Clinical trial NCT03596905: Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Irritable Bowel Syndrome With Constipation
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 210
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: The purpose of this study is to evaluate the safety, efficacy and pharmacokinetic (PK) parameters of plecanatide of once daily oral 4 dose levels of plecanatide (0.5, 1.0, 2.0, or 3.0 mg) for 4 weeks as treatment in children 6 to \<18 years of age with IBS-C.

The study will include a 28-day Screening/Baseline Period, a 4 week treatment period, and a 2-week post-treatment follow-up period. Patients/caregivers will visit the clinic 4 times during the study.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in weekly SBM frequency over the 4 Week Treatment Period compared to placebo and across treatment groups
timeFrame: 4 Week
Secondary outcomes:
measure: Change from baseline in frequency and severity of abdominal pain/discomfort
timeFrame: 4 Week
measure: Change from baseline in frequency of BMs and CSBMs
timeFrame: 4 Week
measure: Change from baseline in stool consistency (BSFS or mBSFS-C)
timeFrame: 4 Week
Other outcomes:
Locations:
city: Corona
country: United States
facility: Synergy Research Site
state: California
city: Doral
country: United States
facility: Synergy Research Site
state: Florida
city: Hialeah
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Tampa
country: United States
facility: Synergy Research Site
state: Florida
city: Crowley
country: United States
facility: Synergy Research Site
state: Louisiana
city: Houston
country: United States
facility: Synergy Research Site
state: Texas
city: San Antonio
country: United States
facility: Synergy Research Site
state: Texas
city: Newport News
country: United States
facility: Synergy Research Site
state: Virginia
Study officials:
affiliation: Bausch Health
name: John Lahey
role: STUDY_DIRECTOR
References: