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Clinical Trial 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 Functional Constipation (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 Irritable Bowel Syndrome (IBS) and modified Rome III criteria for child/adolescent Functional Constipation (FC).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04026113
Study type Interventional
Source AbbVie
Contact
Status Completed
Phase Phase 3
Start date October 1, 2019
Completion date May 29, 2024

See also
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