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
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Newport News, Virginia 23606
405
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Newport News, VA
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Albuquerque, New Mexico 87108
1333
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Albuquerque, New Mexico 87106
1333
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Anaheim, California 92801
1960
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Anderson, Indiana 46011
140
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Anderson, IN
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Austin, Texas 78756
1063
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Austin, TX
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Baltimore, Maryland 21236
349
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Baltimore, Maryland 21215
344
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Baton Rouge, Louisiana 70809
802
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Boone, North Carolina 28607
268
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Boston, Massachusetts 02135
643
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Boulder, Colorado 80304
1174
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Boynton Beach, Florida 33426
943
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Brandon, Florida 33511
833
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Bristol, Connecticut 06010
539
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Brooklyn, New York 11206
480
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Brooksville, Florida 34601
788
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Chandler, Arizona 85224
1654
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Chapel Hill, North Carolina 27599
353
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Charlotte, North Carolina 28207
348
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Charlottesville, Virginia 22911
278
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Chattanooga, Tennessee 37421
362
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Chesapeake, Virginia 23320
430
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Chesterfield, Michigan 48047
186
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Chevy Chase, Maryland 20815
323
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Christiansburg, Virginia 24073
241
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Cincinnati, Ohio 45227
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Cincinnati, Ohio 45242
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Cincinnati, Ohio 45249
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Cleveland, Ohio 44122
127
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Clifton, New Jersey 07012
470
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Clive, Iowa 50325
576
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Colorado Springs, Colorado 80909
1161
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Colorado Springs, Colorado 80907
1163
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Colorado Springs, Colorado 80904
1163
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Coral Gables, Florida 33134
995
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Costa Mesa, California 92626
1964
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Dakota Dunes, South Dakota 57049
720
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Dallas, Texas 75231
905
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Dallas, Texas 75234
911
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Davenport, Iowa 52807
409
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Davidson, North Carolina 28036
326
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Dayton, Ohio 45406
65
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Dayton, Ohio 45432
63
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DeLand, Florida 32720
761
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Erie, Pennsylvania 16502
213
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Fayetteville, North Carolina 28304
408
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Fort Worth, Texas 76104
937
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Fremont, Nebraska 68025
712
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Gainesville, Florida 32607
713
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Glendale, Arizona 85308
1665
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Goodyear, Arizona 85395
1677
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Great Neck, New York 11021
492
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Greensboro, North Carolina 27408
321
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Greensboro, North Carolina 27403
321
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Greer, South Carolina 29650
351
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Harrisburg, North Carolina 28075
345
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Hickory, North Carolina 28602
307
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Hickory, North Carolina 28601
304
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High Point, North Carolina 27262
322
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Houston, Texas 77034
991
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Houston, Texas 77094
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Idaho Falls, Idaho 83404
1508
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Inverness, Florida 34452
769
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Iowa City, Iowa 52242
459
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Jackson, Mississippi 39202
662
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Jacksonville, Florida 32224
670
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Katy, Texas 77450
1008
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Kingsport, Tennessee 37660
237
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Kissimmee, Florida 34741
810
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La Crosse, Wisconsin 54601
499
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Las Vegas, Nevada 89102
1759
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Las Vegas, Nevada 89121
1756
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Lauderdale Lakes, Florida 33319
966
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Lenoir, North Carolina 28645
289
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Lexington, Kentucky 40509
154
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Madisonville, Kentucky 42431
302
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Marietta, Georgia 30067
423
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Marietta, Georgia 30060
423
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Marlton, New Jersey 08053
429
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Mentor, Ohio 44060
148
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Metairie, Louisiana 70006
797
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Miami, Florida 33175
996
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Milwaukee, Wisconsin 53215
330
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Monroe, Louisiana 71201
721
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New Smyrna Beach, Florida 32168
765
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Newton, Kansas 67114
779
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Norfolk, Virginia 23502
423
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North Little Rock, Arkansas 72117
621
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Ocala, Florida 34471
747
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Ogden, Utah 84405
1514
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Oklahoma City, Oklahoma 73104
849
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Omaha, Nebraska 68134
682
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Orange, California 92868
1959
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Orlando, Florida 32806
796
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Orlando, Florida 32821
804
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Overland Park, Kansas 66215
624
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Oviedo, Florida 32765
788
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Peoria, Illinois 61602
349
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Phoenix, Arizona 85018
1662
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Phoenix, Arizona 85020
1662
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