Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Jonathan M. Rhodes


Contact details

Henry Wellcome Laboratory of Molecular & Cellular Gastroenterology
Department of Medicine
University of Liverpool
Crown Street
L69 3BX
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

Predocol 9804

Study information

Scientific title



Study hypothesis

The primary objective of the study was to assess the safety of predocol, a controlled delivery formulation of orally administered prednisolone metasulfobenzoate, administered at two dose levels compared with oral prednisolone and with each other, in patients with ulcerative colitis.

Ethics approval

Approved by the Central Ethics Committees of Southeast Multicentre Research Ethics Committee (MREC) and Kent and Medway Strategic Health Authority, Preston Hall, 1999

Study design

Multicentre, randomised, double-blind study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Acute exacerbations of ulcerative colitis


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.

Intervention type



Not Specified

Drug names

Prednisolone metasulfobenzoate (predocol), oral prednisolone

Primary outcome measure

The primary criterion for efficacy was the patient’s global visual analogue scale (VAS) assessment of symptoms.

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.

Secondary outcome measures

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

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.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

Ireland, United Kingdom

Trial participating centre

Henry Wellcome Laboratory of Molecular & Cellular Gastroenterology
L69 3BX
United Kingdom

Sponsor information


Flexpharm Ltd. (UK)

Sponsor details

Elite House
Hill Farm Industrial Estate
WD25 7SA
United Kingdom

Sponsor type




Funder type


Funder name

Enterotech Ltd (Jersey)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Results in

Publication citations

  1. Results

    Rhodes JM, Robinson R, Beales I, Pugh S, Dickinson R, Dronfield M, Speirs CJ, Wilkinson P, Wilkinson SP, Clinical trial: oral prednisolone metasulfobenzoate (Predocol) vs. oral prednisolone for active ulcerative colitis., Aliment. Pharmacol. Ther., 2008, 27, 3, 228-240, doi: 10.1111/j.1365-2036.2007.03569.x.

Additional files

Editorial Notes