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

NCT ID: NCT02679339

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-08-31

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.

Conditions

Acute-onset Herpes Zoster Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

CNTX-2022 (lidocaine gel, 40%)

Intervention Type: DRUG

Placebo

Application of 1mL placebo topically applied to 300cm squared outlined area once daily (in the morning) for 8 days at the study site.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

CNTX-2022 (lidocaine gel, 40%)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centrexion Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Araco, MD

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network Melbourne, Australia

Locations

Nucleus Network

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

2022-HZ-011

Identifier Type: -

Identifier Source: org_study_id