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
| ISRCTN | ISRCTN14133410 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14133410 |
| Secondary identifying numbers | Predocol 9804 |
- Submission date
- 01/03/2006
- Registration date
- 28/04/2006
- Last edited
- 06/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jonathan M. Rhodes
Scientific
Scientific
Henry Wellcome Laboratory of Molecular & Cellular Gastroenterology
Department of Medicine
University of Liverpool
Crown Street
Liverpool
L69 3BX
United Kingdom
| j.m.rhodes@liverpool.ac.uk |
Study information
| Study design | Multicentre, randomised, double-blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | TOPPIC |
| Study objectives | 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(s) | Approved by the Central Ethics Committees of Southeast Multicentre Research Ethics Committee (MREC) and Kent and Medway Strategic Health Authority, Preston Hall, 1999 |
| Health condition(s) or problem(s) studied | Acute exacerbations of ulcerative colitis |
| Intervention | 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 | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Prednisolone metasulfobenzoate (predocol), oral prednisolone |
| Primary outcome measure | Efficacy: The primary criterion for efficacy was the patients global visual analogue scale (VAS) assessment of symptoms. Safety: 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 | Efficacy: 1. Secondary criteria were the physicians global VAS assessment of patients progress 2. Physicians 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 Safety: 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 study start date | 01/11/2000 |
| Completion date | 01/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 180 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2000 |
| Date of final enrolment | 01/02/2005 |
Locations
Countries of recruitment
- England
- Ireland
- United Kingdom
Study participating centre
Henry Wellcome Laboratory of Molecular & Cellular Gastroenterology
Liverpool
L69 3BX
United Kingdom
L69 3BX
United Kingdom
Sponsor information
Flexpharm Ltd. (UK)
Industry
Industry
Elite House
Hill Farm Industrial Estate
Leavesden
Watford
WD25 7SA
United Kingdom
Funders
Funder type
Industry
Enterotech Ltd (Jersey)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/02/2008 | Yes | No |
