NeuralgiaPhase 2NCT00034710
Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain
A Phase 2 study testing Capsaicin Patch in people with Neuralgia and Pain, run by NeurogesX at 8 sites in United States.
Trial summary
The purpose of this study is to gain initial information on the tolerability of high-dose capsaicin patches in patients with Painful Postherpetic Neuralgia. The study will also collect preliminary information on safety and efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia, Pain, Peripheral Nervous System Diseases
- What is being tested?
- Capsaicin Patch
- How many people
- 42 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2002to Oct 2002
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Have a diagnosis of Painful Postherpetic Neuralgia and are at least 6 months post vesicle crusting.
- Are in good health.
- Have an adequate pain score during the screening period.
- Have painful areas (maximum of two sites) below the neck.
- If female, are of non-childbearing ability as defined by absence of menses for a minimum of 3 months or surgically sterile.
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- If male, are willing to agree to take adequate birth control precautions with their partner for 60 days following experimental drug exposure.
- Have unbroken skin with good perfusion over the painful area(s).
- Have the ability to feel capsaicin-mediated sensations, as evidenced by ability to feel topically applied OTC capsaicin cream.
- Are on a stable and continuous medication regimen, with no change in dosage for 21 days prior to study start, and are willing to maintain concomitant medications at current doses throughout the study.
- Are willing and able to use oral opioid-based analgesic agents for relief, in case this is needed to relieve acute pain associated with the application of capsaicin patches.
- Are 18 years of age or older.
- Are willing and able to comply with the protocol
Who cannot join
- Patients will not be eligible for this study if they:
- Have diffusely distributed neuropathic pain (i.e., pain that is evident in more than 2 different sites). Subjects must not have significant pain outside the areas to be treated.
- Have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
- Currently (within the past 21 days) use topically applied non-steroidal anti-inflammatory drugs, local anesthetics, steroids or capsaicin products on the painful areas.
- Currently (within the past 21 days) use topical agents such as lidoderm patch 5%, topical steroids or aspirin.
- Have a history or current problem with prescription drug or illicit substance abuse (from self report or as judged by investigator).
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- Currently have an abuse problem with alcohol (from self-report or as judged by investigator).
- Are suspected of psychosocial gain/benefit of continued pain as judged by the investigator or primary treating physician.
- Plan to travel more than 100 miles from home during the study or engage in unusual activities that might exacerbate pain.
- Have poor cardiac, renal, hepatic, or pulmonary function judged by the investigator or primary treating physician.
- Have a laboratory value at screening outside the normal range, unless it is judged by the investigator as not clinically significant after appropriate evaluation.
- Have hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, oral opioid-based analgesic agents, or adhesives.
- Have a high tolerance to opioids.
- Currently using Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Brigham and Women's Hospital, Pain Trials Center
Boston, Massachusetts, 02115
University of Wisconsin Hospital, Neurology Department
Madison, Wisconsin, 53792
Anchor Research Center
Naples, Florida, 34102
Palm Beach Neurological Center
Palm Beach Gardens, Florida, 33410
Arizona Research Center
Phoenix, Arizona, 85023
University of Utah Pain Management Center
Salt Lake City, Utah, 84108
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33701
University of Arizona Health Sciences Center
Tucson, Arizona, 85724
About this study
Official title: A Double-Blind Controlled Pilot Study of High-Dose Capsaicin Patches in the Treatment of Pain Associated With Postherpetic Neuralgia
The purpose of this study is to gain initial information on the tolerability of high-dose capsaicin patches in patients with Painful Postherpetic Neuralgia. The study will also collect preliminary information on safety and efficacy.
- Conditions
- Neuralgia, Pain, Peripheral Nervous System Diseases, Herpes Zoster
- Being tested
- Capsaicin Patch
- Keywords
- Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, Herpes Zoster/*complications/drug therapy, Neuralgia/*drug therapy/etiology, Pain, Capsicum, Pepper, Dermal assessment, Pain measurement, Diary, PHN, Postherpetic Neuralgia, allodynia, hyperalgesia, shingles, varicella
- Medical subject headings
- Neuralgia, Pain, Peripheral Nervous System Diseases, Herpes Zoster, Neuralgia, Postherpetic, Hyperalgesia, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin PatchDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2002 (estimated)
- Study startMar 2002
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Masking
- Double blind
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- NeurogesX
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John A Jermano, Study director, NeurogesX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034710
- Sponsor's protocol ID
- C102
- Status last verified
- Feb 2006
- First submitted
- 1 May 2002
- Last updated
- 7 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Controlled Pilot Study of High-Dose Capsaicin Patches in the Treatment of Pain Associated With Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT00034710
- Acronym / sponsor ID
- C102
- Conditions
- Neuralgia, Pain, Peripheral Nervous System Diseases, Herpes Zoster
- Keywords
- Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, Herpes Zoster/*complications/drug therapy, Neuralgia/*drug therapy/etiology, Pain, Capsicum, Pepper, Dermal assessment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- NeurogesXIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Study completion
- Oct 2002
- First posted
- 2 May 2002 (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.
The purpose of this study is to gain initial information on the tolerability of high-dose capsaicin patches in patients with Painful Postherpetic Neuralgia. The study will also collect preliminary information on safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Have a diagnosis of Painful Postherpetic Neuralgia and are at least 6 months post vesicle crusting.
- Are in good health.
- Have an adequate pain score during the screening period.
- Have painful areas (maximum of two sites) below the neck.
- If female, are of non-childbearing ability as defined by absence of menses for a minimum of 3 months or surgically sterile.
Key exclusion criteria (14 listed)
- Have diffusely distributed neuropathic pain (i.e., pain that is evident in more than 2 different sites). Subjects must not have significant pain outside the areas to be treated.
- Have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
- Currently (within the past 21 days) use topically applied non-steroidal anti-inflammatory drugs, local anesthetics, steroids or capsaicin products on the painful areas.
- Currently (within the past 21 days) use topical agents such as lidoderm patch 5%, topical steroids or aspirin.
- Have a history or current problem with prescription drug or illicit substance abuse (from self report or as judged by investigator).
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 |
|---|---|---|
| Capsaicin Patch | Drug | – |
Primary outcome
Not reported in the source record.
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 7 Feb 2006.
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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.
John A Jermano study director
NeurogesX
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capsaicin Patch in people with Neuralgia and Pain, run by NeurogesX at 8 sites in United States.
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 13 inclusion and 14 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 7 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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.
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 7 Feb 2006.