Evaluation of Civamide Patch in Treatment of Postherpetic Neuralgia and Post-Incisional Neuralgia

February 9, 2017 updated by: Winston Laboratories

Phase II Proof of Concept Trial of Civamide Patch in the Treatment of Post-herpetic Neuralgia and Post-incisional Neuralgia

This proof of concept study is designed to evaluate the safety and efficacy of topically administered Civamide Patch for the treatment of moderate to severe daily pain associated with postherpetic neuralgia localized to the trunk, and with localized post-incisional neuropathic pain syndromes on the trunk.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There will be up to approximately 20 evaluable subjects in this open-label study. The study is composed of a 1-week non-treatment Baseline Period (Day -7 to -1), during which subjects will be required to complete a Daily Diary assessing overall pain and sleep interference. The 1-week Baseline Period will be followed by a 4-week Treatment Period, in which subjects will apply the Civamide Patch (0.015%) daily 12 hours per day, for a period of 4 weeks, complete a Daily Diary assessing overall pain and sleep interference, followed by a 2-week Post-Treatment Observation Period. In the course of the study, subjects will visit the clinic a total of five times for physical examinations, vital signs, review of diaries, and distribution and collection of test patches. Efficacy assessment will be the mean change from Baseline Period in efficacy variables during the course of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Etobicoke, Ontario, Canada, M9V 4B8
        • U.T. Pain Specialist
  • United States
    • Florida
      • Sunrise, Florida, United States, 33351
        • Neurology Clinical Research, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Pain and Rehabilitationi Clinic of Chicago
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head-Pain and Neurological Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject healthy other than history of postherpetic neuralgia of at least 6 months after healing of a herpes zoster skin rash.
  • Subject must be taking a stable dose of a medication(s) for PHN pain, and be expected to remain on this stable daily dose throughout the study.
  • Single, localized area of skin on trunk with PHN, measuring approximately 10 x 14 cm or less.
  • Average Daily Pain Score of 4 or higher on 11-point Likert scale during the 7-Day Baseline Period.
  • Males or females between 18 to 80 years of age, inclusive.
  • Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control throughout study or females of non-childbearing potential. Negative urine pregnancy test must be confirmed at Screening.
  • Subject agrees not to begin any new concomitant medications during study.

Exclusion Criteria:

  • Subject has area of skin on trunk affected by PHN, greater than an area amendable to treatment by the patch, or exhibits active skin disease, infection, severe erythema, or other compromise in integrity of skin which, could influence or interfere with the evaluation of safety or efficacy.
  • Subject has history of frequent headache or other painful conditions (other than that associated with PHN), expected to require more than twice a week additional administration of OTC acetaminophen (≤ 1000 mg total daily dose for pain management).
  • Clinical, historical or previous laboratory evidence of significant cardiovascular, renal, gastrointestinal, pulmonary, hepatic, endocrine, neurological, psychological, or other systemic disease that might confound the results of study or pose an additional risk to subject.
  • Subject is immunocompromised.
  • Use of any restricted medication within given time period prior to Baseline Period and throughout study (See Table 1).
  • Females who are pregnant, breast-feeding, or planning to become pregnant during study.
  • Subject has a history of alcohol and/or drug abuse within past year.
  • Subject has previously participated in a Civamide study.
  • Subject has participated in another investigational study, or taken another investigational drug within past 4 weeks.
  • Subject received neurolytic or neurosurgical therapy for this or previous episodes of postherpetic neuralgia.
  • Known hypersensitivity to or contraindication to use of Civamide (zucapsaicin), capsaicin (Zostrix®, Zostrix-HP®, Axsain®, or related products) or to excipients of clinical formulation.
  • If, for any other reason the subject is not deemed to be suitable by Investigator, they should not be enrolled.
  • Initiation of a medication, discontinuation of a medication or change in regimen of existing medication(s) or therapies less than required period of stable dosing prior to entering Baseline Period.
  • Topical use of any moisturizer or similar products on or near treatment area within 48 hours of Day 1 until after completion of Study on Day 43.
  • Topical use of any capsaicin-containing product for 60 days prior to Day 1 until after completion of Study on Day 43.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Civamide Patch 0.015%
All subjects in study will receive the Civamide Patch 0.015%
Drug: Civamide Patch
Patch containing Civamide (zucapsaicin) 0.015%, containing 0.210 mg Civamide per patch, applied once a day for four weeks.
Other Names:
  • zucapsaicin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Average Daily Pain Score from the Baseline Period to the Average Daily Pain Score of the last week of the Treatment Period.
Time Frame: Day 29 and Day 43
Day 29 and Day 43

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Average Daily Sleep Score
Time Frame: Change from baseline to other weeks in study
Change from baseline to other weeks in study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Winston Laboratories

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Scott Phillips, M.D., Winston Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WL-1001-04-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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