A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation

Study Identifier
M21-572
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2022-501946-31-00
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, Bulgarian, Dutch

Study Details

Medical Condition
  • Constipation
  • Study Drug
  • Placebo for Linaclotide
  • Linaclotide
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    2 - 5 Years

    Protocol Summary

    Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC.

    Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients, ages 2 to 5, who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. All participants in Part 2 will receive linaclotide. Approximately 116 participants aged 2 to 5 years with FC will be enrolled in this study at around 45 sites worldwide.

    Participants will receive daily doses of oral Linaclotide capsules or matching placebo for 12 weeks in Part 1 of the study. In Part 2, the open label long-term safety extension, participants with FC who completed study intervention in Part 1 of Study M21-572 or the Phase 2 Study LIN-MD-67 will receive linaclotide for 24 weeks.

    There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    G & L Research, LLC /ID# 250658
    Foley, Alabama, United States, 36535
    Status
    Not applicable
    Location
    Velocity Clinical Research - Phoenix /ID# 266280
    Phoenix, Arizona, United States, 85006
    Status
    Not applicable
    Location
    HealthStar Research of Hot Springs PLLC /ID# 249481
    Hot Springs, Arkansas, United States, 71913
    Status
    Not applicable
    Location
    Applied Research Center of Arkansas /ID# 249764
    Little Rock, Arkansas, United States, 72212-4187
    Status
    Not applicable
    Location
    Advanced Research Center /ID# 249412
    Anaheim, California, United States, 92805
    Status
    Not applicable
    Location
    Kindred Medical Institute - Corona /ID# 249485
    Corona, California, United States, 92879-3104
    Status
    Not applicable
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