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A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide

Study on Linaclotide for toddlers with constipation, checking effects and safety.

Recruiting
6-23 years
All
Phase 2

Functional constipation (FC) is a common issue for children, often caused by low fiber intake or not drinking enough fluids. This study will look at how well a drug called linaclotide works for treating FC in young children, aged 6 months to just under 2 years. Linaclotide is a medicine that helps with constipation by increasing fluid in the intestines to make it easier to have a bowel movement. Children will either get this medicine or a placebo (a harmless pill that looks like the medicine but has no active ingredients) for 4 weeks. Parents will prepare the medicine at home and give it once a day. The study will take place at about 25 locations worldwide with about 30 children participating.

  • Study lasts 4 weeks with regular clinic visits.
  • Participants have a 50% chance of receiving placebo.
  • Parents will prepare and give medicine daily.

Before joining, children must have certain symptoms like fewer than 3 bowel movements a week. They should not have other medical issues that could affect the study, like celiac disease or Down's syndrome. The study involves medical check-ups, blood tests, and keeping track of any side effects or changes in symptoms.

Study details
    Functional Constipation

NCT05760313

AbbVie

16 March 2025

Step 1 Get in touch with the nearest study center
Entire USA
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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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