Study of COLAL-PRED® in the treatment of moderate acute ulcerative colitis
| ISRCTN | ISRCTN71669877 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71669877 |
| ClinicalTrials.gov (NCT) | NCT00299013 |
| Protocol serial number | ATL2502/020/CL |
| Sponsor | Alizyme (UK) |
| Funder | Alizyme (UK) |
- Submission date
- 10/03/2006
- Registration date
- 29/03/2006
- Last edited
- 31/01/2019
- 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
Prof Christopher J Hawkey
Scientific
Scientific
University Hospital
Nottingham
NG7 2UH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind double-dummy active-comparator parallel-group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Study of COLAL-PRED® in the treatment of moderate acute ulcerative colitis |
| Study objectives | The aim of this study is to investigate whether COLAL-PRED® is non-inferior in terms of efficacy and superior in terms of safety to that of conventional prednisolone in the treatment of moderate acute ulcerative colitis. |
| Ethics approval(s) | Southampton and South West Hampshire Research Ethics Committees (A), 11/10/2005, ref: 05/Q1702/128 |
| Health condition(s) or problem(s) studied | Moderate acute ulcerative colitis |
| Intervention | Patients are randomised to receive one of the following interventions: 1. Capsules containing prednisolone metasulfobenzoate sodium in a colonic delivery system 2. Prednisolone tablets 3. Matching placebo capsules and tablets |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | COLAL-PRED® containing prednisolone metasulfobenzoate sodium |
| Primary outcome measure(s) |
1. Responder analysis for reduction in disease activity index (DAI) score |
| Key secondary outcome measure(s) |
Treatment responder analysis of patients who are both efficacy and safety responders |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 750 |
| Key inclusion criteria | 1. Endoscopically confirmed diagnosis of ulcerative colitis 2. Score of 6-10 on the disease activity index (DAI) 3. Moderate to severe mucosal appearance |
| Key exclusion criteria | 1. Previous colonic surgery 2. Other treatments for ulcerative colitis that have not been stabilised 3. Clinically significant diabetes 4. Heart failure 5. Unstable angina 6. Cirrhosis 7. Renal failure 8. History of tuberculosis |
| Date of first enrolment | 07/03/2006 |
| Date of final enrolment | 31/03/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
- Australia
- Belgium
- Czech Republic
- Denmark
- France
- Germany
- Hungary
- Israel
- Italy
- Poland
- Russian Federation
- South Africa
- Spain
- Sweden
Study participating centre
University Hospital
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
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
31/01/2019: No publications found. Added a company presentation of results to publication and dissemination plan
11/04/2017: No publications found in PubMed, verifying study status with principal investigator
