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

Completed · Phase 3 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome With Constipation, Functional Constipation

In brief

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.

Key facts

Study ID: NCT04166058
Run by: AbbVie
People needed: 381
Starts: 2019-11-19
Expected to finish: 2025-06-05
Last updated by the study team: 2026-01-06

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant weighs ≥ 18 kg at the time the parent/guardian/LAR and/or caregiver has provided signed consent.
Female participants who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception.
Participants must have completed study intervention in their lead-in study.
Inclusion Criteria for Phase 2 LIN-MD-62 or Phase 2 LIN-MD-63 and Phase 3 LIN-MD-64 completers who enroll in LIN-MD-66 after >28 days from last study intervention:
Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit (Visit 1) and negative urine pregnancy test prior to the first dose on the Day 1 Visit (Visit 2).

You may not qualify if…

Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class.
Participant received an investigational drug, other than linaclotide, during the 30 days before the Screening Visit (Visit 1) or is planning to receive an investigational drug (other than that administered during this study) or use an investigational device at any time during the study.
Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
Participant has required manual disimpaction any time prior to study intervention or disimpaction during in-patient hospitalization within 1 year prior to study intervention.
Participant has any of the following conditions:
a) Down's syndrome or any other chromosomal disorder
b) Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus)
c) Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies)
d) Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma)
e) Neurodevelopmental disabilities (early-onset, chronic disorders that share the essential feature of a predominant disturbance in the acquisition of cognitive, motor, language, or social skills, which has a significant and continuing impact on the developmental progress of an individual) producing a cognitive delay that precludes comprehension by the participant.
Participant has a mechanical bowel obstruction or pseudo-obstruction.
Participant currently has both unexplained and clinically significant alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process.
Participant has an active anal fissure (Note: history of anal fissure is not an exclusion).
Participant has had surgery that meets any of the following criteria:
a) Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit (Visit 1).
b) Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit (Visit 1)
c) An appendectomy or cholecystectomy during the 60 days before the Screening Visit
d) Other major surgery during the 30 days before the Screening Visit (Visit 1)
Participant is receiving enteral tube feeding
Participants who have positive urine drug screen results for cocaine, barbiturates, opiates, or cannabinoids will be excluded from study participation.
Exclusion Criteria for LIN-MD-62, LIN-MD-63 and LIN-MD-64 Completers Who Enroll in LIN-MD-66 > 28 Days From Last Study Intervention:
Participant has a history of nonretentive fecal incontinence
Participant has a history of drug or alcohol abuse
Participant has any of the following conditions:
a) Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy

Where it is running

G & L Research, LLC /ID# 238093 — Foley, Alabama, United States
The Center for Clinical Trials Inc. /ID# 234605 — Saraland, Alabama, United States
HealthStar Research of Hot Springs PLLC /ID# 234608 — Hot Springs, Arkansas, United States
Preferred Research Partners /ID# 237109 — Little Rock, Arkansas, United States
Applied Research Center of Arkansas /ID# 238069 — Little Rock, Arkansas, United States
Advanced Research Center /ID# 237960 — Anaheim, California, United States
Kindred Medical Institute, LLC /ID# 237367 — Corona, California, United States
Duplicate_Center for Clinical Trials LLC /ID# 234629 — Paramount, California, United States
Medical Ctr for Clin Research /ID# 236911 — San Diego, California, United States
Lynn Institute of Denver /ID# 238086 — Aurora, Colorado, United States
Childrens National Medical Center /ID# 234417 — Washington D.C., District of Columbia, United States
Prohealth Research Center /ID# 234659 — Doral, Florida, United States
Dolphin Medical Research /ID# 234676 — Doral, Florida, United States
Amedica Research Institute Inc /ID# 234666 — Hialeah, Florida, United States
Nemours Childrens Specialty Care /ID# 237991 — Jacksonville, Florida, United States
Elite Clinical Research /ID# 234651 — Miami, Florida, United States
My Preferred Research LLC /ID# 237943 — Miami, Florida, United States
South Miami Medical & Research Group Inc. /ID# 234654 — Miami, Florida, United States
Valencia Medical & Research Center /ID# 234671 — Miami, Florida, United States
Advanced Research for Health Improvement /ID# 238253 — Naples, Florida, United States
Pediatric & Adult Research Center /ID# 234681 — Orlando, Florida, United States
Nemours Children's Hospital /ID# 234429 — Orlando, Florida, United States
Oviedo Medical Research /ID# 234692 — Oviedo, Florida, United States
Treken Primary Care /ID# 234645 — Atlanta, Georgia, United States
Central Research Associates /ID# 237953 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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