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
Chapel Hill, North Carolina 27599
2194
mi
from 91732
Chapel Hill, NC
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Albuquerque, New Mexico 87108
649
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Albuquerque, NM
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Albuquerque, New Mexico 87106
649
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Albuquerque, NM
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Anaheim, California 92801
17
mi
from 91732
Anaheim, CA
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Anderson, Indiana 46011
1819
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Anderson, IN
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Austin, Texas 78756
1211
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from 91732
Austin, TX
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Baltimore, Maryland 21236
2308
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Baltimore, MD
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Baltimore, Maryland 21215
2301
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Baltimore, MD
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Baton Rouge, Louisiana 70809
1582
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from 91732
Baton Rouge, LA
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Boone, North Carolina 28607
2045
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Boone, NC
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Boston, Massachusetts 02135
2578
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Boston, MA
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Boulder, Colorado 80304
812
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Boulder, CO
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Boynton Beach, Florida 33426
2309
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Boynton Beach, FL
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Brandon, Florida 33511
2146
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Brandon, FL
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Bristol, Connecticut 06010
2484
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Bristol, CT
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Brooklyn, New York 11206
2436
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Brooklyn, NY
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Brooksville, Florida 34601
2126
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Brooksville, FL
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Chandler, Arizona 85224
358
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Chandler, AZ
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Charlotte, North Carolina 28207
2102
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Charlotte, NC
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Charlottesville, Virginia 22911
2208
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Charlottesville, VA
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Chattanooga, Tennessee 37421
1853
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Chattanooga, TN
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Chesapeake, Virginia 23320
2340
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Chesapeake, VA
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Chesterfield, Michigan 48047
1979
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Chesterfield, MI
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Chevy Chase, Maryland 20815
2278
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Chevy Chase, MD
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Christiansburg, Virginia 24073
2109
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Christiansburg, VA
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Cincinnati, Ohio 45227
1886
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Cincinnati, OH
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Cincinnati, Ohio 45242
1880
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Cincinnati, OH
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Cincinnati, Ohio 45249
1880
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Cincinnati, OH
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Cleveland, Ohio 44122
2032
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Clifton, New Jersey 07012
2424
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Clive, Iowa 50325
1412
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Clive, IA
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Colorado Springs, Colorado 80909
805
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Colorado Springs, Colorado 80907
802
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Colorado Springs, CO
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Colorado Springs, Colorado 80904
802
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Coral Gables, Florida 33134
2318
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Coral Gables, FL
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Costa Mesa, California 92626
28
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Costa Mesa, CA
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Dakota Dunes, South Dakota 57049
1299
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Dallas, Texas 75231
1226
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Dallas, Texas 75234
1224
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Davenport, Iowa 52807
1576
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Davidson, North Carolina 28036
2128
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Dayton, Ohio 45406
1894
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Dayton, OH
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Dayton, Ohio 45432
1897
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Dayton, OH
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DeLand, Florida 32720
2177
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Erie, Pennsylvania 16502
2117
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Erie, PA
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Fayetteville, North Carolina 28304
2213
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Fayetteville, NC
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Fort Worth, Texas 76104
1194
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Fremont, Nebraska 68025
1276
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Gainesville, Florida 32607
2101
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Glendale, Arizona 85308
336
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Goodyear, Arizona 85395
327
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Goodyear, AZ
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Great Neck, New York 11021
2446
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Greensboro, North Carolina 27408
2151
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Greensboro, North Carolina 27403
2151
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Greer, South Carolina 29650
2029
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Harrisburg, North Carolina 28075
2110
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Hickory, North Carolina 28602
2068
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Hickory, North Carolina 28601
2069
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High Point, North Carolina 27262
2141
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Houston, Texas 77034
1357
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Houston, Texas 77094
1357
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Idaho Falls, Idaho 83404
725
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Inverness, Florida 34452
2123
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Iowa City, Iowa 52242
1529
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Iowa City, IA
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Jackson, Mississippi 39202
1609
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Jackson, MS
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Jacksonville, Florida 32224
2130
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Katy, Texas 77450
1330
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Kingsport, Tennessee 37660
1994
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Kissimmee, Florida 34741
2187
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La Crosse, Wisconsin 54601
1578
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Las Vegas, Nevada 89102
214
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Las Vegas, Nevada 89121
217
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Lauderdale Lakes, Florida 33319
2310
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Lauderdale Lakes, FL
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Lenoir, North Carolina 28645
2055
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Lenoir, NC
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Lexington, Kentucky 40509
1881
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Lexington, KY
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Madisonville, Kentucky 42431
1718
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Marietta, Georgia 30067
1907
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Marietta, Georgia 30060
1907
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Marlton, New Jersey 08053
2388
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Mentor, Ohio 44060
2051
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Metairie, Louisiana 70006
1652
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Miami, Florida 33175
2320
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Milwaukee, Wisconsin 53215
1729
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Monroe, Louisiana 71201
1495
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New Smyrna Beach, Florida 32168
2199
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Newport News, Virginia 23606
2324
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Newton, Kansas 67114
1183
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Newton, KS
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Norfolk, Virginia 23502
2337
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North Little Rock, Arkansas 72117
1464
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Ocala, Florida 34471
2128
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Ogden, Utah 84405
594
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Ogden, UT
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Oklahoma City, Oklahoma 73104
1164
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Oklahoma City, OK
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Omaha, Nebraska 68134
1300
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Orange, California 92868
21
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Orange, CA
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Orlando, Florida 32806
2185
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Orlando, FL
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Orlando, Florida 32821
2182
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Orlando, FL
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Overland Park, Kansas 66215
1335
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Overland Park, KS
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Oviedo, Florida 32765
2191
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Oviedo, FL
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Peoria, Illinois 61602
1618
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Peoria, IL
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Phoenix, Arizona 85018
343
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Phoenix, Arizona 85020
343
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Phoenix, AZ
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