CompletedPhase 2

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

United States19 participantsStarted 2023-04-27

Plain-language 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.

Who can participate

Age range6 Months – 23 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: * C…

What they're measuring

Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period

Timeframe: Baseline to Week 4

Change From Baseline in Stool Consistency (Bristol Stool Form Scale) During the Study Intervention Period

Timeframe: Baseline to Week 4

Change From Baseline in Straining During the Study Intervention Period

Timeframe: Baseline to Week 4

Number of Participants With Adverse Events (AEs)

Timeframe: Up to Week 5

Trial details

NCT IDNCT05760313

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-09

Results submitted2025-12-03

View on ClinicalTrials.gov More Functional Constipation trials

Plain-language summary

Who can participate

Age range6 Months – 23 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period

Timeframe: Baseline to Week 4

Change From Baseline in Stool Consistency (Bristol Stool Form Scale) During the Study Intervention Period

Timeframe: Baseline to Week 4

Change From Baseline in Straining During the Study Intervention Period

Timeframe: Baseline to Week 4

Number of Participants With Adverse Events (AEs)

Timeframe: Up to Week 5