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

NCT03120520 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SP304202-13
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 36

Brief Summary

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

Conditions

Chronic Idiopathic Constipation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score

  8 weeks

• Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)

  8 weeks

• Change From Baseline in the Weekly Rate of Complete Spontaneous Bowel Movements (CSBM)

  8 weeks

Study Arms (4)

Plecanatide 0.5 mg

EXPERIMENTAL

Taken orally once daily in the morning for 8 weeks

Drug: Plecanatide

Plecanatide 1.0 mg

EXPERIMENTAL

Taken orally once daily in the morning for 8 weeks

Drug: Plecanatide

Plecanatide 1.5 mg

EXPERIMENTAL

Taken orally once daily in the morning for 8 weeks

Drug: Plecanatide

Matching placebo

PLACEBO COMPARATOR

Taken orally once daily in the morning for 8 weeks

Drug: Matching placebo

Interventions

Plecanatide DRUG

Also known as: Trulance

Plecanatide 0.5 mg; Plecanatide 1.0 mg; Plecanatide 1.5 mg

Matching placebo DRUG

Also known as: No other names

Matching placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female adolescents 12 to less than 18 years of age.
• Diagnosed with CIC based on the Rome III criteria for child/adolescent functional constipation (Appendix A).
• 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.
• 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.

You may not qualify if:

• The patient has a mental age \<4 years in the investigator's opinion.
• The patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation.
• 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.
• 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.
• 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.
• The patient's mobility or normal exercise tolerance is compromised in the investigator's opinion.
• The patient has a history of an eating disorder.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (36)

Synergy Research Site

Foley, Alabama, United States

Location

Synergy Research Site

Jonesboro, Arkansas, United States

Location

Synergy Research Site

Cerritos, California, United States

Location

Synergy Research Site

Corona, California, United States

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Synergy Research Site

Downey, California, United States

Location

Synergy Research Site

Huntington Beach, California, United States

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Synergy Research Site

Sacramento, California, United States

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Synergy Research Site

Ventura, California, United States

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Synergy Research Site

Wilmington, Delaware, United States

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Synergy Research Site

DeLand, Florida, United States

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Synergy Research Site

Doral, Florida, United States

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Synergy Research Site

Hialeah, Florida, United States

Location

Synergy Research Site

Miami, Florida, United States

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Synergy Research Site

Orlando, Florida, United States

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Synergy Research Site

Tampa, Florida, United States

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Synergy Research Site

Snellville, Georgia, United States

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Synergy Research Site

Thomaston, Georgia, United States

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Synergy Research Site

Idaho Falls, Idaho, United States

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Synergy Research Site

Meridian, Idaho, United States

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Synergy Research Site

Nicholasville, Kentucky, United States

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Synergy Research Site

Crowley, Louisiana, United States

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Synergy Research Site

Bellevue, Nebraska, United States

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Synergy Research Site

Omaha, Nebraska, United States

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Synergy Research Site

Fayetteville, North Carolina, United States

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Synergy Research Site

Cincinnati, Ohio, United States

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Synergy Research Site

Columbus, Ohio, United States

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Synergy Research Site

Dayton, Ohio, United States

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Synergy Research Site

Gresham, Oregon, United States

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Synergy Research Site

Jackson, Tennessee, United States

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Synergy Research Site

Kingsport, Tennessee, United States

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Synergy Research Site

Memphis, Tennessee, United States

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Synergy Research Site

Corpus Christi, Texas, United States

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Synergy Research Site

Houston, Texas, United States

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Synergy Research Site

McAllen, Texas, United States

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Synergy Research Site

San Antonio, Texas, United States

Location

Synergy Research Site

Newport News, Virginia, United States

Location

MeSH Terms

Interventions

plecanatide

Results Point of Contact

• Title: Clinical Operations Director
• Organization: Bausch Health Americas, Inc

lindsey.mathew@bauschhealth.com

908-927-0873

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 19, 2017
• Study Start: January 1, 2017
• Primary Completion: September 7, 2018
• Study Completion: September 7, 2018
• Last Updated: October 4, 2019
• Results First Posted: September 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (36)