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)

Completed · Phase 3 · NCT04026113

Conditions: Functional Constipation, Irritable Bowel Syndrome With Constipation

Research payments reported, 2025: $66,448
U.S. investigators named: 9
Sites paid: 8
Planned or actual enrollment: 438

About the trial

Sponsor: AbbVie (with Ironwood Pharmaceuticals, Inc.)
Tested: Linaclotide (drug), Placebo (drug)
Dates: Started 2019-10-01; completion 2024-05-29
Results posted: Yes

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.

From ClinicalTrials.gov, last updated 2024-11-26. Full record, eligibility and contacts (opens in a new tab)

Industry funding

AbbVie Inc. reported $66,448 in research payments for this study in 2025 (24 payments).

Products named: Linzess

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.

At a glance

About the trial

Industry funding

U.S. investigators named on this study

Sites paid to run it