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

Acute-onset Herpes Zoster Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02679339
• Other study ID #: 2022-HZ-011
• Status: Terminated
• Phase: Phase 1
• First received: February 9, 2015
• Last updated: February 9, 2016
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Centrexion Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute-onset Herpes Zoster Pain
• Herpes Zoster

Intervention

Drug:
• CNTX-2022 (lidocaine gel, 40%)

• Placebo

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Centrexion Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety of topically applied 40% lidocaine gel measuring incidence, intensity, relationship, and seriousness of treatment-emergent AEs		28 days	Yes
Primary	To evaluate the pharmacokinetics of topically applied 40% lidocaine gel measuring Tmax		28 days	No
Secondary	To assess the effect of 40% lidocaine gel on 0-10 numeric pain rating scale (NPRS) scores related to acute herpes zoster		28 days	No