Back to resultsSafety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis
Primary Purpose
Colitis, Ulcerative
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Delayed and extended release mesalazine
Sponsored by
About this trial
This is an interventional treatment trial for Colitis, Ulcerative
Eligibility Criteria
Inclusion Criteria:
- newly diagnosed or diagnosis of relapsing (relapsed <= 6 weeks to baseline) mild to moderate ulcerative colitis
- women not of childbearing potential or WOCP who agreed to use an effective contraceptive method
Exclusion Criteria:
- severe ulcerative colitis or relapsed for > 6 weeks prior to baseline
- subjects who had relapsed on maintenance therapy with doses of mesalazine > 2.0 g/day
- subjects with Crohn's disease, proctitis, bleeding disorders or active peptic ulcer disease
- subjects with asthma if they were known to be mesalazine-sensitive
- subjects who were at immediate or significant risk of toxic megacolon
- subjects who had previous resective colonic surgery
- subjects who had moderate or severe renal impairment
Sites / Locations
- University of Pennsylvania
Outcomes
Primary Outcome Measures
Percentage of subjects in remission (Ulcerative Colitis Disease Activity Index score of <= 1, with scores of 0 for rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline
Secondary Outcome Measures
Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score
Change in the UC-DAI score
Change in symptoms (rectal bleeding and stool frequency)
Change in sigmoidoscopic (mucosal) appearance
Time to withdrawal from the start of study medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00503243
Brief Title
Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis
Official Title
A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 30, 2003 (Actual)
Primary Completion Date
January 17, 2005 (Actual)
Study Completion Date
January 17, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
5. Study Description
Brief Summary
The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily ([BID] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative colitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Delayed and extended release mesalazine
Primary Outcome Measure Information:
Title
Percentage of subjects in remission (Ulcerative Colitis Disease Activity Index score of <= 1, with scores of 0 for rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score
Time Frame
8 weeks
Title
Change in the UC-DAI score
Time Frame
8 weeks
Title
Change in symptoms (rectal bleeding and stool frequency)
Time Frame
2, 4 and 8 weeks
Title
Change in sigmoidoscopic (mucosal) appearance
Time Frame
8 weeks
Title
Time to withdrawal from the start of study medication
Time Frame
Throughout the study period of 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
newly diagnosed or diagnosis of relapsing (relapsed <= 6 weeks to baseline) mild to moderate ulcerative colitis
women not of childbearing potential or WOCP who agreed to use an effective contraceptive method
Exclusion Criteria:
severe ulcerative colitis or relapsed for > 6 weeks prior to baseline
subjects who had relapsed on maintenance therapy with doses of mesalazine > 2.0 g/day
subjects with Crohn's disease, proctitis, bleeding disorders or active peptic ulcer disease
subjects with asthma if they were known to be mesalazine-sensitive
subjects who were at immediate or significant risk of toxic megacolon
subjects who had previous resective colonic surgery
subjects who had moderate or severe renal impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17234558
Citation
Lichtenstein GR, Kamm MA, Boddu P, Gubergrits N, Lyne A, Butler T, Lees K, Joseph RE, Sandborn WJ. Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis. Clin Gastroenterol Hepatol. 2007 Jan;5(1):95-102. doi: 10.1016/j.cgh.2006.10.025.
Results Reference
result
Links:
URL
http://www.lialda.com/Professional/pdf/pi.pdf
Description
FDA-approved label, US only
URL
http://www.fda.gov/opacom/7alerts.html
Description
FDA Recall information
Learn more about this trial
Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis
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