Irritable Bowel Syndrome With Constipation Clinical Trial
— (IBS-C)Official title:
A Randomized, Double-blind, Placebo-Controlled, Dose Ranging, Parallel-Group Study of the Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)
This study of the efficacy and safety of Plecanatide in children 6 to <18 Years of Age with Irritable Bowel Syndrome with Constipation (IBS-C)
Status | Recruiting |
Enrollment | 210 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | INCLUSION CRITERIA A patient will be eligible for study participation if he or she meets all of the following criteria: 1. Male or female child aged 6 to < 18; 2. Meets ROME IV criteria for child/adolescent IBS-C 3. Patient's parent/guardian/LAR is able to voluntarily provide written, signed, and dated consent and patient is able to voluntarily provide assent as per IRB guidance; 4. Patient and patient's parent/guardian/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures EXCLUSION CRITERIA A patient will be excluded from the study if he or she meets any of the following criteria: 1. The patient has a mental age <4 years in the investigator's opinion; 2. The patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation; 3. The patient is pregnant or lactating; 4. The patient's mobility or normal exercise tolerance is compromised in the investigator's opinion; 5. The patient has been screened for or participated in another Synergy study in the past; 6. The patient has a sibling that is currently participating or has participated in another Synergy study. |
Country | Name | City | State |
---|---|---|---|
United States | Synergy Research Site | Corona | California |
United States | Synergy Research Site | Crowley | Louisiana |
United States | Synergy Research Site | Doral | Florida |
United States | Synergy Research Site | Hialeah | Florida |
United States | Synergy Research Site | Houston | Texas |
United States | Synergy Research Site | Miami | Florida |
United States | Synergy Research Site | Miami | Florida |
United States | Synergy Research Site | Miami | Florida |
United States | Synergy Research Site | Newport News | Virginia |
United States | Synergy Research Site | San Antonio | Texas |
United States | Synergy Research Site | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Bausch Health Americas, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in weekly SBM frequency over the 4 Week Treatment Period compared to placebo and across treatment groups | 4 Week | ||
Secondary | Change from baseline in frequency and severity of abdominal pain/discomfort | 4 Week | ||
Secondary | Change from baseline in frequency of BMs and CSBMs | 4 Week | ||
Secondary | Change from baseline in stool consistency (BSFS or mBSFS-C) | 4 Week |
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