Acute exacerbations of ulcerative colitis Digestive System Ulcerative colitis
Conditions
Interventions
Three treatment groups:
Group A: 40 mg Predocol per day in divided doses for eight weeks
Group B: 60 mg Predocol per day in divided doses for eight weeks
Group C: 40 mg enteric coated prednisolone eac
Sponsors
Flexpharm Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be enrolled in the study patients are required to meet the following inclusion criteria: 1. Histologically confirmed ulcerative colitis, considered suitable for therapeutic treatment with Predocol or prednisolone 2. Active inflammation of the bowel categorised as mild, moderate or severe 3. At least 18 years old 4. Given written informed consent to participate
Exclusion criteria
Exclusion criteria: Patients are excluded from the study if any of the following applies: 1. Have taken more than three doses of steroids within the past month before entry into the study 2. Pregnant and nursing mothers 3. Significant renal, hepatic, cardiovascular or neuropsychiatric impairment, diabetes, Acquired Immune Deficiency Syndrome (AIDS) (or Human Immunodeficiency Virus [HIV]) or other chronic infections, osteoporosis, a transplanted organ, malignancy, lymphoproliferative disease, or substance abuse 4. Have had opportunistic or serious infections, such as hepatitis, pneumonia, or pyelonephritis in the previous three months 5. Require the concomitant use of drugs likely to suppress daytime gastric acidity (omeprazole or large doses of H2 antagonist drugs) 6. Known to have Crohn's disease 7. Considered by their physician unlikely to be able to comply with the protocol 8. Very severe colitis evidenced by toxic dilatation or for whom admission or surgery seems imminent 9. Female patients of child bearing potential. Such patients must use a reliable form of contraception throughout the period of the study to be eligible for the study 10. Have taken part in an experimental drug study in the preceding three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Efficacy, measured using the Powell-Tuck score, assessed during and up to week 8 of treatment (final visit at week 8) 2. Safety, measured using levels of cortisol 30 minutes and one hour after synacthen injection on the last visit of the study, 3 to 7 days after the patient has completed eight weeks of treatment with study drug. Changes in cortisol levels from the screening synacthen test will also be analysed | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy, measured using the physician's clinical grading and the physician's global assessment, assessed during and up to week 8 of treatment (final visit at week 8). 2. Safety, including reported adverse events and major changes in laboratory data, and findings of potential clinical concern, measured during and up to 3 - 7 days after final visit at end of week 8 of treatment | — |
Countries
United Kingdom
Outcome results
None listed