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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03596905
Other study ID # SP304202-14
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 30, 2018
Est. completion date December 2023

Study information

Verified date February 2023
Source Bausch Health Americas, Inc.
Contact Susan Harris
Phone 908-300-9220
Email susan.harris@bauschhealth.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Plecanatide
Taken orally daily for 4 weeks
Matching placebo
Taken orally daily for 4 weeks

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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
See also
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