An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: Plecanatide; Matching placebo
Intervention MeSH terms: Plecanatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

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

Eligibility criteria:

        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.