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

Completed · Phase 3 · Has a placebo group

Conditions studied: Functional Constipation (FC), Chronic Idiopathic Constipation (CIC)

In brief

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.

Key facts

Study ID

NCT05652205

Run by

AbbVie

People needed

123

Starts

2022-12-29

Expected to finish

2025-09-02

Last updated by the study team

2026-05-14

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.