Condition category
Nervous System Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
18/01/2016
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 MA Belhag

ORCID ID

Contact details

Neurology Department
University Hospitals Coventry and Warwickshire NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0295122823

Study information

Scientific title

Randomised placebo-controlled trial of intravenous methylprednisolone in relapsed multiple sclerosis patients without the need for ranitidine cover

Acronym

Study hypothesis

Is it safe to administer intravenous methylprednisolone treatment without the need for gastric-mucosal protection by ranitidine?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Methylprednisolone, ranitidine

Primary outcome measures

Between group differences in the absolute number of those who develop gastro-intestinal symptoms.

Secondary outcome measures

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.

Overall trial start date

24/07/2003

Overall trial end date

30/11/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Sixty matched patients from those admitted for intravenous methylprednisolone treatment for their relapsed multiple sclerosis.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

24/07/2003

Recruitment end date

30/11/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire NHS Trust
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospitals Coventry and Warwickshire NHS Trust

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

18/01/2016: no publications found on PubMed.