Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0040122630
Study information
Scientific title
A prospective, randomised, double-blind placebo-controlled trial of effects of glyceryl trinitrate ointment on the pain experiences during transdermal ultrasound guided biopsy of the prostate
Acronym
Study hypothesis
To test the hypothesis: Topical 0.2% GTN ointment reduced the discomfort or pain experiences during transrectal ultrasound guided biopsy of the prostate. Results will be submitted for presentation to a national/international urology meeting.
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
Condition
Urological and Genital Diseases: Prostate biopsy
Intervention
Glyceryl trinitrate ointment vs placebo
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2003
Overall trial end date
01/09/2003
Reason abandoned
Eligibility
Participant inclusion criteria
After logistical considerations, we propose to aim for 50 patients in each group so that we might detect a difference in pain score 1/10 with a power of 90% and the aforementioned assumptions. It should be possible to complete this study in less than 6 months.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2003
Recruitment end date
01/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bedford Hospital NHS Trust
Bedford
MK42 9DJ
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Bedford 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