Clinical trial NCT00548574: Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis
Official title: A Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-10-24
Enrollment: 343
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 primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day once daily versus placebo


Eligibility criteria: Inclusion Criteria:

* newly diagnosed or relapsing mild to moderate UC (score of 4-10 (inclusive) on the UC-DAI scale, with a sigmoidoscopy score of =\> 1 and a PGA \<=2) with compatible histology
* females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy test at screening and were on adequate contraception

Exclusion Criteria:

* subjects with relapsing UC who were in relapse for \> 6 weeks prior to baseline
* subjects who relapsed on maintenace therapy with doses of mesalazine =\> 2g/day
* subjects who had unsuccessfully treated their current relapse with steroids or a mesalazine dose of \> 2g/day
* subjects with Crohn's disease, proctitis, bleeding disorders, active peptic ulcer disease, previous colonic surgery, or those at an immediate risk of toxic megacolon or a stool culture positive for enteric pathogens
* subjects who had used systemic or rectal steroids within the last 4 weeks, immunosuppressants wihtin the last 6 weeks or anti-inflammatory drugs on a repeat basis within 7 days prior to the baseline visit
* subjects with hypersensitivity to salicylates and subjects with moderate/severe renal impairment

Primary outcomes:
measure: Percentage of subjects in remission (UC-DAI score <=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 from baseine in UC-DAI score, symptoms, sigmoidscopy score, and PGA
timeFrame: 8 weeks
measure: Clinical remission defined as subjects who scored 0 for both the total stool frequency and the total rectal bleeding score
timeFrame: 8 weeks
measure: Treatment failure defined as unchanged, worsened missing or imcomplete UC-DAI score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda General Hospital Dept of Gastroenterology
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Kamm MA, Sandborn WJ, Gassull M, Schreiber S, Jackowski L, Butler T, Lyne A, Stephenson D, Palmen M, Joseph RE. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007 Jan;132(1):66-75; quiz 432-3. doi: 10.1053/j.gastro.2006.10.011. Epub 2006 Oct 12.