Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT00744016|
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : December 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Granulated mesalamine Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||305 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||October 2007|
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
- Proportion of subjects who were relapse free after 6 months of treatment. [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744016
|United States, Connecticut|
|Bristol, Connecticut, United States, 06010|
|Study Director:||Audrey L Shaw, Ph.D.||Valeant Pharmaceuticals International, Inc.|