Randomised placebo-controlled trial of intravenous methylprednisolone in relapsed multiple sclerosis patients without the need for ranitidine cover
| ISRCTN | ISRCTN46231139 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46231139 |
| Protocol serial number | N0295122823 |
| Sponsor | Department of Health (UK) |
| Funder | University Hospitals Coventry and Warwickshire NHS Trust |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 18/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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 MA Belhag
Scientific
Scientific
Neurology Department
University Hospitals Coventry and Warwickshire NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Randomised placebo-controlled trial of intravenous methylprednisolone in relapsed multiple sclerosis patients without the need for ranitidine cover |
| Study objectives | Is it safe to administer intravenous methylprednisolone treatment without the need for gastric-mucosal protection by ranitidine? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous System Diseases: Multiple sclerosis (MS) |
| Intervention | Sixty matched patients from those admitted for intravenous methylprednisolone treatment for their relapsed multiple sclerosis. Thirty will be randomised for an additional oral ranitidine cover, and the other 30 will be randomised for placebo. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methylprednisolone, ranitidine |
| Primary outcome measure(s) |
Between group differences in the absolute number of those who develop gastro-intestinal symptoms. |
| Key secondary outcome measure(s) |
The number of those who develop gastro-intestinal symptoms who on clinical grounds require further investigation of their gastric mucosa for a possible ulcer or erosions in the 3, 6 and 12 months follow up durations. |
| Completion date | 30/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Key inclusion criteria | Sixty matched patients from those admitted for intravenous methylprednisolone treatment for their relapsed multiple sclerosis. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 24/07/2003 |
| Date of final enrolment | 30/11/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospitals Coventry and Warwickshire NHS Trust
Coventry
CV2 2DX
United Kingdom
CV2 2DX
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/01/2016: no publications found on PubMed.
