Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)



Status:Completed
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:10/3/2018
Start Date:February 2016
End Date:September 19, 2018

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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis

The purpose of this trial is to investigate the safety and efficacy of mesalamine 2 g
extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic
remission in subjects with UC. The duration of treatment for each subject will be 6 months.


Inclusion Criteria:

- Male or female subjects aged 18 to 75 years, with Ulcerative Colitis in remission

Exclusion Criteria:

- Evidence of other forms of inflammatory bowel disease

- Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus
[HBV], or hepatitis C virus [HCV])

- Disease limited to proctitis <15 cm

- Short bowel syndrome

- Prior colon resection surgery

- History of severe/fulminant UC

- Intolerant or allergic to aspirin or salicylate derivatives

- Use of rectal formulations (5-aminosalicylic acid [5-ASA], steroids) within ≤7 days

- Women who are pregnant or nursing

- History of known malignancy

- History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune
diseases, or mental/ emotional disorders, that would interfere with their
participation in the trial
We found this trial at
19
sites
19255 Park Row Drive
Houston, Texas 77084
?
mi
from
Houston, TX
Click here to add this to my saved trials
Christiansburg, Virginia 24073
?
mi
from
Christiansburg, VA
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
?
mi
from
Fayetteville, NC
Click here to add this to my saved trials
?
mi
from
Hermitage, TN
Click here to add this to my saved trials
Houston, Texas 77084
?
mi
from
Houston, TX
Click here to add this to my saved trials
1 Lakeshore Drive
Lake Charles, Louisiana 70601
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Little Rock, Arkansas 72211
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
6141 Sunset Drive
Miami, Florida 33143
?
mi
from
Miami, FL
Click here to add this to my saved trials
39250 Murrieta Hot Springs Road
Murrieta, California 92563
?
mi
from
Murrieta, CA
Click here to add this to my saved trials
Nashville, Tennessee 37211
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Ogden, Utah 84405
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Palmetto Bay, Florida
?
mi
from
Palmetto Bay, FL
Click here to add this to my saved trials
Pasadena, Texas 77504
?
mi
from
Pasadena, TX
Click here to add this to my saved trials
9050 Pines Boulevard
Pembroke Pines, Florida 33024
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
?
mi
from
Pleven,
Click here to add this to my saved trials
Sweetwater, Florida 33172
?
mi
from
Sweetwater, FL
Click here to add this to my saved trials
Tomball, Texas 77375
?
mi
from
Tomball, TX
Click here to add this to my saved trials
Wilmington, North Carolina 28403
?
mi
from
Wilmington, NC
Click here to add this to my saved trials