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
sites
Synergy Research Site
Tampa, Florida 33606
2528
mi
from 98109
Tampa, FL
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Synergy Research Site
Albuquerque, New Mexico 87108
1187
mi
from 98109
Albuquerque, NM
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Synergy Research Site
Albuquerque, New Mexico 87108
1187
mi
from 98109
Albuquerque, NM
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Synergy Research Site
Anaheim, California 92801
979
mi
from 98109
Anaheim, CA
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Synergy Research Site
Anaheim, California 92801
979
mi
from 98109
Anaheim, CA
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Synergy Research Site
Anderson, South Carolina 29621
2227
mi
from 98109
Anderson, SC
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Synergy Research Site
Artesia, California 90701
976
mi
from 98109
Artesia, CA
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Synergy Research Site
Athens, Georgia 30606
2214
mi
from 98109
Athens, GA
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Synergy Research Site
Atlanta, Georgia 30312
2179
mi
from 98109
Atlanta, GA
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Synergy Research Site
Augusta, Kansas 67010
1451
mi
from 98109
Augusta, KS
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Synergy Research Site
Austin, Texas 78745
1771
mi
from 98109
Austin, TX
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Synergy Research Site
Austin, Texas 78745
1771
mi
from 98109
Austin, TX
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Synergy Research Site
Bastrop, Louisiana 71220
1889
mi
from 98109
Bastrop, LA
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Synergy Research Site
Beavercreek, Ohio 45432
1965
mi
from 98109
Beavercreek, OH
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Synergy Research Site
Biloxi, Mississippi 39531
2125
mi
from 98109
Biloxi, MS
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Synergy Research Site
Birmingham, Alabama 35242
2089
mi
from 98109
Birmingham, AL
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Synergy Research Site
Blackfoot, Idaho 83221
573
mi
from 98109
Blackfoot, ID
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Synergy Research Site
Boston, Massachusetts 02131
2484
mi
from 98109
Boston, MA
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Synergy Research Site
Boynton Beach, Florida 33426
2699
mi
from 98109
Boynton Beach, FL
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Synergy Research Site
Brandon, Florida 33511
2535
mi
from 98109
Brandon, FL
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Synergy Research Site
Bristol, Connecticut 06010
2420
mi
from 98109
Bristol, CT
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Synergy Research Site
Brooklyn, New York 11206
2405
mi
from 98109
Brooklyn, NY
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Synergy Research Site
Brownsburg, Indiana 46112
1854
mi
from 98109
Brownsburg, IN
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Synergy Research Site
Carlsbad, California 92008
1035
mi
from 98109
Carlsbad, CA
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Synergy Research Site
Cary, North Carolina 27518
2357
mi
from 98109
Cary, NC
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Synergy Research Site
Centerville, Ohio 45459
1964
mi
from 98109
Centerville, OH
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Synergy Research Site
Cerritos, California 90703
977
mi
from 98109
Cerritos, CA
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Synergy Research Site
Chandler, Arizona 85224
1128
mi
from 98109
Chandler, AZ
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Synergy Research Site
Channelview, Texas 77530
1899
mi
from 98109
Channelview, TX
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Synergy Research Site
Chapel Hill, North Carolina 27599
2337
mi
from 98109
Chapel Hill, NC
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Synergy Research Site
Charleston, South Carolina 29406
2412
mi
from 98109
Charleston, SC
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Synergy Research Site
Charlotte, North Carolina 28210
2284
mi
from 98109
Charlotte, NC
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Synergy Research Site
Charlotte, North Carolina 28210
2284
mi
from 98109
Charlotte, NC
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Synergy Research Site
Chattanooga, Tennessee 37421
2090
mi
from 98109
Chattanooga, TN
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Synergy Research Site
Chesterfield, Michigan 48047
1936
mi
from 98109
Chesterfield, MI
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Synergy Research Site
Chevy Chase, Maryland 20815
2316
mi
from 98109
Chevy Chase, MD
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Synergy Research Site
Chicago, Illinois 60602
1733
mi
from 98109
Chicago, IL
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Synergy Research Site
Christiansburg, Virginia 24073
2228
mi
from 98109
Christiansburg, VA
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Synergy Research Site
Chula Vista, California 91910
1072
mi
from 98109
Chula Vista, CA
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Synergy Research Site
Cincinnati, Ohio 45246
1963
mi
from 98109
Cincinnati, OH
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Synergy Research Site
Cincinnati, Ohio 45246
1963
mi
from 98109
Cincinnati, OH
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Synergy Research Site
Clearwater, Florida 33759
2515
mi
from 98109
Clearwater, FL
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Synergy Research Site
Clearwater, Florida 33759
2515
mi
from 98109
Clearwater, FL
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Synergy Research Site
Cleveland, Ohio 44122
2030
mi
from 98109
Cleveland, OH
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Synergy Research Site
Clive, Iowa 50325
1455
mi
from 98109
Clive, IA
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Synergy Research Site
Colorado Springs, Colorado 80907
1065
mi
from 98109
Colorado Springs, CO
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Synergy Research Site
Colorado Springs, Colorado 80907
1065
mi
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Colorado Springs, CO
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Synergy Research Site
Colorado Springs, Colorado 80907
1065
mi
from 98109
Colorado Springs, CO
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Synergy Research Site
Columbia, South Carolina 29203
2316
mi
from 98109
Columbia, SC
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Synergy Research Site
Corona, California 92879
982
mi
from 98109
Corona, CA
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Synergy Research Site
Cutler Bay, Florida 33189
2735
mi
from 98109
Cutler Bay, FL
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Synergy Research Site
Dallas, Texas 75231
1677
mi
from 98109
Dallas, TX
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Synergy Research Site
Dallas, Texas 75231
1677
mi
from 98109
Dallas, TX
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Synergy Research Site
Decatur, Georgia 30032
2185
mi
from 98109
Decatur, GA
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Synergy Research Site
Decatur, Georgia 30032
2185
mi
from 98109
Decatur, GA
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Synergy Research Site
DeLand, Florida 32720
2527
mi
from 98109
DeLand, FL
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Synergy Research Site
Denver, Colorado 80220
1023
mi
from 98109
Denver, CO
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Synergy Research Site
Denver, Colorado 80220
1023
mi
from 98109
Denver, CO
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Synergy Research Site
Denver, Colorado 80220
1023
mi
from 98109
Denver, CO
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Synergy Research Site
Dothan, Alabama 36305
2240
mi
from 98109
Dothan, AL
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Synergy Research Site
Elizabeth, New Jersey 07202
2394
mi
from 98109
Elizabeth, NJ
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Synergy Research Site
Encinitas, California 92024
1042
mi
from 98109
Encinitas, CA
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Synergy Research Site
Fargo, North Dakota 58103
1192
mi
from 98109
Fargo, ND
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Synergy Research Site
Flint, Michigan 48504
1880
mi
from 98109
Flint, MI
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Synergy Research Site
Fort Lauderdale, Florida 33306
2716
mi
from 98109
Fort Lauderdale, FL
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Synergy Research Site
Fountain Valley, California 92708
988
mi
from 98109
Fountain Valley, CA
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Synergy Research Site
Franklin, Tennessee 37064
1976
mi
from 98109
Franklin, TN
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Synergy Research Site
Fresno, California 93726
760
mi
from 98109
Fresno, CA
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Synergy Research Site
Grand Island, Nebraska 68803
1252
mi
from 98109
Grand Island, NE
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Synergy Research Site
Great Neck, New York 11023
2412
mi
from 98109
Great Neck, NY
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Synergy Research Site
Greensboro, North Carolina 27403
2295
mi
from 98109
Greensboro, NC
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Synergy Research Site
Gulf Shores, Alabama 36542
2187
mi
from 98109
Gulf Shores, AL
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Synergy Research Site
Hawaiian Gardens, California 90716
979
mi
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Hawaiian Gardens, CA
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Synergy Research Site
Henderson, Nevada 89014
882
mi
from 98109
Henderson, NV
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Synergy Research Site
Henrico, Virginia 23233
2339
mi
from 98109
Henrico, VA
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Synergy Research Site
Hialeah, Florida 33012
2722
mi
from 98109
Hialeah, FL
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Synergy Research Site
Hialeah, Florida 33012
2722
mi
from 98109
Hialeah, FL
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Synergy Research Site
Hialeah, Florida 33012
2722
mi
from 98109
Hialeah, FL
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Synergy Research Site
Homestead, Florida 33030
2734
mi
from 98109
Homestead, FL
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Synergy Research Site
Houston, Texas 77081
1888
mi
from 98109
Houston, TX
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Synergy Research Site
Houston, Texas 77081
1888
mi
from 98109
Houston, TX
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Synergy Research Site
Houston, Texas 77081
1888
mi
from 98109
Houston, TX
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Synergy Research Site
Houston, Texas 77081
1888
mi
from 98109
Houston, TX
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Synergy Research Site
Houston, Texas 77081
1888
mi
from 98109
Houston, TX
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Synergy Research Site
Houston, Texas 77081
1888
mi
from 98109
Houston, TX
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Synergy Research Site
Huber Heights, Ohio 45424
1960
mi
from 98109
Huber Heights, OH
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Synergy Research Site
Humble, Texas 77338
1882
mi
from 98109
Humble, TX
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Synergy Research Site
Huntsville, Alabama 35801
2039
mi
from 98109
Huntsville, AL
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Synergy Research Site
Jackson, Mississippi 39202
1983
mi
from 98109
Jackson, MS
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Synergy Research Site
Jackson, Tennessee 38305
1900
mi
from 98109
Jackson, TN
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Synergy Research Site
Jupiter, Florida 33458
2680
mi
from 98109
Jupiter, FL
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Synergy Research Site
Katy, Texas 77450
1876
mi
from 98109
Katy, TX
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Synergy Research Site
Kelowna, British Columbia
202
mi
from 98109
Kelowna,
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Synergy Research Site
Kinston, North Carolina 28501
2431
mi
from 98109
Kinston, NC
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Synergy Research Site
Knoxville, Tennessee 37912
2105
mi
from 98109
Knoxville, TN
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Synergy Research Site
La Mirada, California 90638
974
mi
from 98109
La Mirada, CA
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Synergy Research Site
Laguna Hills, California 92653
999
mi
from 98109
Laguna Hills, CA
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Synergy Research Site
Lakeland, Florida 33805
2543
mi
from 98109
Lakeland, FL
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Synergy Research Site
Lancaster, California 93534
919
mi
from 98109
Lancaster, CA
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Synergy Research Site
Las Vegas, Nevada 89102
874
mi
from 98109
Las Vegas, NV
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Synergy Research Site
Las Vegas, Nevada 89102
874
mi
from 98109
Las Vegas, NV
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