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ISRCTN
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ISRCTN68855603
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ClinicalTrials.gov identifier
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Public title
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A double-blind comparative study of Predocol 40 and 60 mg per day and prednisolone 40 mg per day, comparing clinical efficacy, safety and adrenal function in the treatment of acute exacerbations of ulcerative colitis
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Scientific title
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Acronym
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PIAF
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Serial number at source
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Predocol 2001
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Study hypothesis
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The primary objectives of the study are to compare the clinical efficacy and safety of treatment with either orally administered prednisolone Metasulfobenzoate (MSB) (Predocol) or standard oral prednisolone in patients with acute exacerbations of ulcerative colitis. Treatment will be administered for eight weeks, and adrenal function will be measured before and after the treatment period by the synacthen test.
Please note that this study provides additional efficacy data to another study entitled: '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' [ISRCTN14133410] and, in particular, focuses on adrenal safety.
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Ethics approval
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Initial ethics approval received from the Cambridge Local Research Ethics Committee (LREC) on the 27th June 2000. Further approval was received from the Eastern Region Multi-Centre Research Ethics Committee (MREC) on the 29th January 2003 (ref: 02/5/58).
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Study design
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The study is a double-blind randomised study in patients with ulcerative colitis randomised to one of three treatment groups.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Acute exacerbations of ulcerative colitis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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18/05/2001
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Anticipated end date
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29/11/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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120 patients meeting eligibility requirements
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Interventions
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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 each day in divided doses, reducing to zero over eight weeks. Dummy capsules will be used to maintain blinding
Safety follow-up for all groups is for 3 - 7 days post final visit at week 8.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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
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Sources of funding
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Enterotech Ltd (Jersey)
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Trial website
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Publications
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Contact name
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Dr
Stephen
Middleton
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Address
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Department of Gastroenterology
Addenbrookes Hospital
Cambridge University Hospitals NHS Foundation Trust
Hills Road
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City/town
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Cambridge
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Zip/Postcode
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CB2 0QQ
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Country
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United Kingdom
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Sponsor
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Flexpharm Ltd (UK)
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Address
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Elite House
Hill Farm Industrial Estate
Leavesden
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City/town
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Watford
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Zip/Postcode
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WD25 7SA
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Country
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United Kingdom
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Date applied
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11/10/2007
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Last edited
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08/11/2007
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Date ISRCTN assigned
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08/11/2007
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