Postherpetic NeuralgiaPhase 2NCT00916942
Study of NGX-4010 With the Use of Open Label Lidocaine (2.5%)/Prilocaine (2.5%) Cream for the Treatment of Postherpetic Neuralgia (PHN)
A Phase 2 study testing capsaicin 8% and Lidocaine (2.5%)/Prilocaine (2.5%) Cream in people with Postherpetic Neuralgia, run by NeurogesX at 6 sites in United States.
Trial summary
This study is an open-label multi-center to evaluate the tolerability of treatment with NGX-4010 use with pre-patch topical application of a topical anesthetic cream. This is an open-label study. No hypothesis testing will be performed. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- capsaicin 8% and Lidocaine (2.5%)/Prilocaine (2.5%) Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2009to Jul 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 90 years of age, inclusive.
- Be in good health.
- Prior diagnosis of PHN with pain persisting at least 3 months following shingles vesicle crusting.
- Pain due to PHN that, in the opinion of the investigator, is of appropriate severity for treatment with NGX-4010. The subject should have completed at least 3 NPRS scores.
- Intact, unbroken skin over the painful area(s) to be treated.
- Female subjects with child-bearing potential must have a negative serum beta hCG pregnancy test, to be performed at the Screening Visit.
Show all 9Show fewer
- All subjects must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study and for 30 days following study termination.
- Be willing and able to comply with protocol requirements for the duration of study participation. (Such requirements include, but are not limited to: attending all study visits, refraining from elective surgery or extensive travel during study participation.)
- Subjects must sign an informed consent form for this study approved by the IRB. -
Who cannot join
- Receipt of NGX-4010 open label or blinded study patches within 12 weeks of the Study Patch Application Visit (Day 0).
- Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose.
- Unavailability of an effective pain medication strategy for the subject, such as unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with oxycodone or other analgesic, as judged by the Investigator.
- Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse (including alcoholism) judged likely to recur during the study period by the investigator.
- Recent use (within 7 days preceding the Study Patch Application Visit [Day 0]) of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas.
- Current or use within the past 30 days of any investigational agent
Show all 21Show fewer
- Patients treated with class I (such as tocainide and mexiletine) or III anti-arrhythmic drugs.
- Significant pain of an etiology other than PHN, for example, compression-related neuropathies (e.g., spinal stenosis), fibromyalgia or arthritis. Subjects must not have significant ongoing pain from other cause(s) that may interfere with judging PHN related pain.
- Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
- Patients with congenital or idiopathic methemoglobinemia
- Patients with glucose-6-phosphate dehydrogenase deficiencies
- Uncontrolled (systolic blood pressure ≥ 175 mmHg or diastolic blood pressure ≥105 mmHg) or unstable hypertension
- Clinically significant cardiovascular disease defined as cerebrovascular accident, transient ischemic attack, myocardial infarction, unstable angina, stable angina, current arrhythmia, coronary artery disease, any heart surgery including coronary artery bypass graft surgery or percutaneous coronary angioplasty/stent placement, or valvular heart disease within the past 6 months
- Clinically significant abnormal ECG at screening.
- Clinically significant abnormal labs at screening.
- Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function.
- Active malignancy or past history of malignancy during the past 5 years (history of squamous cell carcinoma or basal cell carcinoma of the skin are exempted from the exclusion criteria except if they occurred in the area of treatment).
- Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
- Hypersensitivity to capsaicin (i.e., chili peppers or Over-the-Counter (OTC) capsaicin products), or any components of the capsaicin patch, Cleansing Gel, oxycodone, hydrocodone, or adhesives.
- Patients with a known history of sensitivity to local anesthetics (including lidocaine and prilocaine) of the amide type or to any other component of the product
- Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete daily pain diaries requiring recall of average pain level in the past 24 hours.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Clinical Trials of America, Inc.
Hickory, North Carolina, 28601
Drug Studies America
Marietta, Georgia, 30060
Anchor Research Center
Naples, Florida, 34102
Lifetree Clinical Research
Salt Lake City, Utah, 84106
A & A Pain Institute
St Louis, Missouri, 63141
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, 33702
About this study
Official title: An Open-Label Study Of The Use Of Topical Lidocaine (2.5%)/Prilocaine (2.5%) Cream As Pre-Treatment For NGX-4010 In Subjects With Postherpetic Neuralgia (PHN)
This study is an open-label multi-center to evaluate the tolerability of treatment with NGX-4010 use with pre-patch topical application of a topical anesthetic cream. This is an open-label study. No hypothesis testing will be performed.
Eligible subjects will have PHN and a level of pain at an intensity level deemed appropriate for open-label treatment with NGX-4010, as judged by the Investigator. Painful areas of up to a maximum of 1000 cm2 will be pre-treated with lidocaine (2.5%)/prilocaine (2.5%) cream for 60 minutes followed by a single, 60-minute application of NGX-4010. Subjects may be on chronic pain medication regimens, but currently will not be using any topical pain medications on the affected areas, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or capsaicin.
- Conditions
- Postherpetic Neuralgia
- Being tested
- capsaicin 8%, Lidocaine (2.5%)/Prilocaine (2.5%) Cream
- Keywords
- Tolerability study
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsaicin 8%Drug
High concentration capsaicin 8% dermal patch applied for one hour
Lidocaine (2.5%)/Prilocaine (2.5%) CreamDrug
Pre-treatment for NGX-4010
| Study group | Role | What they receive |
|---|---|---|
| NGX-4010 patch | Experimental | Not described Receives: Drug: capsaicin 8% |
| Lidocaine (2.5%)/Prilocaine (2.5%) Cream | Experimental | Pre-treatment for NGX-4010 Receives: Drug: Lidocaine (2.5%)/Prilocaine (2.5%) Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of patch application
Measured: Day of treatment
Secondary outcomes (1)
Mean change in NPRS scores from pre-treatment values to subsequent time points on the day of treatment
Measured: Day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeurogesX
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916942
- Sponsor's protocol ID
- C123
- Status last verified
- Sep 2009
- First submitted
- 8 Jun 2009
- Last updated
- 9 Sep 2009
- Results posted
- No
Publications
Webster LR, Nunez M, Tark MD, Dunteman ED, Lu B, Tobias JK, Vanhove GF. Tolerability of NGX-4010, a capsaicin 8% dermal patch, following pretreatment with lidocaine 2.5%/prilocaine 2.5% cream in patients with post-herpetic neuralgia. BMC Anesthesiol. 2011 Dec 19;11:25. doi: 10.1186/1471-2253-11-25.
PubMed 22182397
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Of The Use Of Topical Lidocaine (2.5%)/Prilocaine (2.5%) Cream As Pre-Treatment For NGX-4010 In Subjects With Postherpetic Neuralgia (PHN)
- ClinicalTrials.gov ID
- NCT00916942
- Acronym / sponsor ID
- C123
- Conditions
- Postherpetic Neuralgia
- Keywords
- Tolerability study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NeurogesXIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 10 Jun 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 study is an open-label multi-center to evaluate the tolerability of treatment with NGX-4010 use with pre-patch topical application of a topical anesthetic cream. This is an open-label study. No hypothesis testing will be performed.
Eligible subjects will have PHN and a level of pain at an intensity level deemed appropriate for open-label treatment with NGX-4010, as judged by the Investigator. Painful areas of up to a maximum of 1000 cm2 will be pre-treated with lidocaine (2.5%)/prilocaine (2.5%) cream for 60 minutes followed by a single, 60-minute application of NGX-4010. Subjects may be on chronic pain medication regimens, but currently will not be using any topical pain medications on the affected areas, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or capsaicin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NGX-4010 patch | Experimental | Drug: capsaicin 8% |
| Lidocaine (2.5%)/Prilocaine (2.5%) Cream | Experimental | Drug: Lidocaine (2.5%)/Prilocaine (2.5%) CreamPre-treatment for NGX-4010 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between 18 and 90 years of age, inclusive.
- Be in good health.
- Prior diagnosis of PHN with pain persisting at least 3 months following shingles vesicle crusting.
- Pain due to PHN that, in the opinion of the investigator, is of appropriate severity for treatment with NGX-4010. The subject should have completed at least 3 NPRS scores.
- Intact, unbroken skin over the painful area(s) to be treated.
Key exclusion criteria (21 listed)
- Receipt of NGX-4010 open label or blinded study patches within 12 weeks of the Study Patch Application Visit (Day 0).
- Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose.
- Unavailability of an effective pain medication strategy for the subject, such as unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with oxycodone or other analgesic, as judged by the Investigator.
- Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse (including alcoholism) judged likely to recur during the study period by the investigator.
- Recent use (within 7 days preceding the Study Patch Application Visit [Day 0]) of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas.
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 8%High concentration capsaicin 8% dermal patch applied for one hour | Drug | NGX-4010 patch |
| Lidocaine (2.5%)/Prilocaine (2.5%) CreamPre-treatment for NGX-4010 | Drug | Lidocaine (2.5%)/Prilocaine (2.5%) Cream |
Primary outcome
Duration of patch application
Time frame: Day of treatment
1 secondary outcome
Mean change in NPRS scores from pre-treatment values to subsequent time points on the day of treatment
Time frame: Day of treatment
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 9 Sep 2009.
- Derived from this study: PubMed 22182397Webster LR, Nunez M, Tark MD, Dunteman ED, Lu B, Tobias JK, Vanhove GF. Tolerability of NGX-4010, a capsaicin 8% dermal patch, following pretreatment with lidocaine 2.5%/prilocaine 2.5% cream in patients with post-herpetic neuralgia. BMC Anesthesiol. 2011 Dec 19;11:25. doi: 10.1186/1471-2253-11-25.
Related trials for Postherpetic Neuralgia
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 8% and Lidocaine (2.5%)/Prilocaine (2.5%) Cream in people with Postherpetic Neuralgia, run by NeurogesX at 6 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 9 inclusion and 21 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 9 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does the primary outcome measure?
Duration of patch application (time frame: Day of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00916942, which also lists 1 linked publication.
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 9 Sep 2009.