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

Completed

• Conditions: Acute exacerbations of ulcerative colitis; Nutritional, Metabolic, Endocrine; Ulcerative colitis

• Registration Number: ISRCTN14133410
• Lead Sponsor: Flexpharm Ltd. (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

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
10. Participation in an experimental drug study in the preceding three months
11. Previous resistance to conventional daily 40 mg prednisolone over a period of two weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified