Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)



Status:Completed
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/3/2019
Start Date:October 2015
End Date:April 3, 2018

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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis

The purpose of this trial is to investigate the efficacy of mesalamine for the induction of
clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will
receive 4 g extended release granules (sachet) once daily.


Inclusion Criteria:

- Male or female subjects aged 18 to 75 years

- Mild to moderate UC

Exclusion Criteria:

- Disease limited to proctitis <15 cm

- Short bowel syndrome

- Prior colon resection surgery

- History of severe/fulminant UC

- Evidence of other forms of inflammatory bowel disease

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

- 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 or 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
Wilmington, North Carolina 28403
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Wilmington, NC
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Christiansburg, Virginia 24073
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Christiansburg, VA
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Fayetteville, North Carolina 28304
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Fayetteville, NC
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Hermitage, TN
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Houston, Texas 77084
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Houston, TX
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19255 Park Row Drive
Houston, Texas 77084
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Houston, TX
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1 Lakeshore Drive
Lake Charles, Louisiana 70601
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Lake Charles, LA
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Little Rock, Arkansas 72211
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Little Rock, AR
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6141 Sunset Drive
Miami, Florida 33143
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Miami, FL
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39250 Murrieta Hot Springs Road
Murrieta, California 92563
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Murrieta, CA
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Nashville, Tennessee 37211
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Nashville, TN
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Norfolk, Virginia 23502
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Norfolk, VA
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Ogden, Utah 84405
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Ogden, UT
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Palmetto Bay, Florida
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Palmetto Bay, FL
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Pasadena, Texas 77504
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Pasadena, TX
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9050 Pines Boulevard
Pembroke Pines, Florida 33024
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Pembroke Pines, FL
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Pleven,
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Sweetwater, Florida 33172
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Sweetwater, FL
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Tomball, Texas 77375
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Tomball, TX
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