The Plecanatide Irritable Bowel Syndrome With Constipation Study (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:December 2014
End Date:February 2017

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A 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 > 35 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
145
sites
Sacramento, California 95831
362
mi
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Sacramento, CA
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Albuquerque, New Mexico 87108
653
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Albuquerque, NM
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Alexandria, Virginia
2281
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Anaheim, California 92801
16
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Arlington, Texas 76012
1205
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Artesia, California 90701
14
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Asheboro, North Carolina
2154
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Athens, Alabama
1762
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Athens, Tennessee
1890
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Atlanta, Georgia 30312
1919
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Augusta, Kansas 67010
1201
mi
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Austin, Texas 78745
1210
mi
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Baltimore, Maryland
2301
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Baton Rouge, Louisiana
1584
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Beavercreek, Ohio 45432
1902
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Bellevue, Washington
960
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Birmingham, Alabama 35242
1793
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Boston, Massachusetts 02131
2575
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Boston, MA
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Bountiful, Utah
578
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Boynton Beach, Florida 33426
2307
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Brandon, Florida 33511
2146
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Bristol, Connecticut 06010
2483
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Brooklyn, New York 11206
2436
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Broomfield, Colorado
818
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Carrollton, Texas
1217
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Cary, North Carolina 27518
2211
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Centennial, Colorado
818
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Chandler, Arizona 85224
356
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Charleston, West Virginia
2036
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Charlotte, North Carolina 28210
2101
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Charlottesville, Virginia
2208
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Chattanooga, Tennessee 37421
1862
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Chesterfield, Michigan 48047
1983
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Chicago, Illinois 60602
1729
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Chula Vista, California 91910
113
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Cincinnati, Ohio 45246
1882
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Cleveland, Ohio 44122
2041
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Columbia, South Carolina 29203
2102
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Concord, North Carolina 28025
2114
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Conway, Arkansas
1452
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Corona, California 92879
29
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Crowley, Louisiana
1519
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Dallas, Texas 75231
1225
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Davidson, North Carolina
2099
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DeLand, Florida 32720
2177
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Dothan, Alabama 36305
1894
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Encino, California 91436
27
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Englewood, Ohio
1891
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Evanston, Illinois
1728
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Evansville, Indiana 47725
1717
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Evergreen Park, Illinois
1624
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Fargo, North Dakota 58103
1413
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Flint, Michigan 48504
1936
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Foley, Alabama
1783
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Fort Lauderdale, Florida 33306
2316
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Fountain Valley, California 92708
25
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Fresno, California 93726
212
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Gaffney, South Carolina
2058
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Garden Grove, California 92843
21
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Glendale, Arizona
336
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Great Neck, New York 11023
2446
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Greensboro, North Carolina 27403
2150
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Greer, South Carolina 29651
2027
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Hagerstown, Maryland
2241
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Hamden, Connecticut
2487
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Hazelwood, Missouri
1564
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Homestead, Florida 33030
2314
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Houston, Texas 77081
1352
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Huntsville, Alabama 35801
1786
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995 University Boulevard
Idaho Falls, Idaho 83401
726
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Inverness, Florida
2123
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Jackson, Mississippi 39202
1609
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Jacksonville, Florida 32256
2138
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Kinston, North Carolina 28501
2282
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La Mesa, California 91945
108
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La Mirada, California 90638
10
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Laguna Hills, California 92653
38
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Lancaster, California 93534
43
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Las Vegas, Nevada 89102
214
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Lenoir, North Carolina
2056
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Levittown, Pennsylvania 19056
2392
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Little Rock, Arkansas 72211
1455
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Lynchburg, Virginia 24502
2173
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Mandeville, Louisiana
1648
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Marietta, Georgia
1907
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Marlton, New Jersey 08053
2388
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Memphis, Tennessee 38119
1586
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Metairie, Louisiana 70006
1647
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Miami, Florida 33173
2314
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Miami Lakes, Florida 33016
2311
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Milwaukee, Wisconsin
1729
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Monroe, Louisiana
1495
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Montgomery, Alabama
1829
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Morgantown, West Virginia
2122
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Nashville, Tennessee 37205
1758
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New Orleans, Louisiana 70115
1654
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New Windsor, New York
2429
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New York, New York 10016
2434
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Newport News, Virginia 23606
2328
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Newton, Kansas 67114
1183
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Norcross, Georgia
1926
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