Condition category
Not Applicable
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/04/2012
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 B Taylor

ORCID ID

Contact details

X-Ray Diagnostic
Christie Hospital NHS Trust
Wimslow Road
Withington
Manchester
M20 4BX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0063139427

Study information

Scientific title

Acronym

Study hypothesis

To determine whether intravenous hyoscine butylbromide (Buscopan®) results in a significant improvement in magnetic resonance (MR) image quality and improves diagnostic accuracy, thereby benefitting patients.

Ethics approval

Not provided at time of registration

Study design

A cohort observation, randomised single-blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Magnetic resonance imaging (MRI)

Intervention

Before pelvic magnetic resonance imaging patient will received either intravenous hyoscine butylbromide or a placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Hyoscine butylbromide (Buscopan®)

Primary outcome measures

Overall image quality and visualisation of individual pelvic structures and visualisation of tumours on MR images, both with and without Buscopan®.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

20/01/2004

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing pelvic magnetic resonance imaging.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

20/01/2004

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

X-Ray Diagnostic
Manchester
M20 4BX
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Christie Hospital NHS Trust (UK)

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

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17920868

Publication citations

  1. Results

    Johnson W, Taylor MB, Carrington BM, Bonington SC, Swindell R, The value of hyoscine butylbromide in pelvic MRI., Clin Radiol, 2007, 62, 11, 1087-1093, doi: 10.1016/j.crad.2007.05.007.

Additional files

Editorial Notes