Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/12/2014
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

Mr R Calvert

ORCID ID

Contact details

Specialist Register in Urology
Bedford Hospital NHS Trust
South Wing
Kempston
Bedford
MK42 9DJ
United Kingdom

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes