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

Use our guide to learn which trials are right for you!

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
La Crosse, Wisconsin 54601
541
mi
from
La Crosse, WI
Click here to add this to my saved trials
Albuquerque, New Mexico 87108
523
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Albuquerque, New Mexico 87106
523
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Anaheim, California 92801
1155
mi
from
Anaheim, CA
Click here to add this to my saved trials
Anderson, Indiana 46011
671
mi
from
Anderson, IN
Click here to add this to my saved trials
Austin, Texas 78756
513
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21236
1155
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21215
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
631
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Boone, North Carolina 28607
895
mi
from
Boone, NC
Click here to add this to my saved trials
Boston, Massachusetts 02135
1444
mi
from
Boston, MA
Click here to add this to my saved trials
Boulder, Colorado 80304
430
mi
from
Boulder, CO
Click here to add this to my saved trials
Boynton Beach, Florida 33426
1292
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Brandon, Florida 33511
1126
mi
from
Brandon, FL
Click here to add this to my saved trials
Bristol, Connecticut 06010
1344
mi
from
Bristol, CT
Click here to add this to my saved trials
Brooklyn, New York 11206
1290
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Brooksville, Florida 34601
1093
mi
from
Brooksville, FL
Click here to add this to my saved trials
Chandler, Arizona 85224
844
mi
from
Chandler, AZ
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
1043
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
958
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22911
1053
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
719
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chesapeake, Virginia 23320
1186
mi
from
Chesapeake, VA
Click here to add this to my saved trials
Chesterfield, Michigan 48047
858
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
1123
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
Christiansburg, Virginia 24073
954
mi
from
Christiansburg, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45227
732
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45242
726
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45249
726
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44122
895
mi
from
Cleveland, OH
Click here to add this to my saved trials
Clifton, New Jersey 07012
1279
mi
from
Clifton, NJ
Click here to add this to my saved trials
Clive, Iowa 50325
341
mi
from
Clive, IA
Click here to add this to my saved trials
Colorado Springs, Colorado 80909
384
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
386
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Colorado Springs, Colorado 80904
386
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Coral Gables, Florida 33134
1319
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Costa Mesa, California 92626
1158
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
Dakota Dunes, South Dakota 57049
334
mi
from
Dakota Dunes, SD
Click here to add this to my saved trials
Dallas, Texas 75231
342
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75234
348
mi
from
Dallas, TX
Click here to add this to my saved trials
Davenport, Iowa 52807
465
mi
from
Davenport, IA
Click here to add this to my saved trials
Davidson, North Carolina 28036
979
mi
from
Davidson, NC
Click here to add this to my saved trials
Dayton, Ohio 45406
744
mi
from
Dayton, OH
Click here to add this to my saved trials
Dayton, Ohio 45432
746
mi
from
Dayton, OH
Click here to add this to my saved trials
DeLand, Florida 32720
1124
mi
from
DeLand, FL
Click here to add this to my saved trials
Erie, Pennsylvania 16502
984
mi
from
Erie, PA
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
1067
mi
from
Fayetteville, NC
Click here to add this to my saved trials
Fort Worth, Texas 76104
346
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fremont, Nebraska 68025
264
mi
from
Fremont, NE
Click here to add this to my saved trials
Gainesville, Florida 32607
1046
mi
from
Gainesville, FL
Click here to add this to my saved trials
Glendale, Arizona 85308
856
mi
from
Glendale, AZ
Click here to add this to my saved trials
Goodyear, Arizona 85395
868
mi
from
Goodyear, AZ
Click here to add this to my saved trials
Great Neck, New York 11021
1301
mi
from
Great Neck, NY
Click here to add this to my saved trials
Greensboro, North Carolina 27408
1001
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greensboro, North Carolina 27403
1001
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greer, South Carolina 29650
889
mi
from
Greer, SC
Click here to add this to my saved trials
Harrisburg, North Carolina 28075
965
mi
from
Harrisburg, NC
Click here to add this to my saved trials
Hickory, North Carolina 28602
921
mi
from
Hickory, NC
Click here to add this to my saved trials
Hickory, North Carolina 28601
921
mi
from
Hickory, NC
Click here to add this to my saved trials
High Point, North Carolina 27262
991
mi
from
High Point, NC
Click here to add this to my saved trials
Houston, Texas 77034
569
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77094
569
mi
from
Houston, TX
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
843
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Inverness, Florida 34452
1083
mi
from
Inverness, FL
Click here to add this to my saved trials
Iowa City, Iowa 52242
429
mi
from
Iowa City, IA
Click here to add this to my saved trials
Jackson, Mississippi 39202
573
mi
from
Jackson, MS
Click here to add this to my saved trials
Jacksonville, Florida 32224
1055
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Katy, Texas 77450
561
mi
from
Katy, TX
Click here to add this to my saved trials
Kingsport, Tennessee 37660
843
mi
from
Kingsport, TN
Click here to add this to my saved trials
Kissimmee, Florida 34741
1149
mi
from
Kissimmee, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89102
963
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89121
960
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33319
1302
mi
from
Lauderdale Lakes, FL
Click here to add this to my saved trials
Lenoir, North Carolina 28645
907
mi
from
Lenoir, NC
Click here to add this to my saved trials
Lexington, Kentucky 40509
725
mi
from
Lexington, KY
Click here to add this to my saved trials
Madisonville, Kentucky 42431
565
mi
from
Madisonville, KY
Click here to add this to my saved trials
Marietta, Georgia 30067
787
mi
from
Marietta, GA
Click here to add this to my saved trials
Marietta, Georgia 30060
787
mi
from
Marietta, GA
Click here to add this to my saved trials
Marlton, New Jersey 08053
1238
mi
from
Marlton, NJ
Click here to add this to my saved trials
Mentor, Ohio 44060
915
mi
from
Mentor, OH
Click here to add this to my saved trials
Metairie, Louisiana 70006
693
mi
from
Metairie, LA
Click here to add this to my saved trials
Miami, Florida 33175
1321
mi
from
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53215
636
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Monroe, Louisiana 71201
484
mi
from
Monroe, LA
Click here to add this to my saved trials
New Smyrna Beach, Florida 32168
1143
mi
from
New Smyrna Beach, FL
Click here to add this to my saved trials
Newport News, Virginia 23606
1169
mi
from
Newport News, VA
Click here to add this to my saved trials
Newton, Kansas 67114
33
mi
from
Newton, KS
Click here to add this to my saved trials
Norfolk, Virginia 23502
1182
mi
from
Norfolk, VA
Click here to add this to my saved trials
North Little Rock, Arkansas 72117
372
mi
from
North Little Rock, AR
Click here to add this to my saved trials
Ocala, Florida 34471
1080
mi
from
Ocala, FL
Click here to add this to my saved trials
Ogden, Utah 84405
790
mi
from
Ogden, UT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
158
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68134
262
mi
from
Omaha, NE
Click here to add this to my saved trials
Orange, California 92868
1154
mi
from
Orange, CA
Click here to add this to my saved trials
Orlando, Florida 32806
1143
mi
from
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32821
1143
mi
from
Orlando, FL
Click here to add this to my saved trials
Overland Park, Kansas 66215
190
mi
from
Overland Park, KS
Click here to add this to my saved trials
Oviedo, Florida 32765
1145
mi
from
Oviedo, FL
Click here to add this to my saved trials
Peoria, Illinois 61602
485
mi
from
Peoria, IL
Click here to add this to my saved trials
Phoenix, Arizona 85018
853
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85020
853
mi
from
Phoenix, AZ
Click here to add this to my saved trials