Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)



Status:Completed
Conditions:Constipation, Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 85
Updated:10/6/2017
Start Date:June 2015
End Date:February 2017

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Second Phase 3 Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,
parallel-group clinical trial with 12 weeks of study drug therapy.

This study in patients with IBS-C is a randomized, double-blind, placebo-controlled,
parallel-group clinical trial with 12 weeks of study drug therapy.

Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow
for any necessary diagnostic procedures, allow for required washout of medications and to
determine study eligibility. If otherwise eligible based on screening criteria, patients will
undergo a 2-week baseline assessment using an electronic diary where they will record daily
assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS),
abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary
assessment just prior to the randomization visit will be used to confirm IBS-C and study
eligibility as well as define the patient's baseline from which change will be determined.

Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three
blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of
study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication
use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will
return to the clinic to undergo safety and efficacy assessments.

Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily
electronic diaries. Patients will then return to the clinical site for a final follow-up
visit during Week 14 following randomization.

The planned duration of participation in this study will be at least 116 days from signing of
informed consent through post-treatment or up to approximately 135 days with visit windows
considered.

Inclusion Criteria:

• Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS
based on ROME III diagnostic criteria and meeting criteria for diagnosis of the
constipation predominant subtype - IBS-C

Exclusion Criteria:

- Refusal or inability to sign informed consent for the trial

- Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day
daily Calls, and/or complete electronic questionnaires

- BMI ≥ 40 or < 18

- Women of child bearing potential who refuse to use an acceptable method of birth
control for the duration of the trial

- Women who are pregnant or lactating

- Diagnosis of IBS-D or IBS-M

- Organic or obstructive disease of the small or large intestine

- Use of laxatives other than the study-supplied rescue medication (Dulcolax®,
bisacodyl)

- Use of a prohibited concomitant medication within the time frame prior to screening
outlined in the study protocol for that medication

- Unstable medical illness

- Bilirubin > 3X ULN in the absence of a conjugation defect

- Any laboratory value > 3X ULN unless discussed and approved by the study Medical
Monitor
We found this trial at
160
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Orangevale, California
364
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Orangevale, CA
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Albuquerque, New Mexico 87108
653
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Anderson, South Carolina 29621
2008
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Annapolis, Maryland
2309
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Atlanta, Georgia 30312
1919
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Atlantis, Florida
2305
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Austin, Texas 78745
1210
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Baytown, Texas
1380
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Beaumont, Texas
1423
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Birmingham, Alabama 35242
1793
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Blackfoot, Idaho 83221
699
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Blackwood, New Jersey 08012
2381
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Blue Island, Illinois
1725
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Boca Raton, Florida
2312
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Boise, Idaho 83709
661
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Bradenton, Florida 34208
2140
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Brandon, Florida 33511
2146
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Brooksville, Florida 34601
2126
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Brownsburg, Indiana 46112
1780
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Canoga Park, California
34
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Carmichael, California 95608
364
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Catonsville, Maryland
2295
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Channelview, Texas 77530
1372
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Chapel Hill, North Carolina 27599
2194
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Chesapeake, Virginia
2341
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Chesterfield, Missouri
1552
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Chicago, Illinois 60602
1729
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Chino, California
19
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Chula Vista, California 91910
113
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Cincinnati, Ohio 45246
1882
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Clearwater, Florida 33759
2122
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Colorado Springs, Colorado 80907
804
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Columbus, Ohio 43214
1960
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Conway, Arkansas
1452
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Cutler Bay, Florida 33189
2319
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Dallas, Texas 75231
1225
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Dayton, Ohio 45424
1897
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Decatur, Georgia 30032
1926
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Denver, Colorado 80220
821
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Doylestown, Pennsylvania
2375
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Egg Harbor City, New Jersey
2405
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El Cajon, California
107
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Encino, California 91436
27
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Evanston, Illinois
1728
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Fairfax, Virginia
2267
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Fayetteville, North Carolina
2213
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Fayetteville, Tennessee
1782
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Foothill Ranch, California
44
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Fort Lauderdale, Florida 33306
2316
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Franklin, Ohio
1891
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Franklin, Tennessee 37064
1759
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Garden Grove, California 92843
21
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Glendale, Arizona
336
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Greer, South Carolina 29651
2027
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Guntersville, Alabama
1804
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Hamden, Connecticut
2487
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Hermitage, Tennessee
1772
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Hialeah, Florida 33012
2313
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High Point, North Carolina 27262
1997
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Hoffman Estates, Illinois
1708
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Hopewell Junction, New York
2439
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Houston, Texas 77081
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Humble, Texas 77338
1358
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7451 Warner Avenue
Huntington Beach, California 92647
24
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Huntsville, Alabama 35801
1786
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Indianapolis, Indiana
1792
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Irvine, California
29
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Jackson, Tennessee 38305
1653
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Jacksonville, Florida 32256
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Kalamazoo, Michigan
1837
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Kettering, Ohio 45429
1898
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Kew Gardens, New York
2441
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Kingsport, Tennessee 37660
1994
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Kingwood, West Virginia
2137
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Knoxville, Tennessee 37912
1920
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La Crosse, Wisconsin
1578
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Lampasas, Texas
1171
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Lansdale, Pennsylvania
2367
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Las Vegas, Nevada 89102
214
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Lauderdale Lakes, Florida
2310
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Levittown, Pennsylvania 19056
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Lilburn, Georgia
1931
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Little Rock, Arkansas 72211
1455
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25
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Long Beach, California 90806
21
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Los Angeles, California 90015
14
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Madisonville, Kentucky 42431
1719
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Maitland, Florida 32751
2183
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Marietta, Georgia
1907
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Marlborough, Massachusetts
2553
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Marrero, Louisiana 70072
1655
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McKinney, Texas
1230
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Mentor, Ohio 44060
2051
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Meridian, Idaho
664
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Miami, Florida 33173
2314
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Miami Lakes, Florida 33016
2311
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Miami Springs, Florida 33166
2315
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Middleburg Heights, Ohio 44130
2025
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Mission Hills, California 91345
28
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Missoula, Montana
908
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