Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Hyoscine butylbromide (Buscopan®)
Primary outcome measure
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 study start date
20/01/2004
Overall study end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients undergoing pelvic magnetic resonance imaging.
Participant type(s)
Patient
Age group
Not Specified
Sex
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
England, United Kingdom
Study 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
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2007 | Yes | No |