Acute exacerbations of ulcerative colitis Nutritional, Metabolic, Endocrine Ulcerative colitis
Conditions
Interventions
Active drug:
Predocol (prednisolone metasulphobenzoate) 40 mg or 60 mg were provided as four (+2 placebo) or six capsules oral daily with appropriate overcoating to retain blinding. Dosing was for six
Sponsors
Flexpharm Ltd. (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: The primary criterion for efficacy was the patient?s global visual analogue scale (VAS) assessment of symptoms. Safety: The primary safety criterion was the patient's overall assessment of the severity of steroid-related side-effects during the acute phase of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1. Secondary criteria were the physician?s global VAS assessment of patient?s progress 2. Physician?s clinical assessment of ulcerative colitis symptoms (Powell-Tuck) 3. Sigmoidoscopy grading 4. Number of patients requiring escape therapy 5. Time to stopping medication due to disease exacerbation 6. Health status and healthcare usage Safety: Secondary criteria were the severity of listed side-effects and the incidence of adverse experiences, HbA1c, C-reactive protein (CRP), testosterone or oestrogen, abnormal laboratory data and findings of clinical concern. Patients at selected centres were also assessed for bone mineral density and osteocalcin levels. | — |
Countries
Ireland, United Kingdom
Outcome results
None listed