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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Overview

Status
Completed
Phase
Phase 2
Enrollment
124 participants (actual)
Sponsor
Bausch Health Americas, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jan 2017
Primary completion
7 Sept 2018
Completion
7 Sept 2018
First posted
19 Apr 2017
Last update posted
4 Oct 2019
Conditions
Chronic Idiopathic Constipation

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 2

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

    NCT03120520

    Jan 2017 to 7 Sept 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • PlecanatideDrug
  • Matching placeboDrug

Arms4

  • Experimental

    Plecanatide 0.5 mg

    Taken orally once daily in the morning for 8 weeks

  • Experimental

    Plecanatide 1.0 mg

    Taken orally once daily in the morning for 8 weeks

  • Experimental

    Plecanatide 1.5 mg

    Taken orally once daily in the morning for 8 weeks

  • Placebo comparator

    Matching placebo

    Taken orally once daily in the morning for 8 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Proportion of Overall Responders

    Time frame · 8 weeks

    Registry description

    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.

Secondary outcomes(3)
  1. Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score

    Time frame · 8 weeks

    Registry description

    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.

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

    Time frame · 8 weeks

    Registry description

    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

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

    Time frame · 8 weeks

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 8 weeks

Proportion of Overall Responders

GroupValue (Participants)
Matching Placebo7
Plecanatide 0.5 mg10
Plecanatide 1.0 mg12
Plecanatide 1.5 mg7
Secondary and other outcome results(3)
Secondary outcomeLeast squares mean· 8 weeks

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

GroupValue (units on a scale)Spread
Matching Placebo0.980.209
Plecanatide 0.5 mg1.090.209
Plecanatide 1.0 mg1.220.205
Plecanatide 1.5 mg1.060.191
Secondary outcomeLeast squares mean· 8 weeks

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

GroupValue (Weekly SBMs)Spread
Matching Placebo1.440.332
Plecanatide 0.5 mg1.970.339
Plecanatide 1.0 mg2.060.343
Plecanatide 1.5 mg2.050.328
Secondary outcomeLeast squares mean· 8 weeks

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

GroupValue (Weekly CSBMs)Spread
Matching Placebo1.300.344
Plecanatide 0.5 mg1.710.348
Plecanatide 1.0 mg1.830.354
Plecanatide 1.5 mg2.110.340

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Matching PlaceboTaken orally once daily in the morning for 8 weeks Matching placebo0 / 310 / 314 / 31
Plecanatide 0.5 mgTaken orally once daily in the morning for 8 weeks Plecanatide0 / 310 / 317 / 31
Plecanatide 1.0 mgTaken orally once daily in the morning for 8 weeks Plecanatide0 / 300 / 304 / 30
Plecanatide 1.5 mgTaken orally once daily in the morning for 8 weeks Plecanatide0 / 320 / 323 / 32

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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