Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis|
- Proportion of subjects who were relapse free after 6 months of treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Study Completion Date:||October 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Placebo Comparator: 2
Matching placebo capsules (4 capsules) were administered orally QD, in the morning
Active Comparator: 1
Drug: Granulated mesalamine
0.375 g of mesalamine granules were encapsulated in a hard gelatin shell. 1.5 g of eMG (4 capsules) were administered orally QD, in the morning
Other Name: mesalamine pellets
This is a phase 3, multicenter, double-blind, randomized, placebo controlled study evaluating the effectiveness and safety of eMG 1.5 g given once daily (QD) compared with placebo in approximately 300 subjects with demonstrated remission from UC. Eligible subjects are randomized in a 2:1 ratio (active:placebo) to receive 1 of 2 treatments: 1.5g eMG QD (four capsules total) or matching placebo capsules QD for 6 months.
The study consists of a Screening phase (completed within 7 days prior to randomization), a Treatment phase (6 months), and a Follow-up visit (2 weeks after end-of-study [EOS] visit). The Treatment phase consists of 4 scheduled study visits: Visit 1 (Baseline)/Randomization (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4/EOS (Month 6).
To compare the maintenance of remission from mild to moderate ulcerative colitis (UC) as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment with encapsulated mesalamine granules (eMG) at 1.5 g QD, as compared with placebo.
To compare the safety and tolerability of long-term dosing with eMG at 1.5 g QD as compared with placebo in the maintenance of remission from mild to moderate UC.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744016
|United States, Connecticut|
|Bristol, Connecticut, United States, 06010|
|Study Director:||Audrey L Shaw, Ph.D.||Valeant Pharmaceuticals International, Inc.|