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

Use our guide to learn which trials are right for you!

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
Corona, California 92879
29
mi
from 91732
Corona, CA
Click here to add this to my saved trials
Synergy Research Site
Albuquerque, New Mexico 87108
653
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
Synergy Research Site
Albuquerque, New Mexico 87108
653
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
Synergy Research Site
Anaheim, California 92801
16
mi
from 91732
Anaheim, CA
Click here to add this to my saved trials
Synergy Research Site
Anaheim, California 92801
16
mi
from 91732
Anaheim, CA
Click here to add this to my saved trials
Synergy Research Site
Anderson, South Carolina 29621
2008
mi
from 91732
Anderson, SC
Click here to add this to my saved trials
Synergy Research Site
Artesia, California 90701
14
mi
from 91732
Artesia, CA
Click here to add this to my saved trials
Synergy Research Site
Athens, Georgia 30606
1970
mi
from 91732
Athens, GA
Click here to add this to my saved trials
Synergy Research Site
Atlanta, Georgia 30312
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
Synergy Research Site
Augusta, Kansas 67010
1201
mi
from 91732
Augusta, KS
Click here to add this to my saved trials
Synergy Research Site
Austin, Texas 78745
1210
mi
from 91732
Austin, TX
Click here to add this to my saved trials
Synergy Research Site
Austin, Texas 78745
1210
mi
from 91732
Austin, TX
Click here to add this to my saved trials
Synergy Research Site
Bastrop, Louisiana 71220
1506
mi
from 91732
Bastrop, LA
Click here to add this to my saved trials
Synergy Research Site
Beavercreek, Ohio 45432
1902
mi
from 91732
Beavercreek, OH
Click here to add this to my saved trials
Synergy Research Site
Biloxi, Mississippi 39531
1710
mi
from 91732
Biloxi, MS
Click here to add this to my saved trials
Synergy Research Site
Birmingham, Alabama 35242
1793
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Synergy Research Site
Blackfoot, Idaho 83221
699
mi
from 91732
Blackfoot, ID
Click here to add this to my saved trials
Synergy Research Site
Boston, Massachusetts 02131
2575
mi
from 91732
Boston, MA
Click here to add this to my saved trials
Synergy Research Site
Boynton Beach, Florida 33426
2307
mi
from 91732
Boynton Beach, FL
Click here to add this to my saved trials
Synergy Research Site
Brandon, Florida 33511
2146
mi
from 91732
Brandon, FL
Click here to add this to my saved trials
Synergy Research Site
Bristol, Connecticut 06010
2483
mi
from 91732
Bristol, CT
Click here to add this to my saved trials
Synergy Research Site
Brooklyn, New York 11206
2436
mi
from 91732
Brooklyn, NY
Click here to add this to my saved trials
Synergy Research Site
Brownsburg, Indiana 46112
1780
mi
from 91732
Brownsburg, IN
Click here to add this to my saved trials
Synergy Research Site
Carlsbad, California 92008
75
mi
from 91732
Carlsbad, CA
Click here to add this to my saved trials
Synergy Research Site
Cary, North Carolina 27518
2211
mi
from 91732
Cary, NC
Click here to add this to my saved trials
Synergy Research Site
Centerville, Ohio 45459
1898
mi
from 91732
Centerville, OH
Click here to add this to my saved trials
Synergy Research Site
Cerritos, California 90703
15
mi
from 91732
Cerritos, CA
Click here to add this to my saved trials
Synergy Research Site
Chandler, Arizona 85224
356
mi
from 91732
Chandler, AZ
Click here to add this to my saved trials
Synergy Research Site
Channelview, Texas 77530
1372
mi
from 91732
Channelview, TX
Click here to add this to my saved trials
Synergy Research Site
Chapel Hill, North Carolina 27599
2194
mi
from 91732
Chapel Hill, NC
Click here to add this to my saved trials
Synergy Research Site
Charleston, South Carolina 29406
2176
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
Synergy Research Site
Charlotte, North Carolina 28210
2101
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Synergy Research Site
Charlotte, North Carolina 28210
2101
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Synergy Research Site
Chattanooga, Tennessee 37421
1862
mi
from 91732
Chattanooga, TN
Click here to add this to my saved trials
Synergy Research Site
Chesterfield, Michigan 48047
1983
mi
from 91732
Chesterfield, MI
Click here to add this to my saved trials
Synergy Research Site
Chevy Chase, Maryland 20815
2278
mi
from 91732
Chevy Chase, MD
Click here to add this to my saved trials
Synergy Research Site
Chicago, Illinois 60602
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
Synergy Research Site
Christiansburg, Virginia 24073
2109
mi
from 91732
Christiansburg, VA
Click here to add this to my saved trials
Synergy Research Site
Chula Vista, California 91910
113
mi
from 91732
Chula Vista, CA
Click here to add this to my saved trials
Synergy Research Site
Cincinnati, Ohio 45246
1882
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Synergy Research Site
Cincinnati, Ohio 45246
1882
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Synergy Research Site
Clearwater, Florida 33759
2122
mi
from 91732
Clearwater, FL
Click here to add this to my saved trials
Synergy Research Site
Clearwater, Florida 33759
2122
mi
from 91732
Clearwater, FL
Click here to add this to my saved trials
Synergy Research Site
Cleveland, Ohio 44122
2041
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
Synergy Research Site
Clive, Iowa 50325
1415
mi
from 91732
Clive, IA
Click here to add this to my saved trials
Synergy Research Site
Colorado Springs, Colorado 80907
804
mi
from 91732
Colorado Springs, CO
Click here to add this to my saved trials
Synergy Research Site
Colorado Springs, Colorado 80907
804
mi
from 91732
Colorado Springs, CO
Click here to add this to my saved trials
Synergy Research Site
Colorado Springs, Colorado 80907
804
mi
from 91732
Colorado Springs, CO
Click here to add this to my saved trials
Synergy Research Site
Columbia, South Carolina 29203
2102
mi
from 91732
Columbia, SC
Click here to add this to my saved trials
Synergy Research Site
Cutler Bay, Florida 33189
2319
mi
from 91732
Cutler Bay, FL
Click here to add this to my saved trials
Synergy Research Site
Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Synergy Research Site
Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Synergy Research Site
Decatur, Georgia 30032
1926
mi
from 91732
Decatur, GA
Click here to add this to my saved trials
Synergy Research Site
Decatur, Georgia 30032
1926
mi
from 91732
Decatur, GA
Click here to add this to my saved trials
Synergy Research Site
DeLand, Florida 32720
2177
mi
from 91732
DeLand, FL
Click here to add this to my saved trials
Synergy Research Site
Denver, Colorado 80220
821
mi
from 91732
Denver, CO
Click here to add this to my saved trials
Synergy Research Site
Denver, Colorado 80220
821
mi
from 91732
Denver, CO
Click here to add this to my saved trials
Synergy Research Site
Denver, Colorado 80220
821
mi
from 91732
Denver, CO
Click here to add this to my saved trials
Synergy Research Site
Dothan, Alabama 36305
1894
mi
from 91732
Dothan, AL
Click here to add this to my saved trials
Synergy Research Site
Elizabeth, New Jersey 07202
2422
mi
from 91732
Elizabeth, NJ
Click here to add this to my saved trials
Synergy Research Site
Encinitas, California 92024
82
mi
from 91732
Encinitas, CA
Click here to add this to my saved trials
Synergy Research Site
Fargo, North Dakota 58103
1413
mi
from 91732
Fargo, ND
Click here to add this to my saved trials
Synergy Research Site
Flint, Michigan 48504
1936
mi
from 91732
Flint, MI
Click here to add this to my saved trials
Synergy Research Site
Fort Lauderdale, Florida 33306
2316
mi
from 91732
Fort Lauderdale, FL
Click here to add this to my saved trials
Synergy Research Site
Fountain Valley, California 92708
25
mi
from 91732
Fountain Valley, CA
Click here to add this to my saved trials
Synergy Research Site
Franklin, Tennessee 37064
1759
mi
from 91732
Franklin, TN
Click here to add this to my saved trials
Synergy Research Site
Fresno, California 93726
212
mi
from 91732
Fresno, CA
Click here to add this to my saved trials
Synergy Research Site
Grand Island, Nebraska 68803
1143
mi
from 91732
Grand Island, NE
Click here to add this to my saved trials
Synergy Research Site
Great Neck, New York 11023
2446
mi
from 91732
Great Neck, NY
Click here to add this to my saved trials
Synergy Research Site
Greensboro, North Carolina 27403
2150
mi
from 91732
Greensboro, NC
Click here to add this to my saved trials
Synergy Research Site
Gulf Shores, Alabama 36542
1785
mi
from 91732
Gulf Shores, AL
Click here to add this to my saved trials
Synergy Research Site
Hawaiian Gardens, California 90716
17
mi
from 91732
Hawaiian Gardens, CA
Click here to add this to my saved trials
Synergy Research Site
Henderson, Nevada 89014
216
mi
from 91732
Henderson, NV
Click here to add this to my saved trials
Synergy Research Site
Henrico, Virginia 23233
2257
mi
from 91732
Henrico, VA
Click here to add this to my saved trials
Synergy Research Site
Hialeah, Florida 33012
2313
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
Synergy Research Site
Hialeah, Florida 33012
2313
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
Synergy Research Site
Hialeah, Florida 33012
2313
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
Synergy Research Site
Homestead, Florida 33030
2314
mi
from 91732
Homestead, FL
Click here to add this to my saved trials
Synergy Research Site
Houston, Texas 77081
1352
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Synergy Research Site
Houston, Texas 77081
1352
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Synergy Research Site
Houston, Texas 77081
1352
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Synergy Research Site
Houston, Texas 77081
1352
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Synergy Research Site
Houston, Texas 77081
1352
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Synergy Research Site
Houston, Texas 77081
1352
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Synergy Research Site
Huber Heights, Ohio 45424
1901
mi
from 91732
Huber Heights, OH
Click here to add this to my saved trials
Synergy Research Site
Humble, Texas 77338
1358
mi
from 91732
Humble, TX
Click here to add this to my saved trials
Synergy Research Site
Huntsville, Alabama 35801
1786
mi
from 91732
Huntsville, AL
Click here to add this to my saved trials
Synergy Research Site
Jackson, Mississippi 39202
1609
mi
from 91732
Jackson, MS
Click here to add this to my saved trials
Synergy Research Site
Jackson, Tennessee 38305
1653
mi
from 91732
Jackson, TN
Click here to add this to my saved trials
Synergy Research Site
Jupiter, Florida 33458
2296
mi
from 91732
Jupiter, FL
Click here to add this to my saved trials
Synergy Research Site
Katy, Texas 77450
1337
mi
from 91732
Katy, TX
Click here to add this to my saved trials
Synergy Research Site
Kelowna, British Columbia
1095
mi
from 91732
Kelowna,
Click here to add this to my saved trials
Synergy Research Site
Kinston, North Carolina 28501
2282
mi
from 91732
Kinston, NC
Click here to add this to my saved trials
Synergy Research Site
Knoxville, Tennessee 37912
1920
mi
from 91732
Knoxville, TN
Click here to add this to my saved trials
Synergy Research Site
La Mirada, California 90638
10
mi
from 91732
La Mirada, CA
Click here to add this to my saved trials
Synergy Research Site
Laguna Hills, California 92653
38
mi
from 91732
Laguna Hills, CA
Click here to add this to my saved trials
Synergy Research Site
Lakeland, Florida 33805
2163
mi
from 91732
Lakeland, FL
Click here to add this to my saved trials
Synergy Research Site
Lancaster, California 93534
43
mi
from 91732
Lancaster, CA
Click here to add this to my saved trials
Synergy Research Site
Las Vegas, Nevada 89102
214
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
Synergy Research Site
Las Vegas, Nevada 89102
214
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
Synergy Research Site
Las Vegas, Nevada 89102
214
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials