Current partner codePEPTIDESDE
NCT04166058·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

381

Locations

72

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

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.

DRUG

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.

Timeline

From registration to results.

  1. First posted

    Nov 18, 2019

  2. Study start

    Nov 19, 2019

  3. Primary completion

    Jun 5, 2025

  4. Study completion

    Jun 5, 2025

  5. Results posted

    Jan 6, 2026

  6. Registry updated

    Jan 6, 2026

Outcomes

What the study measures.

Primary outcomes

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)].

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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
6 Years
Maximum age
18 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

72 registered sites.

Canada · Israel · Netherlands · United States. Showing up to 24 locations stored in the fast local snapshot.

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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Linaclotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.