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Linaclotide

Clinical trials are investigating Linaclotide in children with functional constipation. These studies look at safety, tolerability, and how well the treatment works in different age groups, including infants and young children. The trials compare Linaclotide with placebo and measure bowel movement frequency, stool form, and straining.

Table of Contents

Trial overview

These clinical trials studied Linaclotide in children with functional constipation, which means ongoing constipation without another clear cause in the trial records.[1][2] The studies were designed to check safety, tolerability, and signs of benefit in young children.[1][2]

Both studies were completed and focused on pediatric patients, not adults.[1][2] One study enrolled infants and toddlers, and the other enrolled preschool-aged children.[1][2]

Who was studied

The first trial studied pediatric subjects aged 6 months to less than 2 years with functional constipation.[1] This is a very young age group, so the study measured results reported by a legally authorized representative, parent, guardian, or caregiver.[1]

The second trial studied pediatric subjects aged 2 to 5 years with functional constipation who met modified Rome IV criteria, which are study rules used to define childhood constipation.[2] In this trial, the primary caregiver observed the main bowel movement outcome during the double-blind part of the study.[2]

Study designs and phases

The first study was a Phase 2 dose finding study, which means it tried to identify a dose that was tolerable, safe, and effective over 4 weeks.[1] Phase 2 studies often help researchers choose the best dose for later testing.[1]

The second study was a Phase 3 trial, which compared Linaclotide with placebo over 12 weeks in a larger pediatric group.[2] It also included a long-term safety part for children who had already finished the main study part or a related study.[2]

The first study included several study interventions, including oral Linaclotide doses of 9 micrograms, 18 micrograms, and 36 micrograms, plus placebo and other comparator interventions listed in the trial record.[1] The second study used oral Linaclotide 72 micrograms and placebo.[2]

What was measured in the trials

The main outcome in the first study was the change from baseline in 4-week spontaneous bowel movement frequency, stool consistency, and straining during the study period.[1] Baseline means the starting point before treatment began.[1]

The main outcome in the second study was the change from baseline in 12-week spontaneous bowel movement frequency during the double-blind study period.[2] The study also looked at long-term safety after the main treatment period.[2]

  • SBM frequency: how often a child has bowel movements on their own, measured each week.[1][2]
  • Stool consistency: how soft or hard the stool is, measured with the Bristol Stool Form Scale in the younger age study.[1]
  • Straining: how much pushing or effort is needed during bowel movements.[1]
  • Safety: whether the study treatment could be used without causing major problems in the trial setting.[1][2]
  • Efficacy: how well the study treatment worked for the constipation outcomes being measured.[1][2]

Trial-by-trial details

Trial 2022-501947-34-00 was a completed Phase 2 interventional study with 29 enrolled participants.[1] It studied children 6 months to less than 2 years old with functional constipation and aimed to find a tolerable, safe, and effective Linaclotide dose for a 4-week treatment period.[1]

The trial’s main measurements were change in bowel movement frequency, stool consistency, and straining over 4 weeks.[1] The study also included oral Linaclotide doses of 9, 18, and 36 micrograms, along with placebo, as listed in the record.[1]

NCT05652205 was a completed Phase 3 interventional study with 116 enrolled participants.[2] It studied children ages 2 to 5 years with functional constipation and compared 12 weeks of Linaclotide with placebo.[2]

This study also had a long-term safety part for children who completed the main study or a related study called LIN-MD-67.[2] Its main outcome was the change in spontaneous bowel movement frequency during the double-blind treatment period.[2]

What these trials show about the research program

Together, these studies show that Linaclotide has been tested in more than one young pediatric age group with functional constipation.[1][2] The research moved from a smaller Phase 2 dose-finding study in infants and toddlers to a larger Phase 3 placebo-controlled study in preschool children.[1][2]

The trial records focus on practical outcomes that matter to families, such as how often the child has bowel movements, how the stool looks, and whether the child strains.[1][2] This makes the studies useful for understanding whether Linaclotide may help children with constipation in real-life care settings.[1][2]

Trial ID Phase Condition studied Status Enrollment
2022-501947-34-00 Phase 2 Functional constipation in children 6 months to less than 2 years old Completed 29
NCT05652205 Phase 3 Functional constipation in children ages 2 to 5 years Completed 116

FAQ

  • What condition are the Linaclotide trials studying? The trials are studying functional constipation in children. This means the child has ongoing trouble passing stools, based on the study criteria.
  • Who can take part in these trials? One trial enrolled children 6 months to less than 2 years old, and another enrolled children 2 to 5 years old. Each study used specific medical criteria, such as modified Rome IV criteria in the older age group.
  • What phases are these trials? The studies are Phase 2 and Phase 3 trials. Phase 2 looks at dose finding, safety, and early signs of benefit, while Phase 3 compares treatment with placebo in a larger group.
  • What are the trials measuring? The main measures are stool frequency, stool consistency, and straining. Stool frequency means how often bowel movements happen, and stool consistency means how soft or hard the stool is.
  • Are the studies finished? Yes, both trials listed are completed. One studied infants and toddlers, and the other studied children ages 2 to 5 years.

Ongoing Clinical Trials on Linaclotide

  • Study on Linaclotide for Treating Functional Constipation in Children Aged 6 Months to Less Than 2 Years

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Germany Hungary

  • Study on Linaclotide for Treating Functional Constipation in Children Aged 2 to 5 Years

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria The Netherlands

Glossary

  • Functional Constipation: A type of constipation not explained by another clear disease in the trial records. Children may have hard, infrequent, or difficult bowel movements.
  • Phase 2: An early clinical trial phase that often looks at dose finding, safety, and early signs that a treatment may work.
  • Phase 3: A later trial phase that usually compares a treatment with placebo in a larger group of people.
  • Placebo: A look-alike treatment with no active study drug. It is used to compare results fairly.
  • Interventional Study: A study where researchers give a treatment or intervention and then measure the results.
  • Enrollment: The number of participants who joined the study.
  • Primary Outcome: The main result the study is designed to measure.
  • SBM Frequency: How often a person has spontaneous bowel movements, meaning bowel movements that happen on their own.
  • Bristol Stool Form Scale: A scale used to describe stool shape and consistency, from very hard to very loose.
  • Straining: Pushing hard or having trouble during a bowel movement.
  • Double-blind: A study design where the child, family, and study team do not know who receives the active treatment or placebo.
  • Long-term Safety: Information about how safe a treatment is when used for a longer time.

References