Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Predocol 2001
Study information
Scientific title
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
Acronym
PIAF
Study hypothesis
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.
Ethics approval
Cambridge Local Research Ethics Committee (LREC) on 27/06/2000.
Further approval was received from Eastern Region Multi-Centre Research Ethics Committee (MREC) on the 29/01/2003 (ref: 02/5/58)
Study design
The study is a double-blind randomised study in patients with ulcerative colitis randomised to one of three treatment groups.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute exacerbations of ulcerative colitis
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Prednisolone Metasulfobenzoate (MSB) (Predocol), prednisolone
Primary outcome measure
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 outcome measures
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
Overall trial start date
18/05/2001
Overall trial end date
29/11/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120 patients meeting eligibility requirements
Participant 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
Recruitment start date
18/05/2001
Recruitment end date
29/11/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Gastroenterology
Cambridge
CB2 0QQ
United Kingdom
Funders
Funder type
Industry
Funder name
Enterotech Ltd (Jersey)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list