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 Identifier
M21-862
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2022-501947-34-00
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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, German, Croatian, Hungarian

Study Details

Medical Condition
  • Constipation
  • Study Drug
  • Linaclotide
  • Placebo
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    6 - 23 Months

    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 who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 3 groups, which occur consecutively. Each group receives a different dosage of linaclotide. In Part 2 of the study, participants will be randomly assigned to receive either linaclotide or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Up to 30 and at least 18 pediatric participants 6 months to less than 2 years of age with FC will be enrolled in the study at approximately 38 sites worldwide.

    Participants will receive oral solution of linaclotide prepared from capsule by parent/guardian once daily for 4 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 regular 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
    Velocity Clinical Research - Phoenix /ID# 263871
    Phoenix, Arizona, United States, 85006
    Status
    Not applicable
    Location
    HealthStar Research of Hot Springs PLLC /ID# 251553
    Hot Springs, Arkansas, United States, 71913
    Status
    Not applicable
    Location
    Advanced Research Center /ID# 248763
    Anaheim, California, United States, 92805
    Status
    Not applicable
    Location
    Kindred Medical Institute - Corona /ID# 251535
    Corona, California, United States, 92879-3104
    Status
    Not applicable
    Location
    Velocity Clinical Research Washington DC /ID# 263872
    Washington D.C., District of Columbia, United States, 20016-4300
    Status
    Not applicable
    Location
    Prohealth Research Center /ID# 248696
    Doral, Florida, United States, 33166
    Status
    Not applicable
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