Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:August 2012
End Date:September 2013
Contact:Sandra Beaird, PhD
Email:info@forestpharm.com
Phone:1-800-678-1605

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Phase 3b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Chronic Constipation and Prominent Abdominal Bloating at Baseline


The purpose of this study is to evaluate the efficacy and safety of linaclotide compared
with placebo in patients with chronic constipation (CC) and prominent abdominal bloating.
This study includes an up to 3-week screening period and a 2-3 week pretreatment period.
Patients who are eligible will be randomized to one of two doses of linaclotide or placebo
for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement
frequency, as well as other abdominal and bowel symptoms of CC.


Inclusion Criteria:

- Patient has completed a colonoscopy according to the American Gastroenterological
Association criteria with no clinically significant findings

- Patient has successfully completed protocol procedures (with no clinically
significant findings)

- Patient meets protocol criteria for Chronic Constipation(CC): < 3 bowel movements per
week and reports one or more of the following symptoms for at least 12 weeks:

1. Straining during more than 25% of BMs

2. Lumpy or hard stools during more than 25% of BMs

3. Sensation of incomplete evacuation during more than 25% of BMs

- Patient demonstrates continued chronic constipation and bloating through Pretreatment
Period

- Patient is compliant with Interactive voice response System (IVRS)

Exclusion Criteria:

- Patient has a history of loose or watery stools

- Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)

- Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
or condition that can affect GI motility

- Patient has any protocol-excluded or clinically significant medical or surgical
history that would limit the patient's ability to complete or participate in this
clinical trial or could confound the study assessments
We found this trial at
140
sites
Great Neck, New York 11021
334
mi
from 16510
Great Neck, NY
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Albuquerque, New Mexico 87108
1513
mi
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Albuquerque, NM
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Albuquerque, New Mexico 87106
1513
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Albuquerque, NM
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Anaheim, California 92801
2126
mi
from 16510
Anaheim, CA
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Anderson, Indiana 46011
328
mi
from 16510
Anderson, IN
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Austin, Texas 78756
1278
mi
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Austin, TX
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Baltimore, Maryland 21236
261
mi
from 16510
Baltimore, MD
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Baltimore, Maryland 21215
261
mi
from 16510
Baltimore, MD
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Baton Rouge, Louisiana 70809
1018
mi
from 16510
Baton Rouge, LA
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Boone, North Carolina 28607
417
mi
from 16510
Boone, NC
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Boston, Massachusetts 02135
455
mi
from 16510
Boston, MA
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Boulder, Colorado 80304
1322
mi
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Boulder, CO
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Boynton Beach, Florida 33426
1076
mi
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Boynton Beach, FL
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Brandon, Florida 33511
989
mi
from 16510
Brandon, FL
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Bristol, Connecticut 06010
361
mi
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Bristol, CT
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Brooklyn, New York 11206
327
mi
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Brooklyn, NY
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Brooksville, Florida 34601
945
mi
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Brooksville, FL
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Chandler, Arizona 85224
1833
mi
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Chandler, AZ
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Chapel Hill, North Carolina 27599
430
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Chapel Hill, NC
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Charlotte, North Carolina 28207
478
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Charlotte, NC
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Charlottesville, Virginia 22911
292
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Charlottesville, VA
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Chattanooga, Tennessee 37421
566
mi
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Chesapeake, Virginia 23320
421
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Chesapeake, VA
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Chesterfield, Michigan 48047
152
mi
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Chesterfield, MI
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Chevy Chase, Maryland 20815
263
mi
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Chevy Chase, MD
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Christiansburg, Virginia 24073
344
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Cincinnati, Ohio 45227
309
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Cincinnati, OH
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Cincinnati, Ohio 45242
316
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Cincinnati, OH
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Cincinnati, Ohio 45249
316
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Cleveland, Ohio 44122
98
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Cleveland, OH
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Clifton, New Jersey 07012
311
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Clive, Iowa 50325
714
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Clive, IA
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Colorado Springs, Colorado 80909
1319
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Colorado Springs, Colorado 80907
1321
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Colorado Springs, CO
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Colorado Springs, Colorado 80904
1321
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Colorado Springs, CO
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Coral Gables, Florida 33134
1130
mi
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Coral Gables, FL
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Costa Mesa, California 92626
2130
mi
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Costa Mesa, CA
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Dakota Dunes, South Dakota 57049
843
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Dakota Dunes, SD
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Dallas, Texas 75231
1116
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Dallas, TX
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Dallas, Texas 75234
1123
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Dallas, TX
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Davenport, Iowa 52807
547
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Davidson, North Carolina 28036
438
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Davidson, NC
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Dayton, Ohio 45406
275
mi
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Dayton, OH
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Dayton, Ohio 45432
274
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DeLand, Florida 32720
906
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Erie, Pennsylvania 16502
6
mi
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Erie, PA
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Fayetteville, North Carolina 28304
490
mi
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Fort Worth, Texas 76104
1148
mi
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Fort Worth, TX
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Fremont, Nebraska 68025
852
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Gainesville, Florida 32607
871
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Glendale, Arizona 85308
1843
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Goodyear, Arizona 85395
1855
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Greensboro, North Carolina 27408
417
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Greensboro, North Carolina 27403
417
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Greer, South Carolina 29650
511
mi
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Harrisburg, North Carolina 28075
470
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Hickory, North Carolina 28602
448
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Hickory, North Carolina 28601
444
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High Point, North Carolina 27262
425
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Houston, Texas 77034
1209
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Houston, Texas 77094
1209
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Idaho Falls, Idaho 83404
1619
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Inverness, Florida 34452
926
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Iowa City, Iowa 52242
595
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Jackson, Mississippi 39202
879
mi
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Jackson, MS
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Jacksonville, Florida 32224
819
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Katy, Texas 77450
1225
mi
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Katy, TX
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Kingsport, Tennessee 37660
408
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Kissimmee, Florida 34741
957
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La Crosse, Wisconsin 54601
582
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Las Vegas, Nevada 89102
1918
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Las Vegas, NV
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Las Vegas, Nevada 89121
1915
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Las Vegas, NV
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Lauderdale Lakes, Florida 33319
1101
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Lenoir, North Carolina 28645
434
mi
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Lexington, Kentucky 40509
369
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Lexington, KY
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Madisonville, Kentucky 42431
519
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Marietta, Georgia 30067
616
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Marietta, GA
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Marietta, Georgia 30060
616
mi
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Marlton, New Jersey 08053
303
mi
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Mentor, Ohio 44060
76
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Mentor, OH
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Metairie, Louisiana 70006
1010
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Metairie, LA
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Miami, Florida 33175
1131
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Milwaukee, Wisconsin 53215
409
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Monroe, Louisiana 71201
939
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New Smyrna Beach, Florida 32168
905
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Newport News, Virginia 23606
393
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Newport News, VA
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Newton, Kansas 67114
959
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Newton, KS
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Norfolk, Virginia 23502
412
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North Little Rock, Arkansas 72117
836
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North Little Rock, AR
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Ocala, Florida 34471
901
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Ocala, FL
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Ogden, Utah 84405
1643
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Ogden, UT
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Oklahoma City, Oklahoma 73104
1048
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Omaha, Nebraska 68134
825
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Orange, California 92868
2125
mi
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Orlando, Florida 32806
942
mi
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Orlando, FL
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Orlando, Florida 32821
951
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Orlando, FL
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Overland Park, Kansas 66215
801
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Overland Park, KS
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Oviedo, Florida 32765
932
mi
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Oviedo, FL
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Peoria, Illinois 61602
508
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Peoria, IL
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Phoenix, Arizona 85018
1840
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Phoenix, AZ
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Phoenix, Arizona 85020
1840
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Phoenix, AZ
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