12-Week Study of Plecanatide for CIC (The CIC3 Study)



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:3/23/2019
Start Date:November 2013
End Date:June 2015

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A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation (The CIC3 Study)

The purpose of this study is to confirm that the investigational medication, plecanatide, is
safe and effective in treating chronic idiopathic constipation.

This is a randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350
adult male and female patients with CIC comparing 2 doses of plecanatide to placebo. The
study will be conducted at approximately 180 clinical study sites in the United States (US)
and Canada. The primary objective of the study is to evaluate the efficacy and safety of 3.0
and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of
patients with CIC. The study population will include only patients without other causes of
constipation or other chronic conditions that could interfere with study assessments.
Patients may not take laxatives (with the exception of the study-provided rescue medication,
bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation
or diarrhea, during study participation.

There are 6 scheduled study visits, including the screening and follow-up visits. The planned
duration of participation in this study will be 112 days and up to 155 days, with washout and
all visit windows considered.

Inclusion Criteria:

- Male or female aged 18-80, inclusive

- Meets modified Rome III criteria for functional chronic idiopathic constipation for at
least 3 months with symptom onset for at least 6 months

- Completed a colonoscopy in accordance with AGA colon cancer screening guidelines (5
years), with no clinically significant findings

- Willing to maintain a stable diet during the study

Exclusion Criteria:

- Loose stool (mushy) or watery (Bristol score 6 or 7) stool in the absence of any
laxative or prohibited medicine for > 25% of BMs during the 3 months prior to
screening visit OR during the 14 day pre-treatment assessment

- Active peptic ulcer disease, diabetes or hypertension not adequately treated or not
stable

- History of cathartic colon, laxative, enema abuse, or ischemic colitis

- Fecal impaction within 3 months of screening

- Patient has had /has any: diseases or conditions associated with constipation (GI or
CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor
dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal
fissures or any disease or condition that can affect GI motility or defecation or can
be associated with abdominal pain

- Unexplained and clinically significant "alarm symptoms" including lower GI bleeding,
iron-deficiency anemia, weight loss or systemic signs of infection or colitis

- Major surgery, stroke or MI within 60 days of screening

- Participated in a previous plecanatide clinical trial
We found this trial at
172
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Southfield, Michigan 48034
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Albuquerque, New Mexico 87108
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Anaheim, California 92801
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Anderson, South Carolina 29621
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Athens, Georgia 30606
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Augusta, Georgia 30912
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Augusta, Kansas 67010
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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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Boston, Massachusetts 02131
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Boynton Beach, Florida 33426
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Bristol, Connecticut 06010
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Brockton, Massachusetts 02302
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Brooklyn, New York 11206
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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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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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Christiansburg, Virginia 24073
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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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Clive, Iowa 50325
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Colorado Springs, Colorado 80907
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Columbia, South Carolina 29203
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Danbury, Connecticut 06810
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Decatur, Georgia 30032
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Encinitas, California 92024
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Encino, California 91436
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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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Fort Lauderdale, Florida 33306
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Fountain Valley, California 92708
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Fresno, California 93726
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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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Henrico, Virginia 23233
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Hilliard, Ohio 43026
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Hot Springs, Arkansas 71913
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Huber Heights, Ohio 45424
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Huntsville, Alabama 35801
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Jackson, Mississippi 39202
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Johns Creek, Georgia 30097
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Killeen, Texas 76543
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Kinston, North Carolina 28501
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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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Lebanon, New Hampshire 03756
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Lexington, Kentucky 40503
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Limerick, Pennsylvania 19468
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Little Rock, Arkansas 72211
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Marrero, Louisiana 70072
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