Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C

Study Identifier
LIN-MD-66
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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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, Hebrew, Dutch

Study Details

Medical Condition
  • Irritable Bowel Syndrome (IBS)
  • Constipation
  • Study Drug
  • Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers)
  • Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    6 - 18 Years

    Protocol Summary

    LIN-MD-66 is a Phase 3 open-label study with 24 weeks (Functional Constipation participants) or 52 weeks (Irritable bowel syndrome with constipation participants) of linaclotide exposure that will enroll pediatric participants (6-17 years of age) with FC or IBS-C who completed study intervention in studies LIN-MD-62, LIN-MD-63, or LIN-MD-64 based on the individual study criteria.

    Study Locations

    Location
    Status
    Location
    Central Research Associates /ID# 237953
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    G & L Research, LLC /ID# 238093
    Foley, Alabama, United States, 36535
    Status
    Not applicable
    Location
    The Center for Clinical Trials Inc. /ID# 234605
    Saraland, Alabama, United States, 36571
    Status
    Not applicable
    Location
    HealthStar Research of Hot Springs PLLC /ID# 234608
    Hot Springs, Arkansas, United States, 71913
    Status
    Not applicable
    Location
    Preferred Research Partners /ID# 237109
    Little Rock, Arkansas, United States, 72211
    Status
    Not applicable
    Location
    Applied Research Center of Arkansas /ID# 238069
    Little Rock, Arkansas, United States, 72212-4187
    Status
    Not applicable
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