Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ulcerative Colitis
Intervention: Mesalamine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s): Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals
Overall contact: Clinical Development Support, Email: DK0-Disclosure@ferring.com
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Proportion of subjects in remission
Secondary outcome: Proportion of subjects in clinical remissionTime to relapse Severity of adverse events Incidence of adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Clinical Development Support, Email: DK0-Disclosure@ferring.com Additional Information
Starting date: September 2015
Last updated: August 12, 2015
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