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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN14133410 |
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Date of registration:
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28/04/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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Date of first enrolment:
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01/11/2000 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN14133410 |
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Study type:
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Interventional |
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Study design:
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Multicentre, randomised, double-blind study (Treatment)
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Phase:
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Countries of recruitment
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Ireland
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Jonathan M.
Rhodes |
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Address:
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Henry Wellcome Laboratory of Molecular & Cellular Gastroenterology
Department of Medicine
University of Liverpool
Crown Street
L69 3BX
Liverpool
United Kingdom |
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Telephone:
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Email:
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j.m.rhodes@liverpool.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute exacerbations of ulcerative colitis
Nutritional, Metabolic, Endocrine
Ulcerative colitis
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Intervention(s)
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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 months.
Active comparator:
EC prednisolone in a reducing dosage regimen, six capsules were provided to retain blinding (starting dose of 40 mg reducing to 5 mg over the two-month treatment period according to a fixed protocol). Dosing with the EC prednisolone was for two months of the overall six months of the study with placebo being provided for the remaining four months.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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Predocol 9804
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Source(s) of Monetary Support
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Enterotech Ltd (Jersey)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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