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NCT04166058 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Functional Constipation and Irritable Bowel Syndrome With Constipation, sponsored by AbbVie.

Completed
Registry status
Phase 3
Development phase
381
Enrollment target
20
Study locations

NCT04166058 is a Phase 3 study of Functional Constipation and Irritable Bowel Syndrome With Constipation that has completed, run by AbbVie. The registered enrollment target is 381 participants, above the 46-participant average among 4 other Functional Constipation trials with a reported enrollment target (728% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT04166058, a Phase 3 study of Functional Constipation and Irritable Bowel Syndrome With Constipation, has completed, sponsored by AbbVie.

COMPLETED
Registry status
Phase 3
Development phase
381 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Functional Constipation Irritable Bowel Syndrome With Constipation

Interventions

  • DRUG Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers)
  • DRUG Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)

Study Locations (20)

Florida

  • Prohealth Research Center /ID# 234659 - Doral
  • Dolphin Medical Research /ID# 234676 - Doral
  • Amedica Research Institute Inc /ID# 234666 - Hialeah
  • Nemours Childrens Specialty Care /ID# 237991 - Jacksonville
  • Elite Clinical Research /ID# 234651 - Miami
  • My Preferred Research LLC /ID# 237943 - Miami
  • South Miami Medical & Research Group Inc. /ID# 234654 - Miami
  • Valencia Medical & Research Center /ID# 234671 - Miami

California

  • Advanced Research Center /ID# 237960 - Anaheim
  • Kindred Medical Institute, LLC /ID# 237367 - Corona
  • Duplicate_Center for Clinical Trials LLC /ID# 234629 - Paramount
  • Medical Ctr for Clin Research /ID# 236911 - San Diego

Alabama

  • Central Research Associates /ID# 237953 - Birmingham
  • G & L Research, LLC /ID# 238093 - Foley
  • The Center for Clinical Trials Inc. /ID# 234605 - Saraland

Arkansas

  • HealthStar Research of Hot Springs PLLC /ID# 234608 - Hot Springs
  • Preferred Research Partners /ID# 237109 - Little Rock
  • Applied Research Center of Arkansas /ID# 238069 - Little Rock

Colorado

  • Lynn Institute of Denver /ID# 238086 - Aurora

District of Columbia

  • Childrens National Medical Center /ID# 234417 - Washington D.C.

Trial Details

FieldValue
Enrollment Target 381 participants
Start Date 2019-11-19
Est. Completion 2025-06-05
Phase Phase 3

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04166058

The ClinicalTrials.gov registry entry for NCT04166058 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 381 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 46-participant average among 4 other Functional Constipation trials with a reported enrollment target (728% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Functional Constipation appearing as the primary indexed condition, and to 2 interventions - of which Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers) is the first listed.

NCT04166058 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT04166058 about?

NCT04166058 is a clinical study titled "Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C". 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 ...

What is the current status of trial NCT04166058?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 381 participants. The study started on 2019-11-19. Estimated completion is 2025-06-05.

What conditions does trial NCT04166058 study?

This clinical trial studies the following conditions: Functional Constipation, Irritable Bowel Syndrome With Constipation.

What interventions are being tested in trial NCT04166058?

The interventions under investigation include: Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers) (DRUG), Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers) (DRUG).

Who is sponsoring clinical trial NCT04166058?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04166058 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.