A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide

NCT ID: NCT05760313

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-27
• Study Completion Date: 2025-06-09

Brief 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 who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 3 groups, which occur consecutively. Each group receives a different dosage of linaclotide. In Part 2 of the study, participants will be randomly assigned to receive either linaclotide or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Up to 30 and at least 18 pediatric participants 6 months to less than 2 years of age with FC will be enrolled in the study at approximately 38 sites worldwide.

Participants will receive oral solution of linaclotide prepared from capsule by parent/guardian once daily for 4 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 regular 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.

Conditions

Functional Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part 2, Linaclotide

Participants will receive Linaclotide capsules mixed with water and administered orally in Part 2 for 4 weeks.

Group Type: EXPERIMENTAL

Linaclotide

Intervention Type: DRUG

Capsule; oral

Part 2, Placebo

Participants will receive placebo capsules mixed with water and administered orally in Part 2 for 4 weeks.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Capsule; oral

Part 1, Linaclotide Dose A

Linaclotide Dose A capsules, mixed with water and administered orally, once daily for 4 weeks

Group Type: EXPERIMENTAL

Linaclotide

Intervention Type: DRUG

Capsule; oral

Part 1, Linaclotide Dose B

Linaclotide Dose B capsules, mixed with water and administered orally, once daily for 4 weeks

Group Type: EXPERIMENTAL

Linaclotide

Intervention Type: DRUG

Capsule; oral

Part 1, Linaclotide Dose C

Linaclotide Dose C capsules, mixed with water and administered orally, once daily for 4 weeks

Group Type: EXPERIMENTAL

Linaclotide

Intervention Type: DRUG

Capsule; oral

Interventions

Linaclotide

Capsule; oral

Intervention Type: DRUG

Placebo

Capsule; oral

Intervention Type: DRUG

Other Intervention Names

Linzess

Eligibility Criteria

Inclusion Criteria

• Individuals must be 6 months to less than 1 year and 11 months old, at the time the legally authorized representative (LAR)/parent/guardian signs the informed consent in alignment with local requirements.
• The LAR/parent/guardian who will be completing the electronic diary (eDiary) is able to read and understand the assessments in the eDiary device and must undergo training.
• Participant meets Rome IV criteria for functional constipation (FC): for at least 1 month before Screening (Visit 1), the participant must meet 2 or more of the following:

• 2 or fewer defecations per week (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours)
• History of excessive stool retention
• History of painful or hard bowel movements (BMs)
• History of large-diameter stools
• Presence of a large fecal mass in the rectum
• LAR/Parent/Guardian is willing to discontinue any laxatives used before the Preintervention Visit in favor of the protocol-permitted rescue medicine.

Exclusion Criteria

• Participant has conditions that could interfere with drug absorption, including, but not limited to, short bowel syndrome.
• History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the individual's participation in this study or would make the participant an unsuitable candidate to receive study drug.
• Participant has 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 (investigator has confirmed an active anal fissure and participant reports known anal fissure symptoms [i.e., streaks of blood on the stool or on diaper or toilet paper and pain/crying with bowel movement 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 Rome IV FC criteria, the subject 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
• 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 enrollment/randomization (Visit 3). A complete remission is defined as the disappearance of all signs of cancer in response to treatment)

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ironwood Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Velocity Clinical Research - Phoenix /ID# 263871

Phoenix, Arizona, United States

HealthStar Research of Hot Springs PLLC /ID# 251553

Hot Springs, Arkansas, United States

Advanced Research Center /ID# 248763

Anaheim, California, United States

Kindred Medical Institute - Corona /ID# 251535

Corona, California, United States

Velocity Clinical Research Washington DC /ID# 263872

Washington D.C., District of Columbia, United States

Prohealth Research Center /ID# 248696

Doral, Florida, United States

South Miami Medical & Research Group Inc. /ID# 248765

Miami, Florida, United States

Valencia Medical & Research Center /ID# 251533

Miami, Florida, United States

Velocity Clinical Research Macon /ID# 263959

Macon, Georgia, United States

Velocity Clinical Research - Lafayette /ID# 263873

Lafayette, Louisiana, United States

Frederick County Pediatrics /ID# 251555

New Market, Maryland, United States

Michigan Center of Medical Research /ID# 253536

Farmington Hills, Michigan, United States

Velocity Clinical Research- Hastings Nebraska /ID# 260932

Hastings, Nebraska, United States

Coastal Pediatric Research - West Ashley B /ID# 248693

Charleston, South Carolina, United States

Coastal Pediatric Research - Summerville /ID# 253534

Summerville, South Carolina, United States

Houston Clinical Research Associates /ID# 261571

Houston, Texas, United States

Prime Clinical Research - Mansfield - East Broad Street /ID# 262947

Mansfield, Texas, United States

ClinPoint Trials /ID# 251534

Waxahachie, Texas, United States

UMHAT Sveti Georgi /ID# 250808

Plovdiv, , Bulgaria

UMHAT Kanev /ID# 248931

Rousse, , Bulgaria

Acibadem City Clinic Tokuda University Hospital EAD /ID# 251232

Sofia, , Bulgaria

Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 251229

Sofia, , Bulgaria

Nova Clinic /ID# 249023

Varna, , Bulgaria

Klinicki bolnicki centar Sestre milosrdnice /ID# 252798

Zagreb, City of Zagreb, Croatia

Klinicki bolnicki centar Zagreb /ID# 252796

Zagreb, City of Zagreb, Croatia

Klinika za dječje bolesti Zagreb /ID# 252792

Zagreb, City of Zagreb, Croatia

Klinicki bolnicki centar Osijek /ID# 252795

Osijek, County of Osijek-Baranja, Croatia

Universitaetsklinikum Muenster /ID# 251965

Münster, North Rhine-Westphalia, Germany

Kinderarztpraxis Dr. Froehlich /ID# 252050

Forchheim, , Germany

HELIOS Klinikum Wuppertal /ID# 249022

Wuppertal, , Germany

Debreceni Egyetem-Klinikai Kozpont /ID# 250793

Debrecen, Hajdú-Bihar, Hungary

Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 252485

Belgrade, Beograd, Serbia

University Children's Hospital 'Tirsova' /ID# 252483

Belgrade, Beograd, Serbia

Institute for Child and Youth Health Care of Vojvodina /ID# 252482

Novi Sad, , Serbia

Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 252298

London, Greater London, United Kingdom

Great Ormond Street Children's Hospital /ID# 253333

London, Greater London, United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 252299

Norwich, Norfolk, United Kingdom

Russells Hall Hospital /ID# 252660

Dudley, , United Kingdom

Countries

United States; Bulgaria; Croatia; Germany; Hungary; Serbia; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.abbvieclinicaltrials.com/study/?id=M21-862

Related Info

Other Identifiers

2022-501947-34-00

Identifier Type: OTHER

Identifier Source: secondary_id

M21-862

Identifier Type: -

Identifier Source: org_study_id