Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation (NCT04110145) | Clinical Trial Compass
CompletedPhase 2
Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
United States35 participantsStarted 2019-10-14
Plain-language summary
The purpose of this study is to evaluate the dose response, safety, and efficacy of linaclotide when compared with placebo in pediatric participants, 2 to 5 years of age, with Functional Constipation.
Who can participate
Age range
2 Years – 5 Years
Sex
ALL
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
. 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 that may obstruct the toilet
. At least one episode of fecal incontinence per week after the acquisition of toileting skills
Exclusion criteria
. Improvement with defecation
. Onset associated with a change in frequency of stool
. Onset associated with a change in form (appearance) of stool
. Surgery to remove a segment of the GI tract at any time before Screening (Visit 1)
. Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit
. An appendectomy or cholecystectomy during the 60 days before Screening (Visit 1)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period of Each Cohort
Timeframe: Baseline (14 days prior to randomization) to Day 29
2
Change From Baseline in 4-week Stool Consistency Reported by the Caregiver During the Study Intervention Period of Each Cohort
Timeframe: Baseline (14 days prior to randomization) to Day 29
3
Change From Baseline in 4-week Straining Reported by the Caregiver During the Study Intervention Period of Each Cohort
Timeframe: Baseline (14 days prior to randomization) to Day 29
4
Percentage of Days With Fecal Incontinence During the Study Intervention Period (for Participants Who Have Acquired Toileting Skills During the Daytime and Nighttime or Acquired Toileting Skills During Daytime Only) Within Each Cohort
Timeframe: 29 Days
5
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Timeframe: First dose of study drug intervention to within 1 week of last dose (Up to 45 days)