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

NCT00845923 | Completed Phase 2

• 1 other identifier: WL-1001-04-03
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Postherpetic Neuralgia

Keywords

Postherpetic neuralgia of at least 6 months

Outcome Measures

Primary Outcomes (1)

• Change in Average Daily Pain Score from the Baseline Period to the Average Daily Pain Score of the last week of the Treatment Period.

  Day 29 and Day 43

Secondary Outcomes (1)

• Average Daily Sleep Score

  Change from baseline to other weeks in study

Study Arms (1)

Civamide Patch 0.015%

OTHER

All subjects in study will receive the Civamide Patch 0.015%

Drug: Civamide Patch

Interventions

Civamide Patch DRUG

Patch containing Civamide (zucapsaicin) 0.015%, containing 0.210 mg Civamide per patch, applied once a day for four weeks.

Also known as: zucapsaicin

Civamide Patch 0.015%

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Winston Laboratories: lead

Study Sites (4)

Neurology Clinical Research, Inc.

Sunrise, Florida, 33351, United States

Location

Pain and Rehabilitationi Clinic of Chicago

Chicago, Illinois, 60654, United States

Location

Michigan Head-Pain and Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

U.T. Pain Specialist

Etobicoke, Ontario, M9V 4B8, Canada

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

zucapsaicin

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott Phillips, M.D.

  Winston Laboratories

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 13, 2017

Record last verified: 2017-02

Locations

US (3); CA (1)