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

ISRCTN	ISRCTN68855603
DOI	https://doi.org/10.1186/ISRCTN68855603
Protocol serial number	Predocol 2001
Sponsor	Flexpharm Ltd (UK)
Funder	Enterotech Ltd (Jersey)

Submission date: 11/10/2007
Registration date: 08/11/2007
Last edited: 14/02/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Middleton
Scientific

Department of Gastroenterology
Addenbrookes Hospital
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Study information

Primary study design	Interventional
Study design	The study is a double-blind randomised study in patients with ulcerative colitis randomised to one of three treatment groups.
Secondary study design	Randomised controlled trial
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
Study acronym	PIAF
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Prednisolone Metasulfobenzoate (MSB) (Predocol), prednisolone
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	29/11/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	18/05/2001
Date of final enrolment	29/11/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Gastroenterology

Cambridge
CB2 0QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

14/02/2017: No publications found in PubMed, verifying study status with principal investigator