Long Term Safety Study of Plecanatide



Status:Completed
Conditions:Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 85
Updated:10/7/2017
Start Date:January 2016
End Date:June 2017

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An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Multi-center, open-label, long-term safety study

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.

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.
We found this trial at
203
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DeLand, Florida 32720
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Albuquerque, New Mexico 87108
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Anderson, South Carolina 29621
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Artesia, California 90701
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Athens, Alabama
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Atlanta, Georgia 30312
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Atlantis, Florida
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Austin, Texas 78745
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Beavercreek, Ohio 45432
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Bellevue, Washington
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Birmingham, Alabama 35242
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Blackfoot, Idaho 83221
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Blue Island, Illinois
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Boise, Idaho 83709
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Boynton Beach, Florida 33426
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Bristol, Connecticut 06010
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Brooklyn, New York 11206
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Carmichael, California 95608
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Cary, North Carolina 27518
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Chandler, Arizona 85224
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Channelview, Texas 77530
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Charleston, West Virginia
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Charlotte, North Carolina 28210
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Chattanooga, Tennessee 37421
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Chesterfield, Michigan 48047
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Chicago, Illinois 60602
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Chula Vista, California 91910
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Cincinnati, Ohio 45246
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Clearwater, Florida 33759
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Corona, California 92879
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130 East Alton Avenue
Costa Mesa, California 92707
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Crowley, Louisiana
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Cutler Bay, Florida 33189
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Dayton, Ohio 45424
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Denver, Colorado 80220
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Encino, California 91436
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Fountain Valley, California 92708
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Franklin, Tennessee 37064
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Garden Grove, California 92843
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Great Neck, New York 11023
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Greer, South Carolina 29651
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Hermitage, Tennessee
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Hialeah, Florida 33012
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High Point, North Carolina 27262
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Hoffman Estates, Illinois
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Homestead, Florida 33030
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Houston, Texas 77081
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Humble, Texas 77338
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7451 Warner Avenue
Huntington Beach, California 92647
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Kettering, Ohio 45429
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