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CompletedPhase 3

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

Key facts

Who runs it
AbbVie
Where
Albuquerque, Anaheim, Atlanta, Aurora, Birmingham, Blue Ridge, Bridgeton, Charleston, Corona, Doral, East Orange, Flowood, Foley, Fort Worth, Franklin, Greenville, Harlingen, Hialeah, Hot Springs, Houston, Jackson, Jacksonville, Jefferson City, Lexington, Little Rock, Miami, Minneapolis, Naples, New York, Newport News, Oklahoma City, Orlando, Oviedo, Paramount, Plano, Port Gibson, Providence, Richmond, San Antonio, San Diego, Saraland, Scottdale, Silver Spring, Smithfield, St. George, Statesville, Stockbridge, Summerville, Tacoma, The Bronx, Washington D.C., Waxahachie, and Wichita, United StatesSee the 65 sitesAlso in 3 other countries, 7 sites
Status
Completed
Phase
Phase 3
People taking part
381 people enrolled
Started
19 Nov 2019
Ended
5 Jun 2025
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers)
  • Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
Record updated
6 January 2026

Who can take part

Age
6 years to 18 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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
  • 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)

Who cannot take part

  • 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
  • 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 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
  • Participants who have positive urine drug screen results for cocaine, barbiturates, opiates, or cannabinoids
  • Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class
  • 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 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 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; b) Cystic fibrosis; c) Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening (Visit 1); d) Lead toxicity, hypercalcemia; e) Inflammatory bowel disease; f) Childhood functional abdominal pain syndrome; g) Childhood functional abdominal pain; h) Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study; i) Lactose intolerance that is associated with abdominal pain or discomfort and could confound the assessments in this study; j) History of cancer other than treated basal cell carcinoma of the skin. (Note: Participants with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit. A complete remission is defined as the disappearance of all signs of cancer in response to treatment.); k) History of diabetic neuropathy
  • Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study
  • Participant has a mechanical bowel obstruction or pseudo-obstruction

Where in United States

Also in 3 other countries, 7 sites

  • University of New Mexico /ID# 236983Albuquerque, United StatesNo longer taking part
  • Advanced Research Center /ID# 237960Anaheim, United StatesNo longer taking part
  • Children's Ctr Digestive, US /ID# 237574Atlanta, United StatesNo longer taking part
  • Children's Healthcare of Atlanta - Ferry Rd /ID# 237005Atlanta, United StatesNo longer taking part
  • Treken Primary Care /ID# 234645Atlanta, United StatesNo longer taking part
  • Lynn Institute of Denver /ID# 238086Aurora, United StatesNo longer taking part
  • Central Research Associates /ID# 237953Birmingham, United StatesNo longer taking part
  • River Birch Research Alliance /ID# 237963Blue Ridge, United StatesNo longer taking part
  • Private Practice - Dr. Craig Spiegel /ID# 234545Bridgeton, United StatesNo longer taking part
  • Coastal Pediatric Research - West Ashley B /ID# 234678Charleston, United StatesNo longer taking part
  • Kindred Medical Institute, LLC /ID# 237367Corona, United StatesNo longer taking part
  • Dolphin Medical Research /ID# 234676Doral, United StatesNo longer taking part
  • Prohealth Research Center /ID# 234659Doral, United StatesNo longer taking part
  • Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 234566East Orange, United StatesNo longer taking part
  • GI associates and Endoscopy Ce /ID# 237969Flowood, United StatesNo longer taking part
  • G & L Research, LLC /ID# 238093Foley, United StatesNo longer taking part
  • Cook Children's Med. Center /ID# 237536Fort Worth, United StatesNo longer taking part
  • Office of Maria Ona /ID# 234539Franklin, United StatesNo longer taking part
  • East Carolina University - Brody School of Medicine /ID# 237509Greenville, United StatesNo longer taking part
  • Valley Institute of Research /ID# 234475Harlingen, United StatesNo longer taking part
  • Amedica Research Institute Inc /ID# 234666Hialeah, United StatesNo longer taking part
  • HealthStar Research of Hot Springs PLLC /ID# 234608Hot Springs, United StatesNo longer taking part
  • Cullen Research /ID# 234482Houston, United StatesNo longer taking part
  • Pioneer Research Solutions - Houston /ID# 236935Houston, United StatesNo longer taking part
  • Vilo Research Group Inc /ID# 238228Houston, United StatesNo longer taking part
  • The Jackson Clinic, PA /ID# 236772Jackson, United StatesNo longer taking part
  • Nemours Childrens Specialty Care /ID# 237991Jacksonville, United StatesNo longer taking part
  • Accellacare of Knoxville /ID# 234462Jefferson City, United StatesNo longer taking part
  • Michael W. Simon, MD, PSC /ID# 236516Lexington, United StatesNo longer taking part
  • Applied Research Center of Arkansas /ID# 238069Little Rock, United StatesNo longer taking part
  • Preferred Research Partners /ID# 237109Little Rock, United StatesNo longer taking part
  • Elite Clinical Research /ID# 234651Miami, United StatesNo longer taking part
  • My Preferred Research LLC /ID# 237943Miami, United StatesNo longer taking part
  • South Miami Medical & Research Group Inc. /ID# 234654Miami, United StatesNo longer taking part
  • Valencia Medical & Research Center /ID# 234671Miami, United StatesNo longer taking part
  • MNGI Digestive Health, P. A. /ID# 234437Minneapolis, United StatesNo longer taking part
  • Advanced Research for Health Improvement /ID# 238253Naples, United StatesNo longer taking part
  • Columbia University Irving Medical Center /ID# 235686New York, United StatesNo longer taking part
  • Health Research of Hampton Roads, Inc. (HRHR) /ID# 237252Newport News, United StatesNo longer taking part
  • IPS Research Company /ID# 237669Oklahoma City, United StatesNo longer taking part
  • Univ Oklahoma HSC /ID# 237546Oklahoma City, United StatesNo longer taking part
  • Nemours Children's Hospital /ID# 234429Orlando, United StatesNo longer taking part
  • Pediatric & Adult Research Center /ID# 234681Orlando, United StatesNo longer taking part
  • Oviedo Medical Research /ID# 234692Oviedo, United StatesNo longer taking part
  • Duplicate_Center for Clinical Trials LLC /ID# 234629Paramount, United StatesNo longer taking part
  • AIM Trials /ID# 236364Plano, United StatesNo longer taking part
  • David M. Headley, MD, P.A. /ID# 238216Port Gibson, United StatesNo longer taking part
  • Rhode Island Hospital /ID# 237861Providence, United StatesNo longer taking part
  • Clinical Research Partners, LLC /ID# 237158Richmond, United StatesNo longer taking part
  • Sun Research Institute /ID# 236932San Antonio, United StatesNo longer taking part
  • Medical Ctr for Clin Research /ID# 236911San Diego, United StatesNo longer taking part
  • The Center for Clinical Trials Inc. /ID# 234605Saraland, United StatesNo longer taking part
  • Frontier Clinical Research, LLC - Scottdale /ID# 238022Scottdale, United StatesNo longer taking part
  • Virgo Carter Pediatrics /ID# 234518Silver Spring, United StatesNo longer taking part
  • Duplicate_Frontier Clinical Research /ID# 237923Smithfield, United StatesNo longer taking part
  • Duplicate_Chrysalis Clinical Research /ID# 234515St. George, United StatesNo longer taking part
  • PMG Research of Piedmont Healthcare-Statesville /ID# 238257Statesville, United StatesNo longer taking part
  • Clinical Research Institute /ID# 234702Stockbridge, United StatesNo longer taking part
  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236342Stockbridge, United StatesNo longer taking part
  • Coastal Pediatric Research - Summerville /ID# 234674Summerville, United StatesNo longer taking part
  • Duplicate_Multicare Institute for Research and Innovation /ID# 236979Tacoma, United StatesNo longer taking part
  • Advantage Clinical Trials /ID# 237932The Bronx, United StatesNo longer taking part
  • Childrens National Medical Center /ID# 234417Washington D.C., United StatesNo longer taking part
  • ClinPoint Trials /ID# 236615Waxahachie, United StatesNo longer taking part
  • KU Wichita Center for Clinical Research /ID# 234500Wichita, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • 72 μg linaclotideExisting treatment, for comparison

    An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

    Treatment: Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)

  • 145 μg linaclotideExisting treatment, for comparison

    An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

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

  • 290 μg linaclotideExisting treatment, for comparison

    An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

    Treatment: Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers)

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 3, Open-label, Long-term Safety Study of Oral Linaclotide Administered to Pediatric Participants With Functional Constipation (FC) or Irritable Bowel Syndrome With Constipation (IBS-C)
Record updated
6 January 2026