Condition category
Digestive System
Date applied
11/10/2007
Date assigned
08/11/2007
Last edited
15/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Middleton

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Predocol 2001

Study information

Scientific title

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 measures

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

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

Sponsor information

Organisation

Flexpharm Ltd (UK)

Sponsor details

Elite House
Hill Farm Industrial Estate
Leavesden
Watford
WD25 7SA
United Kingdom

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes