Irritable Bowel Syndrome With ConstipationPhase 3NCT04166058
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
A Phase 3 study testing 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) in people with Irritable Bowel Syndrome With Constipation and Functional Constipation, run by AbbVie at 72 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Irritable Bowel Syndrome With Constipation, Functional Constipation
- What is being tested?
- 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)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 72 sitesin 4 countries
- Study dates
- 19 Nov 2019to 5 Jun 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
72 sites in 4 countries.
72 sites in 4 countries
United States65 sites
University of New Mexico /ID# 236983
Albuquerque, New Mexico, 87102-4517
Advanced Research Center /ID# 237960
Anaheim, California, 92805
Treken Primary Care /ID# 234645
Atlanta, Georgia, 30315
Children's Healthcare of Atlanta - Ferry Rd /ID# 237005
Atlanta, Georgia, 30342-1605
Children's Ctr Digestive, US /ID# 237574
Atlanta, Georgia, 30342
Lynn Institute of Denver /ID# 238086
Aurora, Colorado, 80012
Central Research Associates /ID# 237953
Birmingham, Alabama, 35205
River Birch Research Alliance /ID# 237963
Blue Ridge, Georgia, 30513
Private Practice - Dr. Craig Spiegel /ID# 234545
Bridgeton, Missouri, 63044
Coastal Pediatric Research - West Ashley B /ID# 234678
Charleston, South Carolina, 29414
Kindred Medical Institute, LLC /ID# 237367
Corona, California, 92879
Prohealth Research Center /ID# 234659
Doral, Florida, 33166
Dolphin Medical Research /ID# 234676
Doral, Florida, 33172
Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 234566
East Orange, New Jersey, 07018
GI associates and Endoscopy Ce /ID# 237969
Flowood, Mississippi, 39232
G & L Research, LLC /ID# 238093
Foley, Alabama, 36535
Cook Children's Med. Center /ID# 237536
Fort Worth, Texas, 76104
Office of Maria Ona /ID# 234539
Franklin, Virginia, 23851
East Carolina University - Brody School of Medicine /ID# 237509
Greenville, North Carolina, 27834
Valley Institute of Research /ID# 234475
Harlingen, Texas, 78550
Amedica Research Institute Inc /ID# 234666
Hialeah, Florida, 33013
HealthStar Research of Hot Springs PLLC /ID# 234608
Hot Springs, Arkansas, 71913
Vilo Research Group Inc /ID# 238228
Houston, Texas, 77017-2337
Cullen Research /ID# 234482
Houston, Texas, 77051
Pioneer Research Solutions - Houston /ID# 236935
Houston, Texas, 77099-4307
The Jackson Clinic, PA /ID# 236772
Jackson, Tennessee, 38305
Nemours Childrens Specialty Care /ID# 237991
Jacksonville, Florida, 32207
Accellacare of Knoxville /ID# 234462
Jefferson City, Tennessee, 37760
Michael W. Simon, MD, PSC /ID# 236516
Lexington, Kentucky, 40517
Preferred Research Partners /ID# 237109
Little Rock, Arkansas, 72211
Applied Research Center of Arkansas /ID# 238069
Little Rock, Arkansas, 72212-4187
Elite Clinical Research /ID# 234651
Miami, Florida, 33144
My Preferred Research LLC /ID# 237943
Miami, Florida, 33155
South Miami Medical & Research Group Inc. /ID# 234654
Miami, Florida, 33155
Valencia Medical & Research Center /ID# 234671
Miami, Florida, 33165
MNGI Digestive Health, P. A. /ID# 234437
Minneapolis, Minnesota, 55413-2195
Advanced Research for Health Improvement /ID# 238253
Naples, Florida, 34102-5430
Columbia University Irving Medical Center /ID# 235686
New York, New York, 10032
Health Research of Hampton Roads, Inc. (HRHR) /ID# 237252
Newport News, Virginia, 23606
Univ Oklahoma HSC /ID# 237546
Oklahoma City, Oklahoma, 73104
IPS Research Company /ID# 237669
Oklahoma City, Oklahoma, 73106
Pediatric & Adult Research Center /ID# 234681
Orlando, Florida, 32825
Nemours Children's Hospital /ID# 234429
Orlando, Florida, 32827-7884
Oviedo Medical Research /ID# 234692
Oviedo, Florida, 32765
Duplicate_Center for Clinical Trials LLC /ID# 234629
Paramount, California, 90723
AIM Trials /ID# 236364
Plano, Texas, 75093
David M. Headley, MD, P.A. /ID# 238216
Port Gibson, Mississippi, 39150-2024
Rhode Island Hospital /ID# 237861
Providence, Rhode Island, 02903
Clinical Research Partners, LLC /ID# 237158
Richmond, Virginia, 23220-4459
Sun Research Institute /ID# 236932
San Antonio, Texas, 78215
Medical Ctr for Clin Research /ID# 236911
San Diego, California, 92108
The Center for Clinical Trials Inc. /ID# 234605
Saraland, Alabama, 36571
Frontier Clinical Research, LLC - Scottdale /ID# 238022
Scottdale, Pennsylvania, 15683
Virgo Carter Pediatrics /ID# 234518
Silver Spring, Maryland, 20910
Duplicate_Frontier Clinical Research /ID# 237923
Smithfield, Pennsylvania, 15478
Duplicate_Chrysalis Clinical Research /ID# 234515
St. George, Utah, 84790
PMG Research of Piedmont Healthcare-Statesville /ID# 238257
Statesville, North Carolina, 28625
Clinical Research Institute /ID# 234702
Stockbridge, Georgia, 30281
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236342
Stockbridge, Georgia, 30281
Coastal Pediatric Research - Summerville /ID# 234674
Summerville, South Carolina, 29486
Duplicate_Multicare Institute for Research and Innovation /ID# 236979
Tacoma, Washington, 98405
Advantage Clinical Trials /ID# 237932
The Bronx, New York, 10468
Childrens National Medical Center /ID# 234417
Washington D.C., District of Columbia, 20010-2916
ClinPoint Trials /ID# 236615
Waxahachie, Texas, 75165-1430
KU Wichita Center for Clinical Research /ID# 234500
Wichita, Kansas, 67214
Canada3 sites
London Health Sciences Center- University Hospital /ID# 234309
London, Ontario, N6A 5W9
Bluewater Clinical Research Group Inc /ID# 234618
Sarnia, Ontario, N7T 4X3
Stouffville Medical Centre /ID# 234619
Stouffville, Ontario, L4A 1H2
Israel3 sites
Hadassah Hebrew University Hospital - Ein Kerem /ID# 234735
Jerusalem, Jerusalem, 91120
The Chaim Sheba Medical Center /ID# 236760
Ramat Gan, Tel Aviv, 5265601
The Baruch Padeh Medical Center Poriya /ID# 234768
Tiberias, Northern District, 15208
Netherlands1 site
Duplicate_Academisch Medisch Centrum /ID# 237116
Amsterdam, North Holland, 1105 AZ
About this study
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)
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.
- Being 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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers)Drug
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)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 72 μg linaclotide | Active comparator | 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. Receives: Drug: Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers) |
| 145 μg linaclotide | Active comparator | 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. Receives: 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) |
| 290 μg linaclotide | Active comparator | 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. Receives: Drug: Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs).
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 disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Measured: From first dose of study drug until 30 days following last dose of study drug [up to 24 weeks (FC participants) or 52 weeks (IBS-C participants)].
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start19 Nov 2019
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritable Bowel Syndrome With ConstipationStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ironwood Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166058
- Sponsor's protocol ID
- LIN-MD-66
- Other IDs
- 2019-001955-38, 2019
- Status last verified
- Nov 2025
- First submitted
- 11 Nov 2019
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.