Study to Evaluate the Safety and Pharmacokinetics of Topically Applied 40% Lidocaine Gel Compared with Placebo in Subjects With Acute Herpes Zoster (Shingles) Pain

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000033549
• Date of registration: 19/01/2015
• Prospective Registration: No
• Primary sponsor: Centrexion Corporation
• 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
• Date of first enrolment: 11/12/2014
• Target sample size: 16
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000033549.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial;

Countries of recruitment

Australia

Contacts

• Name: Ms Lydia Dyett

• Name: Dr Rob Allen, MD

Key inclusion & exclusion criteria

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.
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.


Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Pain management

Acute Herpes Zoster (Shingles) Pain;Herpes Zoster (Shingles);
Acute Herpes Zoster (Shingles) Pain
Herpes Zoster (Shingles)

Infection - Other infectious diseases

Skin - Dermatological conditions

Intervention(s)

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.

Primary Outcome(s)

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)
[Days 1-12 and Day 28]

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
[Days 1-12 and Day 28]

Secondary Outcome(s)

To assess the effect of 40% lidocaine gel on 0-10 numeric pain rating scale (NPRS) pain scores related to acute herpes zoster. [Days 1-12 and Day 28]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Centrexion Corporation

Ethics review

Status: Approved
Approval date:
Contact:

Alfred Hospital Ethics Committee