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

NCT02679339 | Terminated Phase 1

• 1 other identifier: 2022-HZ-011
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

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

  28 days

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

  28 days

Secondary Outcomes (1)

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

  28 days

Study Arms (2)

CNTX-2022 (lidocaine gel, 40%)

EXPERIMENTAL

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.

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CNTX-2022 (lidocaine gel, 40%) DRUG

CNTX-2022 (lidocaine gel, 40%)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centrexion Therapeutics: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, Australia

Location

Study Officials

• Michael Araco, MD

  Nucleus Network Melbourne, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 10, 2016
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

AU (1)