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

Primary Purpose

Acute-onset Herpes Zoster Pain

Status

Terminated

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

CNTX-2022 (lidocaine gel, 40%)

Placebo

About this trial

This is an interventional treatment trial for Acute-onset Herpes Zoster Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is a male or female ≥ 18 years of age and ≤ 85 years of age.
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
Subject has an average daily pain intensity score of ≥ 4 using the NPRS as determined by pain assessment during the physical examination at screening.
Subject must have a diagnosis of herpes zoster (shingles).
Subject has rash limited to trunk and limbs, with a total surface area of up to 300 cm2.

Exclusion Criteria:

Subject has an active herpes zoster lesion on the face, head, neck, genital or rectal areas.
Subject has rash limited to trunk and limbs, with a total surface area greater than 300 cm2.
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.
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.
Subject has any other form of pain that was not discernible from herpes zoster (shingles) allodynia.
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.

Sites / Locations

Nucleus Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CNTX-2022 (lidocaine gel, 40%)

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

To evaluate the safety of topically applied 40% lidocaine gel measuring incidence, intensity, relationship, and seriousness of treatment-emergent AEs

To evaluate the pharmacokinetics of topically applied 40% lidocaine gel measuring Tmax

Secondary Outcome Measures

To assess the effect of 40% lidocaine gel on 0-10 numeric pain rating scale (NPRS) scores related to acute herpes zoster

Full Information

NCT ID

NCT02679339

First Posted

February 9, 2015

Last Updated

February 9, 2016

Sponsor

Centrexion Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT02679339

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Terminated

Why Stopped

Limited patient enrollment

Study Start Date

January 2015 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centrexion Therapeutics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute-onset Herpes Zoster Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CNTX-2022 (lidocaine gel, 40%)

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CNTX-2022 (lidocaine gel, 40%)

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

To evaluate the safety of topically applied 40% lidocaine gel measuring incidence, intensity, relationship, and seriousness of treatment-emergent AEs

Time Frame

28 days

Title

To evaluate the pharmacokinetics of topically applied 40% lidocaine gel measuring Tmax

Time Frame

28 days

Secondary Outcome Measure Information:

Title

To assess the effect of 40% lidocaine gel on 0-10 numeric pain rating scale (NPRS) scores related to acute herpes zoster

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is a male or female ≥ 18 years of age and ≤ 85 years of age. 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 Subject has an average daily pain intensity score of ≥ 4 using the NPRS as determined by pain assessment during the physical examination at screening. Subject must have a diagnosis of herpes zoster (shingles). Subject has rash limited to trunk and limbs, with a total surface area of up to 300 cm2. Exclusion Criteria: Subject has an active herpes zoster lesion on the face, head, neck, genital or rectal areas. Subject has rash limited to trunk and limbs, with a total surface area greater than 300 cm2. 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. 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. Subject has any other form of pain that was not discernible from herpes zoster (shingles) allodynia. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Araco, MD

Organizational Affiliation

Nucleus Network Melbourne, Australia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nucleus Network

City

Melbourne

State/Province

Victoria

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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