Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With ā¦ (NCT03596905) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)
United States218 participantsStarted 2018-06-30
Plain-language summary
The goal of this clinical trial is to learn if plecanatide can improve bowel function and relieve symptoms of irritable bowel syndrome with constipation (IBS-C) in children and adolescents aged 6 to \<18 years. The main questions it aims to answer are:
* Does plecanatide increase the number of spontaneous bowel movements (SBMs) compared to placebo?
* Is plecanatide safe and well tolerated in this pediatric population? Researchers will compare plecanatide at different doses to a placebo (a look-alike substance with no active drug) to see if plecanatide improves bowel function.
Participants will:
* Take plecanatide or placebo orally once daily for 4 weeks
* Complete daily symptom diaries
* Attend clinic visits for assessments and safety checks
Who can participate
Age range6 Years ā 18 Years
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
ā. Male or female child or adolescent age 6 to \< 18;
ā. Meets ROME IV criteria for child/adolescent IBS-C defined as:
ā. Abdominal pain at least 4 days per month associated with one or more of the following:
ā. Related to defecation
ā. A change in frequency of stool
ā. A change in form (appearance) of stool;
ā. The pain does not resolve with resolution of the constipation (children in whom the pain resolves have functional constipation, not irritable bowel syndrome);
ā. After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
Exclusion criteria
ā. The patient has a mental age \<4 years in the investigator's opinion;
ā. The patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation;
What they're measuring
1
Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups
ā. The patient currently requires iron supplements, amitriptyline, or other tricyclic antidepressants for depression, opioid-containing medications or compounds for pain, or has other conditions that require medications known to cause constipation. A patient with an onset of constipation prior to the use of these medications and who has been on a stable dose for at least 8 weeks prior to Screening might be considered eligible for this study if the investigator deems these medications do not significantly contribute to the patient's constipation. Screening of these patients needs to be approved by the medical monitor and the sponsor;
ā. The patient is pregnant or lactating;
ā. Females age 12 to \< 18 or females age 6 to 11 of childbearing potential (defined as post menarche) who does not agree to practice one of the following medically acceptable methods of birth control throughout the study;
ā. The patient follows a diet not considered normal by the investigator for the patient's age, relative to variety of food, caloric content, and quantity. The patient must have been on a stable diet for at least 30 days prior to Screening;
ā. The patient's mobility or normal exercise tolerance is compromised in the investigator's opinion;
ā. The patient has a history of an eating disorder;