An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
NCT ID: NCT03120520
Last Updated: 2019-10-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2017-01-31
2018-09-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Plecanatide 0.5 mg
Taken orally once daily in the morning for 8 weeks
Plecanatide
Plecanatide 1.0 mg
Taken orally once daily in the morning for 8 weeks
Plecanatide
Plecanatide 1.5 mg
Taken orally once daily in the morning for 8 weeks
Plecanatide
Matching placebo
Taken orally once daily in the morning for 8 weeks
Matching placebo
Interventions
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Plecanatide
Matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
12 Years
17 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Locations
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Synergy Research Site
Foley, Alabama, United States
Synergy Research Site
Jonesboro, Arkansas, United States
Synergy Research Site
Cerritos, California, United States
Synergy Research Site
Corona, California, United States
Synergy Research Site
Downey, California, United States
Synergy Research Site
Huntington Beach, California, United States
Synergy Research Site
Sacramento, California, United States
Synergy Research Site
Ventura, California, United States
Synergy Research Site
Wilmington, Delaware, United States
Synergy Research Site
DeLand, Florida, United States
Synergy Research Site
Doral, Florida, United States
Synergy Research Site
Hialeah, Florida, United States
Synergy Research Site
Miami, Florida, United States
Synergy Research Site
Orlando, Florida, United States
Synergy Research Site
Tampa, Florida, United States
Synergy Research Site
Snellville, Georgia, United States
Synergy Research Site
Thomaston, Georgia, United States
Synergy Research Site
Idaho Falls, Idaho, United States
Synergy Research Site
Meridian, Idaho, United States
Synergy Research Site
Nicholasville, Kentucky, United States
Synergy Research Site
Crowley, Louisiana, United States
Synergy Research Site
Bellevue, Nebraska, United States
Synergy Research Site
Omaha, Nebraska, United States
Synergy Research Site
Fayetteville, North Carolina, United States
Synergy Research Site
Cincinnati, Ohio, United States
Synergy Research Site
Columbus, Ohio, United States
Synergy Research Site
Dayton, Ohio, United States
Synergy Research Site
Gresham, Oregon, United States
Synergy Research Site
Jackson, Tennessee, United States
Synergy Research Site
Kingsport, Tennessee, United States
Synergy Research Site
Memphis, Tennessee, United States
Synergy Research Site
Corpus Christi, Texas, United States
Synergy Research Site
Houston, Texas, United States
Synergy Research Site
McAllen, Texas, United States
Synergy Research Site
San Antonio, Texas, United States
Synergy Research Site
Newport News, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SP304202-13
Identifier Type: -
Identifier Source: org_study_id
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