An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation

Chronic Idiopathic Constipation Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, 3 Dose Level, Parallel Group Study of the Efficacy and Safety of Plecanatide in Adolescents 12 to < 18 Years of Age With Chronic Idiopathic Constipation (CIC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120520
• Other study ID #: SP304202-13
• Status: Completed
• Phase: Phase 2
• Start date: January 2017
• Est. completion date: September 7, 2018

Study information

• Verified date: August 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to < 18 years diagnosed with Chronic Idiopathic Constipation.

Description:

The purpose of the study is to evaluate efficacy, safety, and pharmacokinetics (PK) of oral Plecanatide 0.5, 1.0 and 1.5 mg tablets dosed once a day as compared to matching placebo, when administered for 8 weeks in adolescents with chronic idiopathic constipation.

This study will consist of a 4-week screening period, 8 weeks of treatment, and a 2-week follow-up. The study will assess the effects of Plecanatide on bowel movement frequency and other clinical features of CIC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: September 7, 2018
• Est. primary completion date: September 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Key Inclusion Criteria:

1. Male or female adolescents 12 to less than 18 years of age.

2. Diagnosed with CIC based on the Rome III criteria for child/adolescent functional constipation (Appendix A).

3. Patient is able to voluntarily provide written, signed, and dated (personally and via a legally authorized representative [LAR]) assent/informed consent as applicable to participate in the study.

4. Subject's parent/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures (e.g., accept venipuncture, willing and able to swallow tablets, accept urine drug screen for opiates) and restrictions.

Key Exclusion 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 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.

4. The patient, if female of childbearing potential (defined as postmenarche), does not agree to practice 1 of the following medically acceptable methods of birth control throughout the study:

• Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient's usual menstrual cycle period) before study drug administration.

• Total abstinence from sexual intercourse since the last menses before study drug administration.

• Intrauterine device.

• Double barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream.

5. 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 weeks prior to Screening.

6. The patient's mobility or normal exercise tolerance is compromised in the investigator's opinion.

7. The patient has a history of an eating disorder.

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Drug:
• Plecanatide

• Matching placebo

Locations

Country	Name	City	State
United States	Synergy Research Site	Bellevue	Nebraska
United States	Synergy Research Site	Cerritos	California
United States	Synergy Research Site	Cincinnati	Ohio
United States	Synergy Research Site	Columbus	Ohio
United States	Synergy Research Site	Corona	California
United States	Synergy Research Site	Corpus Christi	Texas
United States	Synergy Research Site	Crowley	Louisiana
United States	Synergy Research Site	Dayton	Ohio
United States	Synergy Research Site	DeLand	Florida
United States	Synergy Research Site	Doral	Florida
United States	Synergy Research Site	Downey	California
United States	Synergy Research Site	Fayetteville	North Carolina
United States	Synergy Research Site	Foley	Alabama
United States	Synergy Research Site	Gresham	Oregon
United States	Synergy Research Site	Hialeah	Florida
United States	Synergy Research Site	Houston	Texas
United States	Synergy Research Site	Huntington Beach	California
United States	Synergy Research Site	Idaho Falls	Idaho
United States	Synergy Research Site	Jackson	Tennessee
United States	Synergy Research Site	Jonesboro	Arkansas
United States	Synergy Research Site	Kingsport	Tennessee
United States	Synergy Research Site	McAllen	Texas
United States	Synergy Research Site	Memphis	Tennessee
United States	Synergy Research Site	Meridian	Idaho
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Newport News	Virginia
United States	Synergy Research Site	Nicholasville	Kentucky
United States	Synergy Research Site	Omaha	Nebraska
United States	Synergy Research Site	Orlando	Florida
United States	Synergy Research Site	Sacramento	California
United States	Synergy Research Site	San Antonio	Texas
United States	Synergy Research Site	Snellville	Georgia
United States	Synergy Research Site	Tampa	Florida
United States	Synergy Research Site	Thomaston	Georgia
United States	Synergy Research Site	Ventura	California
United States	Synergy Research Site	Wilmington	Delaware

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	Proportion of Overall Responders	An Overall Responder is a participant who was a Spontaneous Bowel Movement (SBM) responder for the last 2 weeks of the Treatment Period. An SBM responder is defined as a participant who had >3 SBMs per week. SBM was defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours. Participants missing with respect to the outcome measure were scored as non-responders.	8 weeks
Secondary	Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score	Stool consistency was assessed via the 7-point (1-7) Bristol Stool Form Scale (BSFS) and recorded in the bowel movement (BM) and Symptom Diaries. Lower numbers represent more formed stools; higher numbers represent less formed stools. The weekly mean BSFS score per patient = (total of all BSFS scores reported for a corresponding Spontaneous Bowel Movement (SBM) per time period)/n, where n = number of SBMs scored during the time period. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS types were 1) separate hard lumps, like nuts (hard to pass); 2) sausage-shaped but lumpy; 3) like a sausage but with cracks on its surface; 4) like a sausage or snake, smooth and soft; 5) soft blobs with clear-cut edges (passed easily); 6) fluffy pieces with ragged edges, a mushy stool; 7) watery, no solid pieces, entirely liquid.	8 weeks
Secondary	Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)	The weekly Spontaneous Bowel Movement (SBM) totals were derived from the daily diary entries reported during the Treatment Period in the Bowel Movement (BM) and symptom diaries. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. SBM is defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours	8 weeks
Secondary	Change From Baseline in the Weekly Rate of Complete Spontaneous Bowel Movements (CSBM)	The weekly Complete Spontaneous Bowel Movement (CSBM) totals are derived from the daily diary entries reported during the Treatment Period in the Bowel Movement (BM) and symptom diaries. Baseline is the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. Spontaneous Bowel Movement (SBM) was defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours. CSBM was defined as a spontaneous bowel movement with the sense of complete evacuation.	8 weeks