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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679339
Recruitment Status : Terminated (Limited patient enrollment)
First Posted : February 10, 2016
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Centrexion Therapeutics

Tracking Information
First Submitted Date  ICMJE February 9, 2015
First Posted Date  ICMJE February 10, 2016
Last Update Posted Date February 10, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
  • To evaluate the safety of topically applied 40% lidocaine gel measuring incidence, intensity, relationship, and seriousness of treatment-emergent AEs [ Time Frame: 28 days ]
  • To evaluate the pharmacokinetics of topically applied 40% lidocaine gel measuring Tmax [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute-onset Herpes Zoster Pain
Intervention  ICMJE
  • Drug: CNTX-2022 (lidocaine gel, 40%)
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: CNTX-2022 (lidocaine gel, 40%)
  • Placebo Comparator: Placebo
    Application of 1mL placebo topically applied to 300cm squared outlined area once daily (in the morning) for 8 days at the study site.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 9, 2016)
1
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02679339
Other Study ID Numbers  ICMJE 2022-HZ-011
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centrexion Therapeutics
Study Sponsor  ICMJE Centrexion Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Araco, MD Nucleus Network, Melbourne Australia
PRS Account Centrexion Therapeutics
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP