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)

  • STATUS
    Recruiting
  • End date
    Jul 11, 2023
  • participants needed
    426
  • sponsor
    Allergan
Updated on 26 September 2021
incontinence
laxative
posturing

Summary

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

Details
Condition Irritable Bowel Syndrome With Constipation, Functional Constipation
Treatment Placebo, Linaclotide 72 μg, Linaclotide 72 μg (FC Participants), Placebo (FC Participants), Linaclotide 145 μg (IBS-C Participants), Linaclotide 290 μg (IBS-C Participants)
Clinical Study IdentifierNCT04026113
SponsorAllergan
Last Modified on26 September 2021

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