A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation



Status:Active, not recruiting
Conditions:Constipation, Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:1/16/2019
Start Date:June 20, 2018
End Date:June 2019

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

A Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide 290 μg Administered Orally for 12 Weeks Followed by a 4-week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation

To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and
abdominal pain) and safety of linaclotide 290 μg administered orally to patients with
irritable bowel syndrome with constipation (IBS-C).

12 week treatment period followed by 4-week Randomized Withdrawal (RW) Period.

Inclusion Criteria:

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

- Female patients of childbearing potential must agree to use one of the following
methods of birth control:

1. Hormonal contraception

2. Double-barrier birth control

3. Maintenance of a monogamous relationship with a male partner who has been
surgically sterilized by vasectomy

- Patient meets protocol criteria for diagnosis of IBS-C

- Patient demonstrates continued IBS-C symptoms 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
78
sites
2510 Lakeland Drive
Flowood, Mississippi 39232
Phone: 601-863-0395
574
mi
from
Flowood, MS
Click here to add this to my saved trials
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Phone: 386-785-0074
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
1123
mi
from
DeLand, FL
Click here to add this to my saved trials
77 West Granada Boulevard
Ormond Beach, Florida 32174
Phone: 386-677-0453
1126
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
571
mi
from
San Antonio, TX
Click here to add this to my saved trials
500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
Phone: 203-721-6040
1338
mi
from
Waterbury, CT
Click here to add this to my saved trials
1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
1282
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Baltimore, Maryland 21215
Phone: 410-601-8255
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
Beaumont, Texas 77702
Phone: 409-832-4140
570
mi
from
Beaumont, TX
Click here to add this to my saved trials
Boston, Massachusetts 02135
Phone: 617-477-4868
1444
mi
from
Boston, MA
Click here to add this to my saved trials
Bozeman, Montana 59718
Phone: 406-585-2444
871
mi
from
Bozeman, MT
Click here to add this to my saved trials
39 Brewster Road
Bristol, Connecticut 06010
Phone: 860-585-3838
1345
mi
from
Bristol, CT
Click here to add this to my saved trials
Brooklyn, New York 11206
Phone: 718-381-2217
1290
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Charlotte, North Carolina 28210
Phone: 704-364-4422
958
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
Phone: 423-698-4584
728
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Christiansburg, Virginia 24073
Phone: 540-381-3086
954
mi
from
Christiansburg, VA
Click here to add this to my saved trials
Chula Vista, California 91910
Phone: 619-585-8882
1140
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Cincinnati, Ohio 45224
Phone: 513-681-0606
724
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45242
Phone: 513-769-2767
734
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Columbus, Ohio 43215
Phone: 614-487-2560
810
mi
from
Columbus, OH
Click here to add this to my saved trials
Concord, North Carolina
Phone: 704-527-6672
968
mi
from
Concord, NC
Click here to add this to my saved trials
801 Monterey Street
Coral Gables, Florida 33134
Phone: 305-445-5637
1318
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Corona, California 92879
Phone: 951-220-4029
1134
mi
from
Corona, CA
Click here to add this to my saved trials
Cumberland, Rhode Island 02864
Phone: 401-439-5502
1424
mi
from
Cumberland, RI
Click here to add this to my saved trials
Dakota Dunes, South Dakota 57049
Phone: 605-232-9000
334
mi
from
Dakota Dunes, SD
Click here to add this to my saved trials
Dayton, Ohio 45415
Phone: 937-320-5050
743
mi
from
Dayton, OH
Click here to add this to my saved trials
Dayton, Ohio 45432
Phone: 937-912-4367
751
mi
from
Dayton, OH
Click here to add this to my saved trials
Encinitas, California 92024
Phone: 760-444-4949
1141
mi
from
Encinitas, CA
Click here to add this to my saved trials
Fargo, North Dakota 58103
Phone: 701-232-7705
631
mi
from
Fargo, ND
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
Phone: 910-484-8163
1063
mi
from
Fayetteville, NC
Click here to add this to my saved trials
Fountain Valley, California 92708
Phone: 714-241-1443
1160
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Garden Grove, California 92840
Phone: 562-860-8059
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Great Neck, New York 11023
Phone: 516-482-5976
1301
mi
from
Great Neck, NY
Click here to add this to my saved trials
Greer, South Carolina 29651
Phone: 864-334-0141
888
mi
from
Greer, SC
Click here to add this to my saved trials
Hagerstown, Maryland 21740
Phone: 301-665-4682
1088
mi
from
Hagerstown, MD
Click here to add this to my saved trials
Hialeah, Florida 33016
Phone: 305-728-4974
1309
mi
from
Hialeah, FL
Click here to add this to my saved trials
HIgh Point, North Carolina 27262
Phone: 336-883-9773
990
mi
from
HIgh Point, NC
Click here to add this to my saved trials
Houston, Texas 77074
Phone: 713-640-5754
569
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35801
Phone: 256-536-6600
660
mi
from
Huntsville, AL
Click here to add this to my saved trials
Inverness, Florida 34452
Phone: 352-341-2100
1084
mi
from
Inverness, FL
Click here to add this to my saved trials
2711 North Orange Blossom Trail
Kissimmee, Florida 34744
Phone: 321-337-0700
1149
mi
from
Kissimmee, FL
Click here to add this to my saved trials
Knoxville, Tennessee 37923
Phone: 865-200-8364
777
mi
from
Knoxville, TN
Click here to add this to my saved trials
La Mesa, California 91942
Phone: 619-589-4100
1133
mi
from
La Mesa, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89121
Phone: 702-570-6107
958
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lynchburg, Virginia 24502
Phone: 434-455-8670
1021
mi
from
Lynchburg, VA
Click here to add this to my saved trials
Mentor, Ohio 44060
Phone: 440-205-1225
915
mi
from
Mentor, OH
Click here to add this to my saved trials
Metairie, Louisiana 70006
Phone: 504-455-1310
690
mi
from
Metairie, LA
Click here to add this to my saved trials
Miami, Florida 33165
Phone: 305-470-8345
1321
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33143
Phone: 305-665-4818
1320
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33175
Phone: 305-226-3933
1321
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida 33014
Phone: 305-424-7420
1309
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Miami Springs, Florida 33166
Phone: 305-885-8983
1315
mi
from
Miami Springs, FL
Click here to add this to my saved trials
Mission Hills, California 91345
Phone: 818-869-7067
1176
mi
from
Mission Hills, CA
Click here to add this to my saved trials
Monroe, Louisiana 71201
Phone: 318-281-6040
484
mi
from
Monroe, LA
Click here to add this to my saved trials
North Hollywood, California 91606
Phone: 818-558-7555
1173
mi
from
North Hollywood, CA
Click here to add this to my saved trials
North Little Rock, Arkansas
Phone: 501-945-9300
371
mi
from
North Little Rock, AR
Click here to add this to my saved trials
Ogden, Utah 84405
Phone: 801-409-2040
789
mi
from
Ogden, UT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
Phone: 405-235-8188
157
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Phoenix, Arizona 85018
Phone: 602-788-3437
846
mi
from
Phoenix, AZ
Click here to add this to my saved trials
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
1064
mi
from
Raleigh, NC
Click here to add this to my saved trials
Saint Louis, Missouri 63128
Phone: 314-543-5225
407
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78209
Phone: 210-824-5678
572
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78258
Phone: 210-764-4842
561
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92115
Phone: 619-501-0371
1143
mi
from
San Diego, CA
Click here to add this to my saved trials
Sandy Springs, Georgia 30328
Phone: 404-843-4410
796
mi
from
Sandy Springs, GA
Click here to add this to my saved trials
Santa Ana, California 92703
Phone: 714-655-5382
1220
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Shreveport, Louisiana 71103
Phone: 619-585-8883
429
mi
from
Shreveport, LA
Click here to add this to my saved trials
Sunrise, Florida 33351
1299
mi
from
Sunrise, FL
Click here to add this to my saved trials
Tampa, Florida 33606
Phone: 813-877-8839
1118
mi
from
Tampa, FL
Click here to add this to my saved trials
Thousand Oaks, California 91360
?
mi
from
Thousand Oaks, CA
Click here to add this to my saved trials
Tucson, Arizona 85712
Phone: 520-318-1236
830
mi
from
Tucson, AZ
Click here to add this to my saved trials
Watertown, Massachusetts 02472
Phone: 617-744-1310
1438
mi
from
Watertown, MA
Click here to add this to my saved trials
1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
Phone: 910-815-6108
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
1135
mi
from
Wilmington, NC
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
Phone: 336-768-3456
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
Phone: 336-397-3703
971
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
Phone: 336-768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
976
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Winter Park, Florida 32792
Phone: 407-543-3461
?
mi
from
Winter Park, FL
Click here to add this to my saved trials
Wyoming, Michigan 49519
Phone: 616-328-5344
730
mi
from
Wyoming, MI
Click here to add this to my saved trials
Yorba Linda, California 92886
Phone: 714-446-5950
?
mi
from
Yorba Linda, CA
Click here to add this to my saved trials