Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001104842
Ethics application status
Approved
Date submitted
8/04/2009
Date registered
16/10/2012
Date last updated
26/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of Diltiazem cream for reducing pain associated with the biopsy of the prostate
Scientific title
Does Topical Diltiazem before transrectal ultrasonography (TRUS)-guided biopsy of the prostate reduce the pain associated with the procedure?: A randomised controlled trial
Secondary ID [1] 281388 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain associated with Prostate biopsy 4579 0
Condition category
Condition code
Renal and Urogenital 4874 4874 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application of Diltiazem paste(1 gram) prior to Ultra sound scan guided biopsy of prostate gland
Intervention code [1] 4342 0
Diagnosis / Prognosis
Intervention code [2] 285877 0
Early detection / Screening
Intervention code [3] 285878 0
Treatment: Other
Comparator / control treatment
Placebo ( paraffin and applied one off before the biopsy)
Control group
Placebo

Outcomes
Primary outcome [1] 5725 0
Reduction of pain using questionnaires and 100mm Visual analogue scale.
No other questionnaire was used. We constructed our own questionnaire and asked the patients to indicate their pain during probe insertion, during biopsy and just before leaving the department.
Timepoint [1] 5725 0
During the biopsy and immediately after the biopsy and then 10 min post biopsy when patients were leaving the department
Secondary outcome [1] 241661 0
N/A
Timepoint [1] 241661 0
N/A

Eligibility
Key inclusion criteria
Patients undergoing USS guided biopsy of prostate
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Liver/Renal failure
Patients already on diltiazem

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 1723 0
New Zealand
State/province [1] 1723 0
manawatu

Funding & Sponsors
Funding source category [1] 4767 0
Hospital
Name [1] 4767 0
Midcentral distric health board
Country [1] 4767 0
New Zealand
Primary sponsor type
Hospital
Name
Palmerston North Hospital
Address
Palmerston North Hospital
50 Ruahine Street
Private Bag 11036
Palmerston North 4442
New Zealand
Country
New Zealand
Secondary sponsor category [1] 4304 0
None
Name [1] 4304 0
Address [1] 4304 0
Country [1] 4304 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6815 0
NZ Central regional ethics committee
Ethics committee address [1] 6815 0
Ethics committee country [1] 6815 0
New Zealand
Date submitted for ethics approval [1] 6815 0
15/04/2009
Approval date [1] 6815 0
17/06/2009
Ethics approval number [1] 6815 0
CEN/09/06/034

Summary
Brief summary
The purpose of the study is to see if use of diltiazem cream during biopsy of the prostate can reduce the pain associated with the procedure.
Trial website
nA
Trial related presentations / publications
tba
Public notes

Contacts
Principal investigator
Name 29477 0
Address 29477 0
Country 29477 0
Phone 29477 0
Fax 29477 0
Email 29477 0
Contact person for public queries
Name 12724 0
Homi Zargar
Address 12724 0
Urology department
Palmerston North Hospital
50 Ruahine Street
Private Bag 11036
Palmerston North 4442
New Zealand
Country 12724 0
New Zealand
Phone 12724 0
+64 6 350 9169
Fax 12724 0
Email 12724 0
[email protected]
Contact person for scientific queries
Name 3652 0
Homi Zargar
Address 3652 0
Urology department
Palmerston North Hospital
50 Ruahine Street
Private Bag 11036
Palmerston North 4442
New Zealand
Country 3652 0
New Zealand
Phone 3652 0
+64,6,3509169
Fax 3652 0
Email 3652 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.