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
Sponsored by
About this trial
This is an interventional treatment trial for Acute-onset Herpes Zoster Pain
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.
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
No
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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