Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
NCT ID: NCT04166058
Last Updated: 2026-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
381 participants
INTERVENTIONAL
2019-11-19
2025-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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72 μg linaclotide
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.
Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
Participants whom are between the ages of 6-11 years old at their time of enrollment will be assigned a dose of 72 μg.
Participants whom are between the ages of 12-17 years old at their time of enrollment will be randomized at 1:1 ratio to 72 or 145 μg linaclotide.
145 μg linaclotide
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.
Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers)
Participants who completed study LIN-MD-63 at their time of enrollment will be assigned a dose of 290 μg. Participants who received ≤ 145 μg linaclotide or placebo in study LIN-MD-63 at the time of completion will continue to receive 145 μg.
Participants who completed study LIN-MD-64 at their time of enrollment will be assigned a dose of 290 μg if they choose to receive open-label or continue to receive blinded dose of 145 or 290 μg if they choose to remain on the same blinded dose.
Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
Participants whom are between the ages of 6-11 years old at their time of enrollment will be assigned a dose of 72 μg.
Participants whom are between the ages of 12-17 years old at their time of enrollment will be randomized at 1:1 ratio to 72 or 145 μg linaclotide.
290 μg linaclotide
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.
Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers)
Participants who completed study LIN-MD-63 at their time of enrollment will be assigned a dose of 290 μg. Participants who received ≤ 145 μg linaclotide or placebo in study LIN-MD-63 at the time of completion will continue to receive 145 μg.
Participants who completed study LIN-MD-64 at their time of enrollment will be assigned a dose of 290 μg if they choose to receive open-label or continue to receive blinded dose of 145 or 290 μg if they choose to remain on the same blinded dose.
Interventions
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Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers)
Participants who completed study LIN-MD-63 at their time of enrollment will be assigned a dose of 290 μg. Participants who received ≤ 145 μg linaclotide or placebo in study LIN-MD-63 at the time of completion will continue to receive 145 μg.
Participants who completed study LIN-MD-64 at their time of enrollment will be assigned a dose of 290 μg if they choose to receive open-label or continue to receive blinded dose of 145 or 290 μg if they choose to remain on the same blinded dose.
Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
Participants whom are between the ages of 6-11 years old at their time of enrollment will be assigned a dose of 72 μg.
Participants whom are between the ages of 12-17 years old at their time of enrollment will be randomized at 1:1 ratio to 72 or 145 μg linaclotide.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
* 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.
6 Years
18 Years
ALL
No
Sponsors
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Ironwood Pharmaceuticals, Inc.
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Central Research Associates /ID# 237953
Birmingham, Alabama, United States
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
Children's Healthcare of Atlanta - Ferry Rd /ID# 237005
Atlanta, Georgia, United States
Children's Ctr Digestive, US /ID# 237574
Atlanta, Georgia, United States
River Birch Research Alliance /ID# 237963
Blue Ridge, Georgia, United States
Clinical Research Institute /ID# 234702
Stockbridge, Georgia, United States
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236342
Stockbridge, Georgia, United States
KU Wichita Center for Clinical Research /ID# 234500
Wichita, Kansas, United States
Michael W. Simon, MD, PSC /ID# 236516
Lexington, Kentucky, United States
Virgo Carter Pediatrics /ID# 234518
Silver Spring, Maryland, United States
MNGI Digestive Health, P. A. /ID# 234437
Minneapolis, Minnesota, United States
GI associates and Endoscopy Ce /ID# 237969
Flowood, Mississippi, United States
David M. Headley, MD, P.A. /ID# 238216
Port Gibson, Mississippi, United States
Private Practice - Dr. Craig Spiegel /ID# 234545
Bridgeton, Missouri, United States
Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 234566
East Orange, New Jersey, United States
University of New Mexico /ID# 236983
Albuquerque, New Mexico, United States
Columbia University Irving Medical Center /ID# 235686
New York, New York, United States
Advantage Clinical Trials /ID# 237932
The Bronx, New York, United States
East Carolina University - Brody School of Medicine /ID# 237509
Greenville, North Carolina, United States
PMG Research of Piedmont Healthcare-Statesville /ID# 238257
Statesville, North Carolina, United States
Univ Oklahoma HSC /ID# 237546
Oklahoma City, Oklahoma, United States
IPS Research Company /ID# 237669
Oklahoma City, Oklahoma, United States
Frontier Clinical Research, LLC - Scottdale /ID# 238022
Scottdale, Pennsylvania, United States
Duplicate_Frontier Clinical Research /ID# 237923
Smithfield, Pennsylvania, United States
Rhode Island Hospital /ID# 237861
Providence, Rhode Island, United States
Coastal Pediatric Research - West Ashley B /ID# 234678
Charleston, South Carolina, United States
Coastal Pediatric Research - Summerville /ID# 234674
Summerville, South Carolina, United States
The Jackson Clinic, PA /ID# 236772
Jackson, Tennessee, United States
Accellacare of Knoxville /ID# 234462
Jefferson City, Tennessee, United States
Cook Children's Med. Center /ID# 237536
Fort Worth, Texas, United States
Valley Institute of Research /ID# 234475
Harlingen, Texas, United States
Vilo Research Group Inc /ID# 238228
Houston, Texas, United States
Cullen Research /ID# 234482
Houston, Texas, United States
Pioneer Research Solutions - Houston /ID# 236935
Houston, Texas, United States
AIM Trials /ID# 236364
Plano, Texas, United States
Sun Research Institute /ID# 236932
San Antonio, Texas, United States
ClinPoint Trials /ID# 236615
Waxahachie, Texas, United States
Duplicate_Chrysalis Clinical Research /ID# 234515
St. George, Utah, United States
Office of Maria Ona /ID# 234539
Franklin, Virginia, United States
Health Research of Hampton Roads, Inc. (HRHR) /ID# 237252
Newport News, Virginia, United States
Clinical Research Partners, LLC /ID# 237158
Richmond, Virginia, United States
Duplicate_Multicare Institute for Research and Innovation /ID# 236979
Tacoma, Washington, United States
London Health Sciences Center- University Hospital /ID# 234309
London, Ontario, Canada
Bluewater Clinical Research Group Inc /ID# 234618
Sarnia, Ontario, Canada
Stouffville Medical Centre /ID# 234619
Stouffville, Ontario, Canada
Hadassah Hebrew University Hospital - Ein Kerem /ID# 234735
Jerusalem, Jerusalem, Israel
The Baruch Padeh Medical Center Poriya /ID# 234768
Tiberias, Northern District, Israel
The Chaim Sheba Medical Center /ID# 236760
Ramat Gan, Tel Aviv, Israel
Duplicate_Academisch Medisch Centrum /ID# 237116
Amsterdam, North Holland, Netherlands
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-001955-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LIN-MD-66
Identifier Type: -
Identifier Source: org_study_id
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