Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000033549
Ethics application status
Approved
Date submitted
5/11/2014
Date registered
19/01/2015
Date last updated
19/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study to Evaluate the Safety and Pharmacokinetics of Topically Applied 40% Lidocaine Gel Compared with Placebo in Subjects With Acute Herpes Zoster (Shingles) Pain
Scientific title
A Phase Ib Pilot Multiple Dose, Randomized-Withdrawal, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacokinetics of Topically Applied 40% Lidocaine Gel Compared with Placebo in Subjects With Acute Herpes Zoster Pain
Secondary ID [1] 285540 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Herpes Zoster (Shingles) Pain 293358 0
Herpes Zoster (Shingles) 293366 0
Condition category
Condition code
Skin 293643 293643 0 0
Dermatological conditions
Infection 293789 293789 0 0
Other infectious diseases
Anaesthesiology 293790 293790 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application of 1mL CTNX-2022 (40% Anhydrous Lidocaine Gel) or placebo topically applied to 300cm squared outlined area once daily (in the morning) for 8 days at the study site.
Intervention code [1] 290486 0
Treatment: Drugs
Comparator / control treatment
Placebo gel
Control group
Placebo

Outcomes
Primary outcome [1] 293461 0
To evaluate the safety of topically applied 40% lidocaine gel by measuring by using descriptive statistics:
- Incidence, intensity, relationship, and seriousness of treatment-emergent AEs
- Treatment-emergent changes in vital signs, clinical laboratory tests, and ECGs
- Treatment-emergent changes at the application site (edema and erythema)
Timepoint [1] 293461 0
Days 1-12 and Day 28
Primary outcome [2] 293587 0
To evaluate the pharmacokinetics (PK) of topically applied 40% lidocaine gel by measuring:
- C(max)
- T(max)
- Elimination rate constant
- Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable plasma concentration
- Area under the plasma concentration-time curve from Time 0 to infinity
Timepoint [2] 293587 0
Days 1-12 and Day 28
Secondary outcome [1] 311101 0
To assess the effect of 40% lidocaine gel on 0-10 numeric pain rating scale (NPRS) pain scores related to acute herpes zoster.
Timepoint [1] 311101 0
Days 1-12 and Day 28

Eligibility
Key inclusion criteria
1. Subject is a male or female > or = 18 years of age and < or = 85 years of age.
2. Subject has brush-evoked allodynic pain intensity score > or = 4 using the NPRS as determined by pain assessment during the physical examination at screening.
a. Onset must have occurred < or = 20 days prior to randomization
3. Subject has an average daily pain intensity score of > or = 4 using the NPRS as determined by pain assessment during the physical examination at screening.
4. Subject must have a diagnosis of herpes zoster (shingles).
5. Subject has rash limited to trunk and limbs, with a total surface area of up to 300 cm2.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has an active herpes zoster lesion on the face, head, neck, genital or rectal areas.
2. Subject has rash limited to trunk and limbs, with a total surface area greater than 300 cm2.
3. Subject has a known history of allergic reaction, hypersensitivity, or clinically significant intolerance to lidocaine, ingredients of the study drug, or local anesthetics of the amide type.
4. Subject has target skin area (allodynic area and surrounding skin) that is not intact, is inflamed, or in the opinion of the Principal Investigator, consistent with rash due to acute herpes zoster.
5. Subject has any other form of pain that was not discernible from herpes zoster (shingles) allodynia.
6. Subject is taking Class I antiarrhythmic drugs (e.g., tocainide, mexiletine), or medications that could interact with the study drug or interfere with its evaluation.

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)
Upon returning to the clinic on the morning of Day 3, subjects will be randomized per the code provided prior to dosing. Stratified randomization will be used to achieve a reasonable balance of subjects with < or = 10 days and > 10 days since onset among the 4 treatment schedules. A randomization list will be computer-generated for each of the 2 strata using random permuted blocks.
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/12/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290152 0
Commercial sector/Industry
Name [1] 290152 0
Centrexion Corporation
Country [1] 290152 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Centrexion Corporation
Address
509 S. Exeter Street, Suite 202
Baltimore, MD 21202
Country
United States of America
Secondary sponsor category [1] 288862 0
None
Name [1] 288862 0
Address [1] 288862 0
Country [1] 288862 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291897 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 291897 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 291897 0
Australia
Date submitted for ethics approval [1] 291897 0
27/10/2014
Approval date [1] 291897 0
09/12/2014
Ethics approval number [1] 291897 0

Summary
Brief summary
A study utilizing a randomized withdrawal (RW), double-blind, placebo controlled design in which the PK and safety of CNTX 2022 (40% anhydrous lidocaine gel) will be evaluated in subjects with acute-onset herpes zoster pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52274 0
Dr Michael Araco, MD
Address 52274 0
Dr. Michael Araco, MD
Nucleus Network
5th Floor, Burnet Tower, AMREP Precinct
89 Commercial Road
Melbourne, Victoria, 3004
Country 52274 0
Australia
Phone 52274 0
+61 3 9076 8930
Fax 52274 0
Email 52274 0
m.araco@nucleusnetwork.com.au
Contact person for public queries
Name 52275 0
Ms Lydia Dyett
Address 52275 0
Lydia Dyett
Centrexion Corporation
509 S. Exeter Street, Suite 202
Baltimore, MD 21202
Country 52275 0
United States of America
Phone 52275 0
+1 (410) 522-8701 ext. 1108
Fax 52275 0
Email 52275 0
ldyett@centrexion.com
Contact person for scientific queries
Name 52276 0
Dr Rob Allen, MD
Address 52276 0
Dr. Rob Allen, MD
Centrexion Corporation
509 S. Exeter Street, Suite 202
Baltimore, MD 21202
Country 52276 0
United States of America
Phone 52276 0
+1 (410) 369-2208 (main)
Fax 52276 0
Email 52276 0
rallen@centrexion.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.