Postherpetic NeuralgiaPhase 2NCT00845923
Evaluation of Civamide Patch in Treatment of Postherpetic Neuralgia and Post-Incisional Neuralgia
A Phase 2 study testing Civamide Patch in people with Postherpetic Neuralgia, run by Winston Laboratories at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- Civamide Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2009to Oct 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Michigan Head-Pain and Neurological Institute
Ann Arbor, Michigan, 48104
Pain and Rehabilitationi Clinic of Chicago
Chicago, Illinois, 60654
Neurology Clinical Research, Inc.
Sunrise, Florida, 33351
About this study
Official title: 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.
Read the 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.
- Conditions
- Postherpetic Neuralgia
- Being tested
- Civamide Patch
- Keywords
- Postherpetic neuralgia of at least 6 months
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Civamide PatchDrug
Also called zucapsaicin
Patch containing Civamide (zucapsaicin) 0.015%, containing 0.210 mg Civamide per patch, applied once a day for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Civamide Patch 0.015% | Other | All subjects in study will receive the Civamide Patch 0.015% Receives: Drug: Civamide Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Daily Pain Score from the Baseline Period to the Average Daily Pain Score of the last week of the Treatment Period.
Measured: Day 29 and Day 43
Secondary outcomes (1)
Average Daily Sleep Score
Measured: Change from baseline to other weeks in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winston Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Phillips, M.D., Study chair, Winston Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845923
- Sponsor's protocol ID
- WL-1001-04-03
- Status last verified
- Feb 2017
- First submitted
- 16 Feb 2009
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Proof of Concept Trial of Civamide Patch in the Treatment of Post-herpetic Neuralgia and Post-incisional Neuralgia
- ClinicalTrials.gov ID
- NCT00845923
- Acronym / sponsor ID
- WL-1001-04-03
- Conditions
- Postherpetic Neuralgia
- Keywords
- Postherpetic neuralgia of at least 6 months
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Winston LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Civamide Patch 0.015% | Other | Drug: Civamide PatchAll subjects in study will receive the Civamide Patch 0.015% |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Civamide PatchAlso: zucapsaicinPatch containing Civamide (zucapsaicin) 0.015%, containing 0.210 mg Civamide per patch, applied once a day for four weeks. | Drug | Civamide Patch 0.015% |
Primary outcome
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
1 secondary outcome
Average Daily Sleep Score
Time frame: Change from baseline to other weeks in study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Phillips, M.D. study chair
Winston Laboratories
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Civamide Patch in people with Postherpetic Neuralgia, run by Winston Laboratories at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.