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Constipation drug linaclotide tested for Long-Term safety in kids

NCT ID NCT04166058

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of the drug linaclotide in children aged 6 to 17 with functional constipation or irritable bowel syndrome with constipation (IBS-C). A total of 381 children who had already completed earlier studies took linaclotide for 24 or 52 weeks. The main goal was to track any side effects, not to measure how well the drug worked.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
linaclotide (oral capsule)
What this could lead to
If successful, this could confirm that linaclotide is safe for long-term use in children with chronic constipation or IBS-C, offering a reliable treatment option.
What could go wrong
This is a safety study, not designed to prove how well the drug works. Side effects are possible, and results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

381 people

The number who actually took part.

Started

Nov 2019

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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 * 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 * Participants who have positive urine drug screen results for cocaine, barbiturates, opiates, or cannabinoids.

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Conditions

The condition(s) this trial relates to.

constipation disorder irritable bowel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Functional constipation Irritable bowel syndrome with constipation

Contacts and locations

Locations

  • AIM Trials /ID# 236364

    Plano, Texas, 75093, United States

  • Accellacare of Knoxville /ID# 234462

    Jefferson City, Tennessee, 37760, United States

  • Advanced Research Center /ID# 237960

    Anaheim, California, 92805, United States

  • Advanced Research for Health Improvement /ID# 238253

    Naples, Florida, 34102-5430, United States

  • Advantage Clinical Trials /ID# 237932

    The Bronx, New York, 10468, United States

  • Amedica Research Institute Inc /ID# 234666

    Hialeah, Florida, 33013, United States

  • Applied Research Center of Arkansas /ID# 238069

    Little Rock, Arkansas, 72212-4187, United States

  • Bluewater Clinical Research Group Inc /ID# 234618

    Sarnia, Ontario, N7T 4X3, Canada

  • Central Research Associates /ID# 237953

    Birmingham, Alabama, 35205, United States

  • Children's Ctr Digestive, US /ID# 237574

    Atlanta, Georgia, 30342, United States

  • Children's Healthcare of Atlanta - Ferry Rd /ID# 237005

    Atlanta, Georgia, 30342-1605, United States

  • Childrens National Medical Center /ID# 234417

    Washington D.C., District of Columbia, 20010-2916, United States

  • ClinPoint Trials /ID# 236615

    Waxahachie, Texas, 75165-1430, United States

  • Clinical Research Institute /ID# 234702

    Stockbridge, Georgia, 30281, United States

  • Clinical Research Partners, LLC /ID# 237158

    Richmond, Virginia, 23220-4459, United States

  • Coastal Pediatric Research - Summerville /ID# 234674

    Summerville, South Carolina, 29486, United States

  • Coastal Pediatric Research - West Ashley B /ID# 234678

    Charleston, South Carolina, 29414, United States

  • Columbia University Irving Medical Center /ID# 235686

    New York, New York, 10032, United States

  • Cook Children's Med. Center /ID# 237536

    Fort Worth, Texas, 76104, United States

  • Cullen Research /ID# 234482

    Houston, Texas, 77051, United States

  • David M. Headley, MD, P.A. /ID# 238216

    Port Gibson, Mississippi, 39150-2024, United States

  • Dolphin Medical Research /ID# 234676

    Doral, Florida, 33172, United States

  • Duplicate_Academisch Medisch Centrum /ID# 237116

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Duplicate_Center for Clinical Trials LLC /ID# 234629

    Paramount, California, 90723, United States

  • Duplicate_Chrysalis Clinical Research /ID# 234515

    St. George, Utah, 84790, United States

  • Duplicate_Frontier Clinical Research /ID# 237923

    Smithfield, Pennsylvania, 15478, United States

  • Duplicate_Multicare Institute for Research and Innovation /ID# 236979

    Tacoma, Washington, 98405, United States

  • East Carolina University - Brody School of Medicine /ID# 237509

    Greenville, North Carolina, 27834, United States

  • Elite Clinical Research /ID# 234651

    Miami, Florida, 33144, United States

  • Frontier Clinical Research, LLC - Scottdale /ID# 238022

    Scottdale, Pennsylvania, 15683, United States

  • G & L Research, LLC /ID# 238093

    Foley, Alabama, 36535, United States

  • GI associates and Endoscopy Ce /ID# 237969

    Flowood, Mississippi, 39232, United States

  • Hadassah Hebrew University Hospital - Ein Kerem /ID# 234735

    Jerusalem, Jerusalem, 91120, Israel

  • Health Research of Hampton Roads, Inc. (HRHR) /ID# 237252

    Newport News, Virginia, 23606, United States

  • HealthStar Research of Hot Springs PLLC /ID# 234608

    Hot Springs, Arkansas, 71913, United States

  • IPS Research Company /ID# 237669

    Oklahoma City, Oklahoma, 73106, United States

  • KU Wichita Center for Clinical Research /ID# 234500

    Wichita, Kansas, 67214, United States

  • Kindred Medical Institute, LLC /ID# 237367

    Corona, California, 92879, United States

  • London Health Sciences Center- University Hospital /ID# 234309

    London, Ontario, N6A 5W9, Canada

  • Lynn Institute of Denver /ID# 238086

    Aurora, Colorado, 80012, United States

  • MNGI Digestive Health, P. A. /ID# 234437

    Minneapolis, Minnesota, 55413-2195, United States

  • Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 234566

    East Orange, New Jersey, 07018, United States

  • Medical Ctr for Clin Research /ID# 236911

    San Diego, California, 92108, United States

  • Michael W. Simon, MD, PSC /ID# 236516

    Lexington, Kentucky, 40517, United States

  • My Preferred Research LLC /ID# 237943

    Miami, Florida, 33155, United States

  • Nemours Children's Hospital /ID# 234429

    Orlando, Florida, 32827-7884, United States

  • Nemours Childrens Specialty Care /ID# 237991

    Jacksonville, Florida, 32207, United States

  • Office of Maria Ona /ID# 234539

    Franklin, Virginia, 23851, United States

  • Oviedo Medical Research /ID# 234692

    Oviedo, Florida, 32765, United States

  • PMG Research of Piedmont Healthcare-Statesville /ID# 238257

    Statesville, North Carolina, 28625, United States

  • Pediatric & Adult Research Center /ID# 234681

    Orlando, Florida, 32825, United States

  • Pioneer Research Solutions - Houston /ID# 236935

    Houston, Texas, 77099-4307, United States

  • Preferred Research Partners /ID# 237109

    Little Rock, Arkansas, 72211, United States

  • Private Practice - Dr. Craig Spiegel /ID# 234545

    Bridgeton, Missouri, 63044, United States

  • Prohealth Research Center /ID# 234659

    Doral, Florida, 33166, United States

  • Rhode Island Hospital /ID# 237861

    Providence, Rhode Island, 02903, United States

  • River Birch Research Alliance /ID# 237963

    Blue Ridge, Georgia, 30513, United States

  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236342

    Stockbridge, Georgia, 30281, United States

  • South Miami Medical & Research Group Inc. /ID# 234654

    Miami, Florida, 33155, United States

  • Stouffville Medical Centre /ID# 234619

    Stouffville, Ontario, L4A 1H2, Canada

  • Sun Research Institute /ID# 236932

    San Antonio, Texas, 78215, United States

  • The Baruch Padeh Medical Center Poriya /ID# 234768

    Tiberias, Northern District, 15208, Israel

  • The Center for Clinical Trials Inc. /ID# 234605

    Saraland, Alabama, 36571, United States

  • The Chaim Sheba Medical Center /ID# 236760

    Ramat Gan, Tel Aviv, 5265601, Israel

  • The Jackson Clinic, PA /ID# 236772

    Jackson, Tennessee, 38305, United States

  • Treken Primary Care /ID# 234645

    Atlanta, Georgia, 30315, United States

  • Univ Oklahoma HSC /ID# 237546

    Oklahoma City, Oklahoma, 73104, United States

  • University of New Mexico /ID# 236983

    Albuquerque, New Mexico, 87102-4517, United States

  • Valencia Medical & Research Center /ID# 234671

    Miami, Florida, 33165, United States

  • Valley Institute of Research /ID# 234475

    Harlingen, Texas, 78550, United States

  • Vilo Research Group Inc /ID# 238228

    Houston, Texas, 77017-2337, United States

  • Virgo Carter Pediatrics /ID# 234518

    Silver Spring, Maryland, 20910, United States

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