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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02679339




Registration number
NCT02679339
Ethics application status
Date submitted
9/02/2015
Date registered
10/02/2016
Date last updated
10/02/2016

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] 0 0
2022-HZ-011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute-onset Herpes Zoster Pain 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: CNTX-2022 (lidocaine gel, 40%) - Application of 1mL CTNX-2022 (40% Anhydrous Lidocaine Gel) topically applied to 300cm squared outlined area once daily (in the morning) for 8 days at the study site.

Placebo comparator: Placebo - Application of 1mL placebo topically applied to 300cm squared outlined area once daily (in the morning) for 8 days at the study site.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety of topically applied 40% lidocaine gel measuring incidence, intensity, relationship, and seriousness of treatment-emergent AEs
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
To evaluate the pharmacokinetics of topically applied 40% lidocaine gel measuring Tmax
Timepoint [2] 0 0
28 days
Secondary outcome [1] 0 0
To assess the effect of 40% lidocaine gel on 0-10 numeric pain rating scale (NPRS) scores related to acute herpes zoster
Timepoint [1] 0 0
28 days

Eligibility
Key inclusion criteria
1. Subject is a male or female = 18 years of age and = 85 years of age.
2. Subject has brush-evoked allodynic pain intensity score = 4 using the NPRS as determined by pain assessment during the physical examination at screening.

a. Onset must have occurred = 20 days prior to randomization
3. Subject has an average daily pain intensity score of = 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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2015
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Centrexion Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study 2022-HZ-011 will utilize 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
https://clinicaltrials.gov/study/NCT02679339
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Araco, MD
Address 0 0
Nucleus Network Melbourne, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02679339