A safety and efficacy study of a novel formulation of prednisolone metasulfobenzoate (predocol) in the induction of remission and maintenance in patients with ulcerative colitis

Flexpharm Ltd. (UK)0 sites180 target enrollmentApril 28, 2006

Overview

No summary available.

Registry

who.int

Start Date

April 28, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Flexpharm Ltd. (UK)

•To be enrolled in the study patients were required to meet the following inclusion criteria:
•1\. Have histologically confirmed ulcerative colitis considered suitable for therapeutic treatment with predocol or prednisolone
•2\. Have active rectal inflammation extending at least to the proximal descending sigmoid junction, which was categorised as mild, moderate or severe, using the Baron Grade for mucosal appearance at sigmoidoscopy as follows: 0: normal; 1: erythema or granularity only. No contact bleeding; 2: friable but no spontaneous bleeding; 3: spontaneous bleeding
•3\. Be aged 18 to 85 years
•4\. Give written informed consent to participate

•Patients were excluded from the study if any of the following applied:
•1\. Severe fulminating ulcerative colitis
•2\. Having taken more than three daily doses of oral steroid therapy or any steroid enemas in the month before study entry
•3\. Immunosuppressive therapy other than maintenance therapy with azathioprine
•4\. Pregnant and nursing mothers
•5\. Significant renal, hepatic, cardiovascular or neuropsychiatric impairment, diabetes or alcohol abuse
•6\. The concomitant use of drugs likely to suppress daytime gastric acidity (proton pump inhibitors or large doses of H2 antagonists)
•7\. Crohn's disease
•8\. Unlikely to be able to comply with the protocol
•9\. Female patients of child\-bearing potential unless using a reliable form of contraception throughout the period of the study