Does your child struggle with chronic constipation?

Your child may be eligible to participate in a research study. Qualified volunteers will receive study-related medications and examinations at no cost.

Does your child struggle with chronic constipation? Your child may be eligible to participate in a research study. Qualified volunteers will receive study-related medications and examinations at no cost.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Chronic Idiopathic Constipation Clinical Trial

NCT03120520 | Phase 2 | Interventional

Does your child struggle with chronic constipation?

Your child may be eligible to participate in a research study. Qualified volunteers will receive study-related medications and examinations at no cost.

Completed

Male & Female

12 - 17

Years old

This study has recruited 124 Participants

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

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Details for the study

Brief Title

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

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)

Brief Summary

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

Detailed 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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

Study 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.