Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000485831
Ethics application status
Approved
Date submitted
1/05/2012
Date registered
2/05/2012
Date last updated
2/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Two-Part Study to Evaluate the Pharmacokinetics and Safety of a 7-Day Tamsulosin Transdermal Delivery System (TDS) in Healthy Male Volunteers
Scientific title
A Phase 1 Two-Part Study to Evaluate the Pharmacokinetics and Safety of a 7-Day Tamsulosin Transdermal Delivery System (TDS) in Healthy Male Volunteers
Secondary ID [1] 280421 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
benign prostatic hyperplasia 286389 0
Condition category
Condition code
Renal and Urogenital 286639 286639 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
7 day wearing of a Tamsulosin Transdermal Delivery System designed to deliver drug continuously for 7 days. The delivery rate is estimated to be 0.4 mg/day.
Intervention code [1] 284776 0
Treatment: Drugs
Comparator / control treatment
A single dose of tamsulosin 0.4 mg capsule will be administered followed by a 3-day washout prior to treatment with tamsulosin TDS
Control group
Active

Outcomes
Primary outcome [1] 287041 0
plasma concentrations of tamsulosin
Timepoint [1] 287041 0
6,12,18,24,30,36,48,60,72,84,96,108,120,132,144,156,168,172,180,192,216,240 hours after TDS application
Secondary outcome [1] 297259 0
Safety and local tolerability following TDS application
Timepoint [1] 297259 0
hourly vital signs through 12 hours after TDS application and then every 4-6 hours until removal. Skin sites assessed for irritation 4,12,24,48 hours after TDS removal
Secondary outcome [2] 297279 0
safety following oral tamsulosin administration
Timepoint [2] 297279 0
hourly vital signs after tamsulosin capsule dosing throgh 12 hours, and then every 4-6 hours through 60 hours post-dose

Eligibility
Key inclusion criteria
healthy male volunteers aged 18-40
normal findings in ECG and physical exam
normal clinical laboratory values
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
allergy or intolerance to tamsulosin
orthostatic hypotension
history of alcohol or drug abuse
prescription or OTC drug use in 2 weeks prior to screening
hemoglobin less than 130 gm/mL

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
19
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285177 0
Commercial sector/Industry
Name [1] 285177 0
Corium International, Inc.
Country [1] 285177 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Corium International, Inc.
Address
235 Constitution Drive
Menlo Park, CA 94025
Country
United States of America
Secondary sponsor category [1] 284045 0
None
Name [1] 284045 0
Address [1] 284045 0
Country [1] 284045 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287188 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 287188 0
55 Commercial Road
Melbourne, VIC 3004
Ethics committee country [1] 287188 0
Australia
Date submitted for ethics approval [1] 287188 0
Approval date [1] 287188 0
20/04/2012
Ethics approval number [1] 287188 0
EC00315

Summary
Brief summary
Tamsulosin is currently prescribed for the symptoms associated with a condition known as benign prostatic hyperplasia. In lay terms this is known as an enlarged prostate (benign). This condition is common in men over the age of 70. The condition can become symptomatic (meaning that symptoms appear) with urinary tract infections and signs of obstruction (of the urine pathway) reported. Symptoms are reported in about 10-30% of men aged in the early 70s.
Tamsulosin is currently prescribed for these symptoms. An oral capsule containing tamsulosin has been approved in Australia and other countries and has been on the Australian market for several years. The tablet is taken daily by patients. The current study will test the safety and effectiveness of administering tamsulosin by an alternative method – a patch will be applied once to the skin and is designed to provide 7 days of doses. This patch is called a transdermal delivery system (TDS).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34123 0
Address 34123 0
Country 34123 0
Phone 34123 0
Fax 34123 0
Email 34123 0
Contact person for public queries
Name 17370 0
Christina Dickerson
Address 17370 0
235 Constitution Drive
Menlo Park, CA 94025
Country 17370 0
United States of America
Phone 17370 0
+1 650 2988255
Fax 17370 0
+1 650 2988012
Email 17370 0
Christina@coriumtech.com
Contact person for scientific queries
Name 8298 0
Bobby Singh
Address 8298 0
235 Constitution Drive
Menlo Park, CA 94025
Country 8298 0
United States of America
Phone 8298 0
+1 650 2988255
Fax 8298 0
+1 650 2988012
Email 8298 0
bobby@coriumtech.com

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.