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Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C) ((IBS-C))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03596905
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Description
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Brief Summary:
This study of the efficacy and safety of Plecanatide in children 6 to <18 Years of Age with Irritable Bowel Syndrome with Constipation (IBS-C)

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Constipation Drug: Plecanatide Drug: Matching placebo Phase 2

Detailed Description:

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetic (PK) parameters of plecanatide of once daily oral 4 dose levels of plecanatide (0.5, 1.0, 2.0, or 3.0 mg) for 4 weeks as treatment in children 6 to <18 years of age with IBS-C.

The study will include a 28-day Screening/Baseline Period, a 4 week treatment period, and a 2-week post-treatment follow-up period. Patients/caregivers will visit the clinic 4 times during the study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-Controlled, Dose Ranging, Parallel-Group Study of the Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)
Actual Study Start Date : June 30, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Plecanatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: 0.5 mg plecanatide
Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old
 Drug: Plecanatide
Taken orally daily for 4 weeks
Other Name: Trulance
Experimental: 1.0 mg plecanatide
Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old Group B: 12 to < 18 years old
 Drug: Plecanatide
Taken orally daily for 4 weeks
Other Name: Trulance
Experimental: 2.0 mg plecanatide
Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to < 18 years old
 Drug: Plecanatide
Taken orally daily for 4 weeks
Other Name: Trulance
Experimental: 3.0 mg plecanatide
Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to < 18 years old
 Drug: Plecanatide
Taken orally daily for 4 weeks
Other Name: Trulance
Placebo Comparator: Matching placebo
Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old Group B: 12 to < 18 years old
 Drug: Matching placebo
Taken orally daily for 4 weeks
Other Name: No other names


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in weekly SBM frequency over the 4 Week Treatment Period compared to placebo and across treatment groups [ Time Frame: 4 Week ]

Secondary Outcome Measures :
  1. Change from baseline in frequency and severity of abdominal pain/discomfort [ Time Frame: 4 Week ]
  2. Change from baseline in frequency of BMs and CSBMs [ Time Frame: 4 Week ]
  3. Change from baseline in stool consistency (BSFS or mBSFS-C) [ Time Frame: 4 Week ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

A patient will be eligible for study participation if he or she meets all of the following criteria:

  1. Male or female child aged 6 to < 18;
  2. Meets ROME IV criteria for child/adolescent IBS-C
  3. Patient's parent/guardian/LAR is able to voluntarily provide written, signed, and dated consent and patient is able to voluntarily provide assent as per IRB guidance;
  4. Patient and patient's parent/guardian/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures

EXCLUSION CRITERIA

A patient will be excluded from the study if he or she meets any of the following 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 is pregnant or lactating;
  4. The patient's mobility or normal exercise tolerance is compromised in the investigator's opinion;
  5. The patient has been screened for or participated in another Synergy study in the past;
  6. The patient has a sibling that is currently participating or has participated in another Synergy study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596905


Contacts
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Contact: Susan Harris 908-300-9220 susan.harris@bauschhealth.com

Locations
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United States, California
Synergy Research Site Recruiting
Corona, California, United States, 92879
United States, Florida
Synergy Research Site Recruiting
Doral, Florida, United States, 33122
Synergy Research Site Recruiting
Hialeah, Florida, United States, 33012
Synergy Research Site Recruiting
Miami, Florida, United States, 33134
Synergy Research Site Recruiting
Miami, Florida, United States, 33136
Synergy Research Site Recruiting
Miami, Florida, United States, 33155
Synergy Research Site Recruiting
Tampa, Florida, United States, 33607
United States, Louisiana
Synergy Research Site Recruiting
Crowley, Louisiana, United States, 70526
United States, Texas
Synergy Research Site Recruiting
Houston, Texas, United States, 77061
Synergy Research Site Recruiting
San Antonio, Texas, United States, 78215
United States, Virginia
Synergy Research Site Recruiting
Newport News, Virginia, United States, 23606
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: John Lahey Bausch Health
More Information
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT03596905    
Other Study ID Numbers: SP304202-14
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Plecanatide
Guanylyl Cyclase C Agonists
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents