Clinical trial NCT00503243: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colitis, Ulcerative
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score
timeFrame: 8 weeks
measure: Change in the UC-DAI score
timeFrame: 8 weeks
measure: Change in symptoms (rectal bleeding and stool frequency)
timeFrame: 2, 4 and 8 weeks
measure: Change in sigmoidoscopic (mucosal) appearance
timeFrame: 8 weeks
measure: Time to withdrawal from the start of study medication
timeFrame: Throughout the study period of 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
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.