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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: Completed Phase 3 study of Functional Constipation and Irritable Bowel Syndrome With Constipation, sponsored by AbbVie.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant di
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 381 participants |
| Start Date | 2019-11-19 |
| Est. Completion | 2025-06-05 |
| Phase | Phase 3 |
What the finished NCT04166058 record still lists
NCT04166058 is an interventional study that assigns participants to a tested intervention. The registered 381 participants enrollment target is mid-sized for trials with a published cap, above the 46-participant average among 4 other Functional Constipation trials with a reported enrollment target (728% higher).
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 names 20 study sites across 6 states, led by 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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