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NCT05652205

PHASE3

A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients, ages 2 to 5, who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. All participants in Part 2 will receive linaclotide. Approximately 116 participants aged 2 to 5 years with FC will be enrolled in this study at around 45 sites worldwide. Participants will receive daily doses of oral Linaclotide capsules or matching placebo for 12 weeks in Part 1 of the study. In Part 2, the open label long-term safety extension, participants with FC who completed study intervention in Part 1 of Study M21-572 or the Phase 2 Study LIN-MD-67 will receive linaclotide for 24 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation (FC) With a 24-week Open-label Treatment Extension

Key Details

Gender

All

Age Range

2 Years - 5 Years

Study Type

INTERVENTIONAL

Enrollment

123

Start Date

2022-12-29

Completion Date

2025-09-02

Last Updated

2026-05-14

Healthy Volunteers

Conditions

Functional Constipation (FC)Chronic Idiopathic Constipation (CIC)

Interventions

DRUG

Placebo for Linaclotide

Capsule; oral

DRUG

Linaclotide

Capsule; oral

Inclusion Criteria: * Caregiver/parent/guardian/legally authorized representative (LAR) is willing and able to comply with procedures required in this protocol, prior to the initiation of any screening or study-specific procedures. In addition, the caregiver/parent/guardian/LAR who will be completing the electronic diary (eDiary) must be able to read and understand the assessments in the eDiary device and undergo training. * Participant meets modified Rome IV criteria for FC: For at least 1 month before Screening (Visit 1), the participant has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) per week. In addition, at least once per week, participant must meet 1 or more of the following: * History of retentive posturing or excessive volitional stool retention. * History of painful or hard bowel movements (BMs). * Presence of a large fecal mass in the rectum. * History of large diameter stools. * At least 1 episode of fecal incontinence per week after the acquisition of toileting skills, if applicable. Exclusion Criteria: * Participant history of: * Celiac disease, or positive serological test for celiac disease or the condition is suspected but has not been ruled out by endoscopic biopsy * Cystic fibrosis * Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to Screening (Visit 1) * Down's syndrome or any other chromosomal disorder * Active anal fissure (i.e., participant reports having streaks of blood on the stool or on toilet paper and/or pain/crying with BM within 2 weeks prior to Screening). (Note: anal fissures that have resolved at least 2 weeks prior to screening would not be exclusionary.) However, if in the investigator's opinion, an anal fissure(s) may be the primary cause of participant's modified Rome IV FC criteria, the participant would not be eligible to participate in the study. * Anatomic malformations (e.g., imperforate anus, anal stenosis, anterior displaced anus) * Intestinal nerve or muscle disorders (e.g., Hirschprung disease, visceral myopathies, visceral neuropathies) * Neuropathic conditions (e.g., spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma) * Lead toxicity, hypercalcemia * Inflammatory bowel disease * Childhood functional abdominal pain syndrome * Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study * Lactose intolerance that is associated with symptoms which could confound the assessments in this study * History of cancer. (Note: participants with a history of cancer are allowed provided that the malignancy has been in a complete remission before Randomization (Visit 2). A complete remission is defined as the disappearance of all signs of cancer in response to treatment.) * Has conditions that could interfere with drug absorption including but not limited to short bowel syndrome.

Locations (48)

G & L Research, LLC /ID# 250658

Foley, Alabama, United States

Velocity Clinical Research - Phoenix /ID# 266280

Phoenix, Arizona, United States

HealthStar Research of Hot Springs PLLC /ID# 249481

Hot Springs, Arkansas, United States

Applied Research Center of Arkansas /ID# 249764

Little Rock, Arkansas, United States

Advanced Research Center /ID# 249412

Anaheim, California, United States

Kindred Medical Institute - Corona /ID# 249485

Corona, California, United States

Medical Ctr for Clin Research /ID# 254386

San Diego, California, United States

Prohealth Research Center /ID# 249420

Doral, Florida, United States

KIDZ Medical Services - Hollywood /ID# 250823

Hollywood, Florida, United States

Nemours Children's Health System /ID# 250881

Jacksonville, Florida, United States

Kissimmee Clinical Research /ID# 252206

Kissimmee, Florida, United States

South Miami Medical & Research Group Inc. /ID# 249418

Miami, Florida, United States

Valencia Medical & Research Center /ID# 250452

Miami, Florida, United States

Palmetto Professional Research /ID# 250875

Miami, Florida, United States

South Florida Research Ph I-IV /ID# 252350

Miami Springs, Florida, United States

Velocity Clinical Research Macon /ID# 266516

Macon, Georgia, United States

Rophe Adult & Pediatric Medicine /ID# 250663

Union City, Georgia, United States

Michael W. Simon, MD, PSC /ID# 250664

Lexington, Kentucky, United States

Velocity Clinical Research - Lafayette /ID# 266751

Lafayette, Louisiana, United States

Frederick County Pediatrics /ID# 249483

New Market, Maryland, United States

Michigan Center of Medical Research /ID# 251088

Farmington Hills, Michigan, United States

MNGI Digestive Health, P. A. /ID# 249676

Minneapolis, Minnesota, United States

Velocity Clinical Research- Hastings Nebraska /ID# 252132

Hastings, Nebraska, United States

Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 250876

Newark, New Jersey, United States

Univ NC Chapel Hill /ID# 252044

Chapel Hill, North Carolina, United States

UH Cleveland Medical Center /ID# 250893

Cleveland, Ohio, United States

IPS Research Company /ID# 250822

Oklahoma City, Oklahoma, United States

Frontier Clinical Research, LLC - Scottdale /ID# 250656

Scottdale, Pennsylvania, United States

Frontier Clinical Research - Smithfield /ID# 250657

Smithfield, Pennsylvania, United States

Coastal Pediatric Research - West Ashley B /ID# 249413

Charleston, South Carolina, United States

Tribe Clinical Research LLC /ID# 255656

Greenville, South Carolina, United States

Coastal Pediatric Research - Summerville /ID# 249423

Summerville, South Carolina, United States

Tullahoma Pediatrics /ID# 250892

Tullahoma, Tennessee, United States

Houston Clinical Research Associates /ID# 250779

Houston, Texas, United States

Prime Clinical Research - Mansfield - East Broad Street /ID# 266236

Mansfield, Texas, United States

ClinPoint Trials /ID# 250448

Waxahachie, Texas, United States

Carilion Medical Center /ID# 249790

Roanoke, Virginia, United States

Frontier Clinical Research - Kingwood /ID# 251154

Kingwood, West Virginia, United States

University Hospital Plovdiv /ID# 250814

Tsentar, Plovdiv, Bulgaria

UMHAT Kanev /ID# 250815

Rousse, Bulgaria

Acibadem City Clinic Tokuda University Hospital EAD /ID# 251234

Sofia, Bulgaria

Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 251233

Sofia, Bulgaria

Nova Clinic /ID# 250816

Varna, Bulgaria

Amphia Ziekenhuis /ID# 251698

Breda, North Brabant, Netherlands

Amsterdam UMC, locatie AMC /ID# 251295

Amsterdam, North Holland, Netherlands

Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 251179

London, Greater London, United Kingdom

Doncaster Royal Infirmary /ID# 252080

Armthorpe Road, United Kingdom

Northern Licolnshire and Goole NHS Foundation Trust /ID# 252007

Grimsby, United Kingdom

Clinical Research Directory

A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (48)