Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, with Functional Constipation (FC) with a 24-week Open-label Treatment Extension

This research is a stage three clinical trial, which means it's one of the final steps before a medicine might become widely available. It's focused on children aged 2 to 5 years old who experience ongoing functional constipation. Researchers want to compare a medicine called Linaclotide with a 'dummy' medicine (placebo) to see if it helps these children have more regular bowel movements. They will also look at how much effort children need to go to the toilet, how watery or firm their poo is, and if they have accidents. The study will last for 24 weeks, with the first part being a comparison between the medicine and the dummy, followed by a period where all children may receive the active medicine.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Abbvie Deutschland GmbH & Co. KG

Enrolment target

Start

07 Aug 2023

Functional Constipation

What is this study about?

This clinical trial is designed to understand how a medicine called Linaclotide works for very young children, specifically those between 2 and 5 years old, who have a common problem called functional constipation. Functional constipation means that a child has trouble going to the toilet regularly, or their poo is hard to pass, even though there's no other medical reason for it. It's a stage three study, which means it’s a big, important step to see if this medicine is safe and effective enough to be approved for tiny tots.

The main goal of this study is to see if Linaclotide helps children go to the toilet more often and more regularly over a 12-week period, compared to a sugar pill (called a placebo). Parents or guardians will be key because they will keep track of their child's bowel movements. Beyond just how often they go, the researchers will also be watching other important things. This includes how firm or soft their child's poo is, whether they have to strain a lot when trying to go, and if they have any accidents, especially for children who are already potty trained.

After this initial 12-week comparison, there's a longer 24-week period where all children in the study will get the active medicine, Linaclotide. This extended part helps researchers gather more information on the medicine's long-term effects and safety. The insights from this study could help doctors better support families dealing with constipation in young children, which can be a tricky and uncomfortable issue for both the child and their parents.

Key takeaways

This study is for children aged 2-5 with ongoing constipation.
It tests a medicine called Linaclotide against a dummy medicine (placebo).
The main aim is to see if it helps children go to the toilet more regularly and easily.
Parents will play a key role in tracking their child's bowel habits.
The study lasts about 36 weeks in total, with regular clinic visits.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for children aged between 2 and 5 years old. Both boys and girls can take part. To be suitable, your child must have been diagnosed with functional constipation.

There might be other health reasons or medicines your child is taking that could mean they can't join the study, but these will be discussed in detail by the study team. The doctors and nurses involved will check all these details carefully to make sure the study is safe and right for your child.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 2 and 5 years old?
Has a doctor told you that your child has functional constipation?
Is your child currently not taking any medications that might interfere with a constipation study?
Are you able to attend regular clinic visits and record your child's bowel movements for several months?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, you would first go through a screening process to check if they are suitable. If eligible, your child would be randomly assigned to either receive the study medicine (Linaclotide) or a dummy medicine (placebo) for the first 12 weeks. This is a "double-blind" study, meaning neither you nor the study team will know which one your child is getting.

Throughout these 12 weeks, you would be asked to closely monitor and record details about your child's bowel movements, such as how often they go, the consistency of their poo, and if they strain. You'd also bring your child for regular visits to the clinic so the study doctors can check their health and see how they are responding to the medication. After this initial 12-week period, all children in the study will then receive the actual Linaclotide medicine for an additional 24 weeks. The total time your child would be involved in the study is around 36 weeks, including regular check-ups and assessments.

Potential risks and benefits

Taking part in a study like this could potentially help your child if the medicine works well for their constipation. It also contributes to medical knowledge that could benefit many other children in the future. However, new medicines can have unexpected side effects, and your child might experience some discomfort or reactions, or the medicine might not work for them. If your child receives the placebo, their constipation might not improve during the first 12 weeks. You are free to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands
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Unverified
Bulgaria

Common questions

What is 'functional constipation'?

It's when a child has trouble going to the toilet regularly or has hard and painful poos, but there's no other straightforward medical cause found for it.

What is a 'placebo'?

A placebo is a dummy medicine that looks exactly like the real medicine but contains no active drug. It helps researchers see if the real medicine is truly effective.

Will I know if my child is getting the real medicine?

No, for the first 12 weeks, neither you nor the study doctors will know if your child is getting Linaclotide or the placebo. This is to make the study fair.

How long will my child be in the study?

The study lasts for about 36 weeks in total. This includes the initial 12 weeks where they might get the real medicine or the placebo, followed by 24 weeks where all children will receive the active medicine.

Can I take my child out of the study if I change my mind?

Yes, you can withdraw your child from the study at any point, and it won't affect their regular medical care.