Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)

Study Identifier
LIN-MD-64
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
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English, Dutch, Estonian, Hebrew, Italian, Ukrainian

Study Details

Medical Condition
  • Constipation
  • Irritable Bowel Syndrome (IBS)
  • Study Drug
  • Linaclotide
  • Placebo
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    6 - 17 Years

    Protocol Summary

    The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for child/adolescent FC. The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 μg or 290 μg daily) in pediatric participants 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent IBS and modified Rome III criteria for child/adolescent FC.

    Study Locations

    Location
    Status
    Location
    Central Research Associates /ID# 233124
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    G & L Research, LLC /ID# 233139
    Foley, Alabama, United States, 36535
    Status
    Not applicable
    Location
    The Center for Clinical Trials Inc. /ID# 232755
    Saraland, Alabama, United States, 36571
    Status
    Not applicable
    Location
    HealthStar Research of Hot Springs PLLC /ID# 232757
    Hot Springs, Arkansas, United States, 71913
    Status
    Not applicable
    Location
    Preferred Research Partners /ID# 233023
    Little Rock, Arkansas, United States, 72211
    Status
    Not applicable
    Location
    Applied Research Center of Arkansas /ID# 233135
    Little Rock, Arkansas, United States, 72212-4187
    Status
    Not applicable
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