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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT04166058 (opens ClinicalTrials.gov in a new tab)Other idLIN-MD-66Other id2019-001955-38Other id2019

Overview

Status
Completed
Phase
Phase 3
Enrollment
381 participants (actual)
Sponsor
AbbVie · Industry
Design
Not randomized · Open label (no masking)
Countries
4 countries

United States, Canada, Israel, Netherlands

Start
19 Nov 2019
Primary completion
5 Jun 2025
Completion
5 Jun 2025
First posted
18 Nov 2019
Last update posted
6 Jan 2026
Conditions
Irritable Bowel Syndrome With Constipation · Functional Constipation

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202220242026
  1. Ph 3

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

    NCT04166058

    19 Nov 2019 to 5 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • 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)Drug

Arms3

  • Active comparator

    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.

  • Active comparator

    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.

  • Active comparator

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs).

    Time frame · 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)].

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 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)].

Number of Participants With Treatment-Emergent Adverse Events (TEAEs).

GroupValue (Participants)
FC 72 ug Linaclotide37
FC 145 ug Linaclotide15
IBS-C 145 ug Linaclotide4
IBS-C 290 ug Linaclotide31

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
FC 72 ug LinaclotideFunctional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study: Participants aged 6 to 11 years received an open-label dose of linaclotide 72 ug, oral capsule, once daily for 24 weeks. Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.0 / 2102 / 21014 / 210
FC 145 ug LinaclotideFunctional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study: Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks.0 / 730 / 735 / 73
IBS-C 145 ug LinaclotideIrritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows: Participants who received ≤ 145 ug linaclotide or placebo in lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 145 ug, oral capsule, once daily for 52 weeks. Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.0 / 220 / 220 / 22
IBS-C 290 ug LinaclotideIrritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows: Participants who completed lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks. Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks.0 / 762 / 7611 / 76

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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