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Long Term Safety Study of Plecanatide (IBS-C)

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Plecanatide
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with documented diagnosis of IBS-C who:

  • Completed plecanatide study SP304203-04 or SP304203-05, were compliant with the previous study's requirements, and did not experience any Serious Adverse Event (SAE) deemed related to study drug during the course of the previous study, OR
  • Failed screening in study SP304203-04 or SP304203-05 due to diary noncompliance (an exclusion in the core study) or due to an administrative reason and is allowed to enter this study by notification from Sponsor or delegate.

Key Exclusion Criteria:

  • Patient is unwilling or unable to: participate in the study for the required duration, understand and sign the informed consent form (ICF) and undergo all protocol related tests and procedures throughout the study.
  • Female patient of childbearing potential with a positive urine pregnancy test on Day 1.
  • Male and female patients of childbearing potential who do not agree to continue to use the method of birth control used in the core double-blind plecanatide study for the duration of this clinical trial.
  • Patient has experienced a significant negative change in health status during the course of participation in the core double-blind plecanatide study or after completion of the study.
  • In the opinion of the Investigator or Medical Monitor, it is not in the patient's best interest to participate in the study. The reason(s) for the patient's exclusion must be specified.

Sites / Locations

  • Synergy Research Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Plecanatide

Arm Description

Plecanatide 6.0 mg tablets

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Related Adverse Events.
Number of participants with adverse events with evidence to suggest a causal relationship between treatment and study drug.

Secondary Outcome Measures

Full Information

First Posted
February 29, 2016
Last Updated
August 5, 2020
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02706483
Brief Title
Long Term Safety Study of Plecanatide
Acronym
IBS-C
Official Title
An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Multi-center, open-label, long-term safety study
Detailed Description
This is a phase 3, multicenter, open-label, long-term safety and tolerability study of 6 mg daily dose of plecanatide administered orally. Patients who are Study Completers or Eligible Screen Failures whose eligibility is confirmed at the end of their participation in the double-blind plecanatide studies SP304203-04 or SP304203-05 will be enrolled. Beginning on Day 1, patients will take one (1) plecanatide 6.0 mg tablet in the clinic and thereafter every morning with approximately 240 mL (8 ounces) of liquid, with or without meals. Safety and tolerability assessments and patients' self-assessment of disease severity will be performed according to the Schedule of Assessments. Patients who discontinue early from the study will undergo an Early Withdrawal (EW) visit within 5 days after stopping study drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plecanatide
Arm Type
Experimental
Arm Description
Plecanatide 6.0 mg tablets
Intervention Type
Drug
Intervention Name(s)
Plecanatide
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Related Adverse Events.
Description
Number of participants with adverse events with evidence to suggest a causal relationship between treatment and study drug.
Time Frame
up to 53 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with documented diagnosis of IBS-C who: Completed plecanatide study SP304203-04 or SP304203-05, were compliant with the previous study's requirements, and did not experience any Serious Adverse Event (SAE) deemed related to study drug during the course of the previous study, OR Failed screening in study SP304203-04 or SP304203-05 due to diary noncompliance (an exclusion in the core study) or due to an administrative reason and is allowed to enter this study by notification from Sponsor or delegate. Key Exclusion Criteria: Patient is unwilling or unable to: participate in the study for the required duration, understand and sign the informed consent form (ICF) and undergo all protocol related tests and procedures throughout the study. Female patient of childbearing potential with a positive urine pregnancy test on Day 1. Male and female patients of childbearing potential who do not agree to continue to use the method of birth control used in the core double-blind plecanatide study for the duration of this clinical trial. Patient has experienced a significant negative change in health status during the course of participation in the core double-blind plecanatide study or after completion of the study. In the opinion of the Investigator or Medical Monitor, it is not in the patient's best interest to participate in the study. The reason(s) for the patient's exclusion must be specified.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Bulawski
Organizational Affiliation
Bausch Health
Official's Role
Study Director
Facility Information:
Facility Name
Synergy Research Site
City
Athens
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Alabama
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United States
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Birmingham
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Alabama
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Dothan
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Alabama
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Foley
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Guntersville
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Alabama
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Huntsville
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Alabama
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Saraland
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Alabama
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Chandler
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Arizona
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Phoenix
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Surprise
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Tucson
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Conway
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Glendale
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Little Rock
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Artesia
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Canoga Park
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Carmichael
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Chula Vista
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La Mesa
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DeLand
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Metairie
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Shreveport
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Hagerstown
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Marlborough
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Chesterfield
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Flint
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Wyoming
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Jackson
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Port Gibson
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Mississippi
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Chesterfield
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Missouri
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Hazelwood
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Missouri
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Saint Louis
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Missoula
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Montana
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Omaha
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Nebraska
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Marlton
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Albuquerque
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New Mexico
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Brooklyn
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New York
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Great Neck
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Hopewell Junction
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Kew Gardens
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New Windsor
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New York
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New York
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North Massapequa
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Poughkeepsie
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Cary
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Charlotte
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Charlotte
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North Carolina
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Davidson
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North Carolina
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Fayetteville
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High Point
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Country
United States
Facility Name
Synergy Research Site
City
Jacksonville
State/Province
North Carolina
Country
United States
Facility Name
Synergy Research Site
City
Kinston
State/Province
North Carolina
Country
United States
Facility Name
Synergy Research Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Synergy Research Site
City
Salisbury
State/Province
North Carolina
Country
United States
Facility Name
Synergy Research Site
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
Synergy Research Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Synergy Research Site
City
Fargo
State/Province
North Dakota
Country
United States
Facility Name
Synergy Research Site
City
Beavercreek
State/Province
Ohio
Country
United States
Facility Name
Synergy Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Synergy Research Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Synergy Research Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Synergy Research Site
City
Englewood
State/Province
Ohio
Country
United States
Facility Name
Synergy Research Site
City
Kettering
State/Province
Ohio
Country
United States
Facility Name
Synergy Research Site
City
Mentor
State/Province
Ohio
Country
United States
Facility Name
Synergy Research Site
City
Middleburg Heights
State/Province
Ohio
Country
United States
Facility Name
Synergy Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Synergy Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Synergy Research Site
City
Lansdale
State/Province
Pennsylvania
Country
United States
Facility Name
Synergy Research Site
City
Levittown
State/Province
Pennsylvania
Country
United States
Facility Name
Synergy Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Synergy Research Site
City
Smithfield
State/Province
Pennsylvania
Country
United States
Facility Name
Synergy Research Site
City
Anderson
State/Province
South Carolina
Country
United States
Facility Name
Synergy Research Site
City
Gaffney
State/Province
South Carolina
Country
United States
Facility Name
Synergy Research Site
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Synergy Research Site
City
Rapid City
State/Province
South Dakota
Country
United States
Facility Name
Synergy Research Site
City
Athens
State/Province
Tennessee
Country
United States
Facility Name
Synergy Research Site
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Synergy Research Site
City
Fayetteville
State/Province
Tennessee
Country
United States
Facility Name
Synergy Research Site
City
Franklin
State/Province
Tennessee
Country
United States
Facility Name
Synergy Research Site
City
Hermitage
State/Province
Tennessee
Country
United States
Facility Name
Synergy Research Site
City
Jackson
State/Province
Tennessee
Country
United States
Facility Name
Synergy Research Site
City
Kingsport
State/Province
Tennessee
Country
United States
Facility Name
Synergy Research Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Synergy Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Synergy Research Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Synergy Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
Beaumont
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
Carrollton
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
Channelview
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
Humble
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
Lampasas
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
McKinney
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
Missouri City
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
Plano
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
Port Arthur
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
Sugar Land
State/Province
Texas
Country
United States
Facility Name
Synergy Research Site
City
Ogden
State/Province
Utah
Country
United States
Facility Name
Synergy Research Site
City
Orem
State/Province
Utah
Country
United States
Facility Name
Synergy Research Site
City
Saint George
State/Province
Utah
Country
United States
Facility Name
Synergy Research Site
City
Sandy
State/Province
Utah
Country
United States
Facility Name
Synergy Research Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Synergy Research Site
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
Synergy Research Site
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
Synergy Research Site
City
Lynchburg
State/Province
Virginia
Country
United States
Facility Name
Synergy Research Site
City
Newport News
State/Province
Virginia
Country
United States
Facility Name
Synergy Research Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Synergy Research Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Synergy Research Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Synergy Research Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Synergy Research Site
City
Charleston
State/Province
West Virginia
Country
United States
Facility Name
Synergy Research Site
City
Kingwood
State/Province
West Virginia
Country
United States
Facility Name
Synergy Research Site
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
Synergy Research Site
City
La Crosse
State/Province
Wisconsin
Country
United States
Facility Name
Synergy Research Site
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30277094
Citation
Barish CF, Crozier RA, Griffin PH. Long-term treatment with plecanatide was safe and tolerable in patients with irritable bowel syndrome with constipation. Curr Med Res Opin. 2019 Jan;35(1):81-85. doi: 10.1080/03007995.2018.1527303. Epub 2018 Oct 9.
Results Reference
derived

Learn more about this trial

Long Term Safety Study of Plecanatide

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