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
Brooklyn, New York 11206
480
mi
from 43215
Brooklyn, NY
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Synergy Research Site
Albuquerque, New Mexico 87108
1329
mi
from 43215
Albuquerque, NM
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Synergy Research Site
Albuquerque, New Mexico 87108
1329
mi
from 43215
Albuquerque, NM
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Synergy Research Site
Anaheim, California 92801
1962
mi
from 43215
Anaheim, CA
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Synergy Research Site
Anaheim, California 92801
1962
mi
from 43215
Anaheim, CA
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Synergy Research Site
Anderson, South Carolina 29621
377
mi
from 43215
Anderson, SC
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Synergy Research Site
Artesia, California 90701
1968
mi
from 43215
Artesia, CA
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Synergy Research Site
Athens, Georgia 30606
416
mi
from 43215
Athens, GA
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Synergy Research Site
Atlanta, Georgia 30312
436
mi
from 43215
Atlanta, GA
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Synergy Research Site
Augusta, Kansas 67010
766
mi
from 43215
Augusta, KS
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Synergy Research Site
Austin, Texas 78745
1070
mi
from 43215
Austin, TX
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Synergy Research Site
Austin, Texas 78745
1070
mi
from 43215
Austin, TX
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Synergy Research Site
Bastrop, Louisiana 71220
699
mi
from 43215
Bastrop, LA
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Synergy Research Site
Beavercreek, Ohio 45432
58
mi
from 43215
Beavercreek, OH
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Synergy Research Site
Biloxi, Mississippi 39531
740
mi
from 43215
Biloxi, MS
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Synergy Research Site
Birmingham, Alabama 35242
495
mi
from 43215
Birmingham, AL
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Synergy Research Site
Blackfoot, Idaho 83221
1523
mi
from 43215
Blackfoot, ID
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Synergy Research Site
Boston, Massachusetts 02131
638
mi
from 43215
Boston, MA
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Synergy Research Site
Boynton Beach, Florida 33426
942
mi
from 43215
Boynton Beach, FL
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Synergy Research Site
Brandon, Florida 33511
832
mi
from 43215
Brandon, FL
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Synergy Research Site
Bristol, Connecticut 06010
539
mi
from 43215
Bristol, CT
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Synergy Research Site
Brownsburg, Indiana 46112
179
mi
from 43215
Brownsburg, IN
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Synergy Research Site
Carlsbad, California 92008
1948
mi
from 43215
Carlsbad, CA
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Synergy Research Site
Cary, North Carolina 27518
373
mi
from 43215
Cary, NC
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Synergy Research Site
Centerville, Ohio 45459
65
mi
from 43215
Centerville, OH
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Synergy Research Site
Cerritos, California 90703
1967
mi
from 43215
Cerritos, CA
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Synergy Research Site
Chandler, Arizona 85224
1655
mi
from 43215
Chandler, AZ
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Synergy Research Site
Channelview, Texas 77530
980
mi
from 43215
Channelview, TX
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Synergy Research Site
Chapel Hill, North Carolina 27599
353
mi
from 43215
Chapel Hill, NC
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Synergy Research Site
Charleston, South Carolina 29406
514
mi
from 43215
Charleston, SC
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Synergy Research Site
Charlotte, North Carolina 28210
354
mi
from 43215
Charlotte, NC
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Synergy Research Site
Charlotte, North Carolina 28210
354
mi
from 43215
Charlotte, NC
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Synergy Research Site
Chattanooga, Tennessee 37421
359
mi
from 43215
Chattanooga, TN
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Synergy Research Site
Chesterfield, Michigan 48047
186
mi
from 43215
Chesterfield, MI
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Synergy Research Site
Chevy Chase, Maryland 20815
324
mi
from 43215
Chevy Chase, MD
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Synergy Research Site
Chicago, Illinois 60602
274
mi
from 43215
Chicago, IL
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Synergy Research Site
Christiansburg, Virginia 24073
241
mi
from 43215
Christiansburg, VA
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Synergy Research Site
Chula Vista, California 91910
1948
mi
from 43215
Chula Vista, CA
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Synergy Research Site
Cincinnati, Ohio 45246
90
mi
from 43215
Cincinnati, OH
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Synergy Research Site
Cincinnati, Ohio 45246
90
mi
from 43215
Cincinnati, OH
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Synergy Research Site
Clearwater, Florida 33759
828
mi
from 43215
Clearwater, FL
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Synergy Research Site
Clearwater, Florida 33759
828
mi
from 43215
Clearwater, FL
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Synergy Research Site
Cleveland, Ohio 44122
131
mi
from 43215
Cleveland, OH
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Synergy Research Site
Clive, Iowa 50325
573
mi
from 43215
Clive, IA
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Synergy Research Site
Colorado Springs, Colorado 80907
1162
mi
from 43215
Colorado Springs, CO
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Synergy Research Site
Colorado Springs, Colorado 80907
1162
mi
from 43215
Colorado Springs, CO
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Synergy Research Site
Colorado Springs, Colorado 80907
1162
mi
from 43215
Colorado Springs, CO
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Synergy Research Site
Columbia, South Carolina 29203
418
mi
from 43215
Columbia, SC
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Synergy Research Site
Corona, California 92879
1941
mi
from 43215
Corona, CA
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Synergy Research Site
Cutler Bay, Florida 33189
1006
mi
from 43215
Cutler Bay, FL
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Synergy Research Site
Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Synergy Research Site
Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Synergy Research Site
Decatur, Georgia 30032
435
mi
from 43215
Decatur, GA
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Synergy Research Site
Decatur, Georgia 30032
435
mi
from 43215
Decatur, GA
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Synergy Research Site
DeLand, Florida 32720
761
mi
from 43215
DeLand, FL
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Synergy Research Site
Denver, Colorado 80220
1158
mi
from 43215
Denver, CO
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Synergy Research Site
Denver, Colorado 80220
1158
mi
from 43215
Denver, CO
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Synergy Research Site
Denver, Colorado 80220
1158
mi
from 43215
Denver, CO
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Synergy Research Site
Dothan, Alabama 36305
620
mi
from 43215
Dothan, AL
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Synergy Research Site
Elizabeth, New Jersey 07202
466
mi
from 43215
Elizabeth, NJ
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Synergy Research Site
Encinitas, California 92024
1949
mi
from 43215
Encinitas, CA
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Synergy Research Site
Fargo, North Dakota 58103
838
mi
from 43215
Fargo, ND
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Synergy Research Site
Flint, Michigan 48504
216
mi
from 43215
Flint, MI
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Synergy Research Site
Fort Lauderdale, Florida 33306
968
mi
from 43215
Fort Lauderdale, FL
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Synergy Research Site
Fountain Valley, California 92708
1966
mi
from 43215
Fountain Valley, CA
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Synergy Research Site
Franklin, Tennessee 37064
348
mi
from 43215
Franklin, TN
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Synergy Research Site
Fresno, California 93726
1987
mi
from 43215
Fresno, CA
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Synergy Research Site
Grand Island, Nebraska 68803
834
mi
from 43215
Grand Island, NE
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Synergy Research Site
Great Neck, New York 11023
492
mi
from 43215
Great Neck, NY
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Synergy Research Site
Greensboro, North Carolina 27403
320
mi
from 43215
Greensboro, NC
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Synergy Research Site
Gulf Shores, Alabama 36542
721
mi
from 43215
Gulf Shores, AL
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Synergy Research Site
Hawaiian Gardens, California 90716
1969
mi
from 43215
Hawaiian Gardens, CA
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Synergy Research Site
Henderson, Nevada 89014
1754
mi
from 43215
Henderson, NV
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Synergy Research Site
Henrico, Virginia 23233
331
mi
from 43215
Henrico, VA
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Synergy Research Site
Hialeah, Florida 33012
986
mi
from 43215
Hialeah, FL
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Synergy Research Site
Hialeah, Florida 33012
986
mi
from 43215
Hialeah, FL
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Synergy Research Site
Hialeah, Florida 33012
986
mi
from 43215
Hialeah, FL
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Synergy Research Site
Homestead, Florida 33030
1012
mi
from 43215
Homestead, FL
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Synergy Research Site
Houston, Texas 77081
998
mi
from 43215
Houston, TX
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Synergy Research Site
Houston, Texas 77081
998
mi
from 43215
Houston, TX
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Synergy Research Site
Houston, Texas 77081
998
mi
from 43215
Houston, TX
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Synergy Research Site
Houston, Texas 77081
998
mi
from 43215
Houston, TX
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Synergy Research Site
Houston, Texas 77081
998
mi
from 43215
Houston, TX
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Synergy Research Site
Houston, Texas 77081
998
mi
from 43215
Houston, TX
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Synergy Research Site
Huber Heights, Ohio 45424
58
mi
from 43215
Huber Heights, OH
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Synergy Research Site
Humble, Texas 77338
974
mi
from 43215
Humble, TX
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Synergy Research Site
Huntsville, Alabama 35801
409
mi
from 43215
Huntsville, AL
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Synergy Research Site
Jackson, Mississippi 39202
661
mi
from 43215
Jackson, MS
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Synergy Research Site
Jackson, Tennessee 38305
436
mi
from 43215
Jackson, TN
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Synergy Research Site
Jupiter, Florida 33458
915
mi
from 43215
Jupiter, FL
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Synergy Research Site
Katy, Texas 77450
1007
mi
from 43215
Katy, TX
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Synergy Research Site
Kelowna, British Columbia
1888
mi
from 43215
Kelowna,
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Synergy Research Site
Kinston, North Carolina 28501
440
mi
from 43215
Kinston, NC
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Synergy Research Site
Knoxville, Tennessee 37912
278
mi
from 43215
Knoxville, TN
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Synergy Research Site
La Mirada, California 90638
1963
mi
from 43215
La Mirada, CA
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Synergy Research Site
Laguna Hills, California 92653
1955
mi
from 43215
Laguna Hills, CA
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Synergy Research Site
Lakeland, Florida 33805
822
mi
from 43215
Lakeland, FL
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Synergy Research Site
Lancaster, California 93534
1950
mi
from 43215
Lancaster, CA
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Synergy Research Site
Las Vegas, Nevada 89102
1759
mi
from 43215
Las Vegas, NV
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Synergy Research Site
Las Vegas, Nevada 89102
1759
mi
from 43215
Las Vegas, NV
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Synergy Research Site
Las Vegas, Nevada 89102
1759
mi
from 43215
Las Vegas, NV
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