Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000143022
Ethics application status
Approved
Date submitted
8/02/2010
Date registered
12/02/2010
Date last updated
12/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ascending dose of 40 % Lidocaine Gel applied to patients with Postherpetic Neuralgia.
Scientific title
A Phase I/II Pilot Single Ascending Dose, Randomized, Double Blind, Placebo Controlled Study to Evaluate Two Topically Applied 40% Lidocaine Gel Formulations in Patients With Postherpetic Neuralgia (Protocol Number: LID-001)
Secondary ID [1] 1400 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Herpes Zoster (shingle) 256778 0
Condition category
Condition code
Infection 256924 256924 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ascending dose of 40% Lidocaine gel in two formulations.
Cohort 1a and 1b will receive one dose of 0.125 ml of gel applied by hand to the skin
Cohort 2a and 2b will recieve one dose of 0.250 mlof gel applied by hand.
Cohort 3a and 3b will recieve one dose of 0.500 ml of gel applied by hand.
Intervention code [1] 255984 0
Treatment: Drugs
Comparator / control treatment
Placebo gel. This Gel is similar to the active formulation however the active component is removed.
Control group
Placebo

Outcomes
Primary outcome [1] 257800 0
Safety and Tolerabilty of two formulations of 40% Lidocaine gel at 0.125ml 0.250ml and 0.500 ml will be assesed on the basis of adverse events reported, vital signs and patient quesitonaire.
The potential adverse events expected in this study are: burning, swelling, redness, irratation, bruising of the skin. These site reaction are generally mild and resolve without treatment with in a few minutes to hours.
Timepoint [1] 257800 0
Patients will be continuously monitered while they are on the study.
Secondary outcome [1] 263214 0
To asses the affect of two formulations of 40% Lidocaine gel.
Timepoint [1] 263214 0
Patients will be asked to rate there pain intensity at 30 minutes, 1,2,4,6,8,12,16 and 24 hours post dose. The patients will do this by answering a qustionnaire.
Patients will also have a brush evoked pain assesment performed at 1,2,4,8,12,24 hours post dose. This assesment is performed by a doctor using a study specifc brush

Eligibility
Key inclusion criteria
Male or Female patients with a diagnosis of Herpes Zoster (shingles) with Posthepetic Neuralgia.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any significant unstable medical condition, allergic reaction or hypersensitivity to Lidocaine.

Study design
Purpose of the study
Treatment
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
Recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256487 0
Commercial sector/Industry
Name [1] 256487 0
Arcion Therapeutics, Inc
Country [1] 256487 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Nucleus Network
Address
Level 5, AMREP Precinct
89 Commercail Road,
Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 255799 0
None
Name [1] 255799 0
Address [1] 255799 0
Country [1] 255799 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258537 0
The Alfred Research and Ethcis Unit
Ethics committee address [1] 258537 0
Ethics committee country [1] 258537 0
Australia
Date submitted for ethics approval [1] 258537 0
Approval date [1] 258537 0
23/12/2009
Ethics approval number [1] 258537 0
1/09/0452

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30815 0
Address 30815 0
Country 30815 0
Phone 30815 0
Fax 30815 0
Email 30815 0
Contact person for public queries
Name 14062 0
Mary Franich
Address 14062 0
Centre for Clinical Studies.
5th Floor Burnet Tower, AMREP Precinct, 89 Commercail Road, Melbourne, Victoria, 3004
Country 14062 0
Australia
Phone 14062 0
1800 243 733
Fax 14062 0
61 3 90768911
Email 14062 0
contactus@centreforclinicalstudies.com.au
Contact person for scientific queries
Name 4990 0
Associoate Prof Peter Hodsman
Address 4990 0
Centre for Clinical Studies.
5th Floor Burnet Tower, AMREP Precinct, 89 Commercail Road, Melbourne, Victoria, 3004
Country 4990 0
Australia
Phone 4990 0
61 3 90768900
Fax 4990 0
61 3 90768911
Email 4990 0
p.hodsman@nucleusnetwork.com.au

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.