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Chronic Idiopathic ConstipationPhase 2NCT03120520

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

A Phase 2 study testing Plecanatide in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Chronic Idiopathic Constipation
What is being tested?
Plecanatide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
36 sitesUnited States
Study dates
Jan 2017to 7 Sep 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Synergy Research Site

    Bellevue, Nebraska

  • Synergy Research Site

    Cerritos, California

  • Synergy Research Site

    Cincinnati, Ohio

  • Synergy Research Site

    Columbus, Ohio

  • Synergy Research Site

    Corona, California

  • Synergy Research Site

    Corpus Christi, Texas

  • Synergy Research Site

    Crowley, Louisiana

  • Synergy Research Site

    Dayton, Ohio

  • Synergy Research Site

    DeLand, Florida

  • Synergy Research Site

    Doral, Florida

  • Synergy Research Site

    Downey, California

  • Synergy Research Site

    Fayetteville, North Carolina

  • Synergy Research Site

    Foley, Alabama

  • Synergy Research Site

    Gresham, Oregon

  • Synergy Research Site

    Hialeah, Florida

  • Synergy Research Site

    Houston, Texas

  • Synergy Research Site

    Huntington Beach, California

  • Synergy Research Site

    Idaho Falls, Idaho

  • Synergy Research Site

    Jackson, Tennessee

  • Synergy Research Site

    Jonesboro, Arkansas

  • Synergy Research Site

    Kingsport, Tennessee

  • Synergy Research Site

    McAllen, Texas

  • Synergy Research Site

    Memphis, Tennessee

  • Synergy Research Site

    Meridian, Idaho

  • Synergy Research Site

    Miami, Florida

  • Synergy Research Site

    Newport News, Virginia

  • Synergy Research Site

    Nicholasville, Kentucky

  • Synergy Research Site

    Omaha, Nebraska

  • Synergy Research Site

    Orlando, Florida

  • Synergy Research Site

    Sacramento, California

  • Synergy Research Site

    San Antonio, Texas

  • Synergy Research Site

    Snellville, Georgia

  • Synergy Research Site

    Tampa, Florida

  • Synergy Research Site

    Thomaston, Georgia

  • Synergy Research Site

    Ventura, California

  • Synergy Research Site

    Wilmington, Delaware

Other trials in United States

About this study

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)

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

Read the 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.

Being tested
Plecanatide, Matching placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlecanatideDrug

    Also called Trulance

  • Matching placeboDrug

    Also called No other names

Study groups in NCT03120520
Study groupRoleWhat they receive
Plecanatide 0.5 mgExperimentalTaken orally once daily in the morning for 8 weeks
Receives: Drug: Plecanatide
Plecanatide 1.0 mgExperimentalTaken orally once daily in the morning for 8 weeks
Receives: Drug: Plecanatide
Plecanatide 1.5 mgExperimentalTaken orally once daily in the morning for 8 weeks
Receives: Drug: Plecanatide
Matching placeboPlacebo comparatorTaken orally once daily in the morning for 8 weeks
Receives: Drug: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 8 weeks

Secondary outcomes (3)

  1. 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.

    Measured: 8 weeks

  2. 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

    Measured: 8 weeks

  3. 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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2017
  2. Study startJan 2017
  3. Primary completion7 Sep 2018
  4. Study completion7 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03120520
Sponsor's protocol ID
SP304202-13
Status last verified
Aug 2019
First submitted
18 Apr 2017
Last updated
4 Oct 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Plecanatide in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Overall Responders (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03120520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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