Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses1 and a Physician Global Assessment of <2). The original diagnosis of UC must be established by sigmoidoscopy, colonoscopy, or barium enema and have compatible histology.
Conditions
Sponsors
Shire Pharmaceutical Development Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults aged 18 and over, male and female -Women of childbearing potential must use an effective contraceptive method while the subject is on the study treatment and must agree to not become pregnant during 30 days after the last dose of the study drug. - Subject who are newly diagnosed or have diagnosis of relapsing mild to moderate UC. Diagnosis of UC originally must be established by sigmoidoscopy, colonoscopy, or barium enema and have compatible histology. - Subjects who, in the investigator's opinion are not likely to respond to 5-ASA doses of 2.4 g/day should not be included. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Severe UC according to the Physicians Global Asswssmant or subjects that have been in relapse for >6 weeks prior baselina. - Subjects who have relapsed on maintenance therapy with doses of 5-ASA>2g/day. If a subject had a recent 5-ASA dose reduction from >2g/day to 2 mg/dl) are contra-indicated for the treatment with 5-ASA compounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the percentage of subjects in remission after 8 weeks of treatment for the three treatment groups SPD476 2.4 g/day given twice daily and 4.8 g/day given once daily and placebo. Remission is defined as an Ulcerative Colitis Disease Activity Index (UC-DAI) score 3 points from baseline in the overall UC-DAI score for the three treatment groups. - To compare the percentage subjects in remission after 8 week of treatment between two doses of SPD476. - To compare the change in the UC-DAI score from baseline to 8 week of treatment between the three treatment groups. - To compare the change in symptoms (rectal bleeding and stool frequency) from baseline to 2,4 and 8 weeks of treatment between the three treatment groups. - To compare the time to withdrawal between the 3 treatment groups. To compare the change in sigmoidoscopic (mucosal)appearance from baseline to 8 weeks of treatment between the 3 treatment groups. - To assess the safety and tolerability of SPD476 administered as 2.4 g/day given BID and 4.8 g/day given OD as compared to placebo.;Primary end point(s): The primary efficacy endpoint for this study is remission assessed by the UC-DAI score. It consists of 4 individual parameters (stool frequency, rectal bleeding, mucosal appearance and Physicians Global Assessment). All 4 parameters will be assessed individually on a scale from 0-3. Remission is defined as an UC-DAI score of <1, with score of zero for stool frequency and rectal bleeding and sigmoidoscopy score reduction of 1 point or more from baseline. Improvement of symptoms from baseline to 2,4, and 8 weeks will be assessed by using two individual parameters of the UC-DAI: stool frequency, rectal bleeding. Safety and tolerability will be assessed by adverse events, laboratory testing (hematology, biochemistry and urinalysis), physical examination and vital signs. | — |
Countries
Czech Republic
Outcome results
None listed