Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)



Status:Recruiting
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 81
Updated:4/21/2016
Start Date:August 2013
End Date:December 2015
Contact:Laura Barrow, PharmD
Email:lbarrow@synergypharma.com
Phone:212-297-0020

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Trial Summary
Trial Overview
Inclusion Criteria

An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)

This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in
patients with Chronic Idiopathic Constipation (CIC).

This is an open-label extension study of plecanatide in the treatment of patients with CIC
who previously completed Synergy Protocols SP304-20210 and SP304203-00 (The CIC3 Study).

The planned duration of each patient's study participation is up to 411 days, including up
to 33 days of screening, 8 study visits over 52 weeks of treatment and a follow-up visit 2
weeks after the last dose of study drug.

Inclusion Criteria:

- Patient completed a previous double-blind plecanatide study and was compliant with
the study requirements.

- Patient is in good health without unstable acute illness or exacerbation of an
unstable chronic illness or chronic disease that may affect study assessments,
particularly if there has been a significant change to health status since the
previous plecanatide study.

Exclusion Criteria:

- Patient has had major surgery including laparoscopic procedures requiring general
anesthesia within 60 days of Day 1.

- Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency
virus (HIV) infection.

- Patient has taken a protocol-prohibited drug without the appropriate washout period.
We found this trial at
211
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Synergy Research Site
Stow, Ohio 44224
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Albuquerque, New Mexico 87108
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Albuquerque, New Mexico 87108
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Anaheim, California 92801
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Anaheim, California 92801
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Anderson, South Carolina 29621
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Artesia, California 90701
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Athens, Georgia 30606
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Atlanta, Georgia 30312
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Augusta, Kansas 67010
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Austin, Texas 78745
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Austin, Texas 78745
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Bastrop, Louisiana 71220
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Beavercreek, Ohio 45432
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Biloxi, Mississippi 39531
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Birmingham, Alabama 35242
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Blackfoot, Idaho 83221
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Boston, Massachusetts 02131
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Boynton Beach, Florida 33426
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Brandon, Florida 33511
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Bristol, Connecticut 06010
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Brooklyn, New York 11206
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Brownsburg, Indiana 46112
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Carlsbad, California 92008
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Cary, North Carolina 27518
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Centerville, Ohio 45459
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Cerritos, California 90703
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Chandler, Arizona 85224
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Channelview, Texas 77530
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Chapel Hill, North Carolina 27599
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Charleston, South Carolina 29406
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Charlotte, North Carolina 28210
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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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Chevy Chase, Maryland 20815
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Chicago, Illinois 60602
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Christiansburg, Virginia 24073
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Chula Vista, California 91910
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Cincinnati, Ohio 45246
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Cincinnati, Ohio 45246
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Clearwater, Florida 33759
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Clearwater, Florida 33759
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Cleveland, Ohio 44122
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Clive, Iowa 50325
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Colorado Springs, Colorado 80907
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Colorado Springs, Colorado 80907
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Colorado Springs, Colorado 80907
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Columbia, South Carolina 29203
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Corona, California 92879
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Cutler Bay, Florida 33189
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Dallas, Texas 75231
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Dallas, Texas 75231
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Decatur, Georgia 30032
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Decatur, Georgia 30032
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DeLand, Florida 32720
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Denver, Colorado 80220
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Denver, Colorado 80220
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Denver, Colorado 80220
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Dothan, Alabama 36305
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Elizabeth, New Jersey 07202
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Encinitas, California 92024
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Fargo, North Dakota 58103
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Flint, Michigan 48504
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Fort Lauderdale, Florida 33306
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Fountain Valley, California 92708
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Franklin, Tennessee 37064
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Fresno, California 93726
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Grand Island, Nebraska 68803
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Great Neck, New York 11023
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Greensboro, North Carolina 27403
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Gulf Shores, Alabama 36542
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Hawaiian Gardens, California 90716
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Henderson, Nevada 89014
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Henrico, Virginia 23233
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Hialeah, Florida 33012
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Hialeah, Florida 33012
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Hialeah, Florida 33012
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Homestead, Florida 33030
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Houston, Texas 77081
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Houston, Texas 77081
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Houston, Texas 77081
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Houston, Texas 77081
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Houston, Texas 77081
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Houston, Texas 77081
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Huber Heights, Ohio 45424
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Humble, Texas 77338
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Huntsville, Alabama 35801
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Jackson, Mississippi 39202
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Jackson, Tennessee 38305
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Jupiter, Florida 33458
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Katy, Texas 77450
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Kelowna, British Columbia
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Kinston, North Carolina 28501
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Knoxville, Tennessee 37912
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La Mirada, California 90638
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Laguna Hills, California 92653
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Lakeland, Florida 33805
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Lancaster, California 93534
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Las Vegas, Nevada 89102
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Las Vegas, Nevada 89102
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