Study name |
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 |
Methods |
Participants were randomized to 1 of 2 groups:
Mesalamine (4g extended release granules)
Placebo comparator
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Participants |
Inclusion criteria:
Men or women aged 18 to 75 years
Mild to moderate ulcerative colitis
Exclusion criteria:
Disease limited to proctitis < 15 cm
Short bowel syndrome
Prior colon resection surgery
History of severe/fulminant ulcerative colitis
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
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Interventions |
4g extended release granules of Mesalamine and placebo |
Outcomes |
Primary outcomes:
Proportion of participants with remission (time frame: at week 8); defined by the Clinical and Endoscopic Response Score based on a modified 9‐point Mayo score
Secondary outcomes:
Proportion of participants with remission in the primary endpoint and the Physician's Global Assessment (PGA) (time frame: at week 8)
Time to cessation of rectal bleeding (time frame: up to week 8)
Severity of adverse events (time frame: up to week 16)
Incidence of adverse events (time frame: up to week 16)
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Starting date |
October 2015 |
Contact information |
Clinical Development Support: DK0-Disclosure@ferring.com
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Notes |
This study is currently recruiting participants The estimated completion date is 28 February 2018 |