Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)



Status:Recruiting
Conditions:Constipation, Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2015

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

A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation

The objectives of this study are to evaluate the safety, efficacy, and dose response of two
delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2
is DR2) administered orally to patients with irritable bowel syndrome with constipation
(IBS-C). Additional objectives include understanding how the two DR formulations compare
with each other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR]
formulation of linaclotide).


Inclusion Criteria:

- Patient has completed a colonoscopy according to the AGA criteria, with no clinically
significant findings

- Patient has no clinically significant findings on a physical examination and clinical
laboratory tests

- Patient meets protocol criteria for diagnosis of IBS-C

- Patient demonstrates continued IBS-C through Pretreatment Period

- Patient maintains a minimum level of compliance with daily diary

Exclusion Criteria:

- Patient has history of loose or watery stools

- Patient has symptoms of or been diagnosed with a medical condition that may
contribute to abdominal pain

- 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 could confound the study assessments
We found this trial at
74
sites
Waterbury, Connecticut 06708
Phone: 203-419-4420
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
Anaheim, California 92801
Phone: 714-774-7777
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Arlington, Texas 76012
Phone: 972-907-1333
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Atlanta, Georgia 30328
Phone: 404-459-6699
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Baltimore, Maryland 21215
Phone: 410-601-8255
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bastrop, Louisiana 71220
Phone: 318-807-0819
?
mi
from
Bastrop, LA
Click here to add this to my saved trials
Beaumont, Texas 77701
Phone: 409-832-4140
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
Boston, Massachusetts 02131
Phone: 617-477-4868
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bozeman, Montana 59718
Phone: 406-585-2444
?
mi
from
Bozeman, MT
Click here to add this to my saved trials
Bristol, Connecticut 06010
Phone: 860-585-3838
?
mi
from
Bristol, CT
Click here to add this to my saved trials
Bristol, Tennessee 37620
Phone: 423-989-3105
?
mi
from
Bristol, TN
Click here to add this to my saved trials
Brooklyn, New York 11206
Phone: 718-381-2217
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Charlotte, North Carolina 28210
Phone: 704-527-6672
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
Phone: 423-698-4584
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chesterfield, Michigan 48047
Phone: 586-598-3329
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
Phone: 301-652-5520
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
Christiansburg, Virginia 24073
Phone: 540-381-3086
?
mi
from
Christiansburg, VA
Click here to add this to my saved trials
Chula Vista, California 91910
Phone: 619-585-8881
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Cincinnati, Ohio 45219
Phone: 513-681-0606
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80904
Phone: 719-633-1477
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Concord, North Carolina 28025
Phone: 704-527-6672
?
mi
from
Concord, NC
Click here to add this to my saved trials
Dakota Dunes, South Dakota 57049
Phone: 605-232-9000
?
mi
from
Dakota Dunes, SD
Click here to add this to my saved trials
Davidson, North Carolina 28036
Phone: 704-366-3001
?
mi
from
Davidson, NC
Click here to add this to my saved trials
El Paso, Texas 79905
Phone: 915-215-5205
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Evansville, Indiana 47714
Phone: 812-477-2760
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
Phone: 910-484-8163
?
mi
from
Fayetteville, NC
Click here to add this to my saved trials
Garden Grove, California 92843
Phone: 714-554-8080
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Hialeah, Florida 33016
Phone: 305-822-4107
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 77015
Phone: 281-216-3658
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35801
Phone: 256-536-6600
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Jackson, Mississippi 39202
Phone: 601-863-0395
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Kissimmee, Florida 34741
Phone: 844-245-7720
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
Knoxville, Tennessee 37919
Phone: 865-200-8364
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
La Crosse, Wisconsin 54601
Phone: 608-785-5104
?
mi
from
La Crosse, WI
Click here to add this to my saved trials
La Mesa, California 91942
Phone: 619-589-4100
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89119
Phone: 702-570-6107
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89119
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lynchburg, Virginia 24502
Phone: 434-384-1862
?
mi
from
Lynchburg, VA
Click here to add this to my saved trials
Mentor, Ohio 44060
Phone: 440-205-1225
?
mi
from
Mentor, OH
Click here to add this to my saved trials
Metairie, Louisiana 70006
Phone: 504-455-1310
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Miami, Florida 33122
Phone: 305-226-3933
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33122
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33122
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33122
?
mi
from
Miami, FL
Click here to add this to my saved trials
Newport Beach, California 92660
Phone: 310-780-2155
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
North Little Rock, Arkansas 72117
Phone: 501-945-9300
?
mi
from
North Little Rock, AR
Click here to add this to my saved trials
Oakwood, Georgia 30566
Phone: 770-595-1580
?
mi
from
Oakwood, GA
Click here to add this to my saved trials
Ogden, Utah 84405
Phone: 801-409-2040
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Orange, California 92868
Phone: 714-835-1870
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orlando, Florida 32806
Phone: 407-426-9299
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Pheonix, Arizona 85018
Phone: 602-788-3437
?
mi
from
Pheonix, AZ
Click here to add this to my saved trials
Pittsburg, Pennsylvania 15206
Phone: 412-313-1900
?
mi
from
Pittsburg, PA
Click here to add this to my saved trials
Saint Louis, Missouri 63128
Phone: 314-543-5225
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78209
Phone: 210-764-4842
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78209
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78209
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92108
Phone: 619-521-2830
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Sandy, Utah 84094
Phone: 801-409-0240
?
mi
from
Sandy, UT
Click here to add this to my saved trials
Sandy Springs, Georgia 30328
Phone: 404-843-4410
?
mi
from
Sandy Springs, GA
Click here to add this to my saved trials
Shreveport, Louisiana 71105
Phone: 318-525-3226
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
South Miami, Florida 33143
Phone: 305-665-4818
?
mi
from
South Miami, FL
Click here to add this to my saved trials
Tampa, Florida 33607
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Thousand Oaks, California 91360
Phone: 805-496-3322
?
mi
from
Thousand Oaks, CA
Click here to add this to my saved trials
Tucson, Arizona 85710
Phone: 520-546-4700
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tucson, Arizona 85710
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Watertown, Massachusetts 02472
Phone: 617-744-1310
?
mi
from
Watertown, MA
Click here to add this to my saved trials
West Palm Beach, Florida 33409
Phone: 561-689-0606
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Wilmington, North Carolina 28401
Phone: 910-799-5500
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
Winston Salem, North Carolina 27103
Phone: 336-354-1076
?
mi
from
Winston Salem, NC
Click here to add this to my saved trials
Winston Salem, North Carolina 27103
?
mi
from
Winston Salem, NC
Click here to add this to my saved trials
Winston Salem, North Carolina 27103
?
mi
from
Winston Salem, NC
Click here to add this to my saved trials
Wyoming, Michigan 49519
Phone: 616-261-4739
?
mi
from
Wyoming, MI
Click here to add this to my saved trials
Xenia, Ohio 45385
Phone: 937-912-4444
?
mi
from
Xenia, OH
Click here to add this to my saved trials