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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 remission

Time 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

Page last updated: August 23, 2015

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