A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.

Shire Pharmaceutical Development Inc0 sites255 target enrollmentJuly 1, 2004

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses<to baseline) mild to moderate ulcerative colitis (UC). The original diagnosis of UC (total score of 4-10 on the Ulcerative Colitis Disease Activity Index and with a sigmoidoscopy score of >1 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.
Sponsor: Shire Pharmaceutical Development Inc
Enrollment: 255
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

July 1, 2004

End Date

January 17, 2005

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Shire Pharmaceutical Development Inc

•\- 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

•\-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 \<2g/day relapses within 2 weeks of thatv dose reduction, the subject will not be eligible .
•\- Cron's Disease, proctitis, bleeding disorder, or active ulcer disease.
•\-Subjects with Asthma if they are known to be 5\-ASA sensitive.
•\-Subjects who in the opinion of the investigator are at immediate or significant risk of toxic megacolon.¨
•\-Previous colon surgary.
•\- Subjects with moderate or severe renal impairment (defined as a creatinine level of \>2 mg/dl) are contra\-indicated for the treatment with 5\-ASA compounds