Clinical trial NCT02679339: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute-onset Herpes Zoster Pain
Lead sponsor: Centrexion Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-02-10
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To evaluate the safety of topically applied 40% lidocaine gel measuring incidence, intensity, relationship, and seriousness of treatment-emergent AEs
timeFrame: 28 days
measure: To evaluate the pharmacokinetics of topically applied 40% lidocaine gel measuring Tmax
timeFrame: 28 days
Secondary outcomes:
measure: To assess the effect of 40% lidocaine gel on 0-10 numeric pain rating scale (NPRS) scores related to acute herpes zoster
timeFrame: 28 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
affiliation: Nucleus Network Melbourne, Australia
name: Michael Araco, MD
role: PRINCIPAL_INVESTIGATOR
References: