daily oral solution intake over four weeks at various global sites.
Participant Groups
5Treatment groups
Experimental Treatment
Group I: Part 2, PlaceboExperimental Treatment1 Intervention
Participants will receive placebo capsules mixed with water and administered orally in Part 2 for 4 weeks.
Group II: Part 2, LinaclotideExperimental Treatment1 Intervention
Participants will receive Linaclotide capsules mixed with water and administered orally in Part 2 for 4 weeks.
Group III: Part 1, Linaclotide Dose CExperimental Treatment1 Intervention
Linaclotide Dose C capsules, mixed with water and administered orally, once daily for 4 weeks
Group IV: Part 1, Linaclotide Dose BExperimental Treatment1 Intervention
Linaclotide Dose B capsules, mixed with water and administered orally, once daily for 4 weeks
Group V: Part 1, Linaclotide Dose AExperimental Treatment1 Intervention
Linaclotide Dose A capsules, mixed with water and administered orally, once daily for 4 weeks

Linaclotide is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as Linzess for:
  • 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

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Ironwood Pharmaceuticals, Inc.

Industry Sponsor

Trials
42
Recruited
17,100+

Findings from Research

Linaclotide (Linzess) is an effective treatment for patients suffering from irritable bowel syndrome with constipation and chronic idiopathic constipation, helping to relieve symptoms.
The medication works by increasing fluid secretion in the intestines and accelerating bowel movements, which can significantly improve the quality of life for those affected.
Linaclotide (Linzess) for Irritable Bowel syndrome With Constipation and For Chronic Idiopathic Constipation.Thomas, RH., Allmond, K.[2022]
Linaclotide is effective for treating moderate to severe irritable bowel syndrome with constipation, showing significant improvements in symptoms compared to placebo, with a combined response rate of 12.6% to 22.8%.
The only notable adverse effect of linaclotide is diarrhea, making it a relatively safe option for patients who do not respond to other treatments for their symptoms.
Linaclotide in the treatment of patients with irritable bowel syndrome and constipation - analysis of an opportunity.Carballo, F.[2019]
Linaclotide has been shown to provide more frequent relief from constipation-related symptoms compared to a placebo in two clinical trials involving about 1600 patients, lasting 3 to 6 months.
However, it can cause significant gastrointestinal side effects, particularly diarrhea, which affected 20% of patients and led to discontinuation in about 10%, raising concerns about its safety and the lack of evidence showing it is more effective than other laxatives.
Linaclotide. A bacterial enterotoxin derivative with a laxative action, nothing more.[2017]

References

Linaclotide (Linzess) for Irritable Bowel syndrome With Constipation and For Chronic Idiopathic Constipation. [2022]
Linaclotide in the treatment of patients with irritable bowel syndrome and constipation - analysis of an opportunity. [2019]
Linaclotide. A bacterial enterotoxin derivative with a laxative action, nothing more. [2017]
Effect of 5 days linaclotide on transit and bowel function in females with constipation-predominant irritable bowel syndrome. [2022]
Economic Evaluation of Linaclotide for the Treatment of Adult Patients With Chronic Idiopathic Constipation in the United States. [2017]
Linaclotide: a review of its use in the treatment of irritable bowel syndrome with constipation. [2022]
[Pharmacological and clinical profile of linaclotide (Linzess&#174;), a novel therapeutic agent for irritable bowel syndrome with constipation and chronic constipation]. [2019]
The pharmacokinetics, pharmacodynamics, clinical efficacy, safety and tolerability of linaclotide. [2017]
Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis. [2018]