PainPhase 1NCT00912262
A Study to Investigate the Tolerability and Effects on Epidermal Nerve Fiber Density of Multiple Low-Concentrations of NGX-1998 in Healthy Volunteers
A Phase 1 study testing Capsaicin Topical Liquid in people with Pain, run by NeurogesX at 1 site in United States.
Trial summary
The purpose of this single-blinded study in healthy volunteers is to select a Low-Concentration Capsaicin Topical Liquid (LC-CTL) to serve as a control formulation in the further clinical development of Capsaicin Topical Liquid, NGX-1998 (10% w/w). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Capsaicin Topical Liquid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Nov 2008
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be included in the study, subjects must meet all of the Inclusion Criteria:
- 18 to 40 years of age, inclusive. Male and female subjects.
- Be in good health
- Have intact, unscarred skin over the thighs
- Agree not to use topically-applied products containing non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics, steroids or capsaicin anywhere on the thighs for the duration of the study
- Female subjects of child bearing potential must not be breast-feeding and must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test performed within 7 days prior to the Application Visit (Day 0)
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- All subjects, including early terminations, 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 experimental drug exposure
- Subjects must be willing and able to comply with protocol requirements for the duration of study participation. Requirements include but are not limited to attending all study visits and refraining from extensive travel during study participation
- Subjects must sign an informed consent form that has been approved by the Investigator's Institutional Review Board (IRB) to participate in this study
Who cannot join
- Any dermatological condition(s) that in the judgment of the Principal Investigator has the potential to disrupt skin integrity, healing, or alter sensory function on the thighs.
- Any skin infection, skin irritation (e.g., poison oak), history of eczema, trauma or burn (including sunburn) on the thighs within 30 days preceding the Application Visit (Day 0).
- Any medical history of painful conditions, surgery, or injury involving or affecting the thighs, including but not limited to prior orthopedic surgery, lumbosacral disc disease, sciatica, and hip or femur fracture.
- Any medical history of known or suspected body system abnormalities, including but not limited to diabetes, hypothyroidism, asthma or any form of peripheral or central nervous system disease.
- Subjects with congenital, idiopathic, or drug-induced methemoglobinemia.
- Use of any systemic medications that interact with the peripheral nervous system, including beta adrenergic blockers, alpha adrenergic blockers, anticonvulsant drugs, antidepressant drugs or opioids within 30 days prior to the Application Visit (Day 0).
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- Current use of any class III anti-arrhythmic drugs (eg, amiodarone, bretylium, sotalol, dofetilide).
- Use of any topically-applied product, including prescription or over the-counter (OTC) analgesic creams/lotions/patches, non steroidal anti-inflammatory drugs, counterirritants, local anesthetics, steroids or capsaicin on the thighs within 30 days preceding the Application Visit (Day 0).
- Currently taking any prescription medication except for oral, transdermal or injected contraceptives.
- Requirement for ongoing or periodic pain medication for any chronic or recurrent medical condition. Refer to Section 3.4 for additional information about concomitant medications.
- Participation in another drug research study within 30 days preceding the Application Visit (Day 0).
- Diagnosis of human immunodeficiency virus (HIV) infection, according to medical history and/or self-report; or Positive test result on the HIV-1 blood test performed at the Screening Visit (ICMA with Western Blot confirmation).
- History or current substance abuse including alcoholism/alcohol abuse.
- Positive test result on the urine drug screen for barbiturates, benzodiazepines, tricyclic anti-depressants, propoxyphene, opioids, cannabis, phencyclidine (PCP), cocaine and amphetamines performed at the Screening Visit.
- History of hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics (including lidocaine and prilocaine) or any components of the Capsaicin Topical Liquids, Cleansing Gel or the lidocaine 2.5% / prilocaine 2.5% topical anesthetic cream.
- Any clinically-significant abnormal laboratory test at the Screening Visit.
- Clinically-significant abnormal 12-Lead ECG at the Screening Visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Lifetree Clinical Research
Salt Lake City, Utah, 84106
About this study
Official title: A Randomized, Single Blind Study to Investigate the Tolerability and Effects on Epidermal Nerve Fiber Density of Multiple Low-Concentrations of Capsaicin Topical Liquid NGX-1998 in Healthy Volunteers
The purpose of this single-blinded study in healthy volunteers is to select a Low-Concentration Capsaicin Topical Liquid (LC-CTL) to serve as a control formulation in the further clinical development of Capsaicin Topical Liquid, NGX-1998 (10% w/w). The goal is to identify a low concentration formulation that will not reduce ENFD in healthy normal volunteers when compared to NGX-1998 (10% w/w) but would still produce some local capsaicin-related application site responses (e.g. erythema, heat sensation or pain) when applied.
Read the detailed description
This is a randomized, single center, single-blind controlled study in up to 36 healthy volunteers. Each subject will be dosed at four application sites, 7 by 7 cm in size, located n the distal and proximal anterior medial thigh areas. At two sites, subjects will receive 15-minute treatments of a LC-CTL (1%, 0.3%, 0.1%, 0.003% or 0.001% w/w). At the remaining two sites, subjects will receive 15-minute treatments of NGX-1998 (10% w/w) and a control liquid (CTL-V (0%)). The volume applied at each application site is estimated to be 7 mcl per cm2 and hence the total volume of approximately 300 mcl of LC-CTL (all concentrations), NGX-1998 (10% w/w) and CTL-V (0%) applied at each site application will be sufficient to evenly wet the surface.
The top or bottom section of each application site will be pre-treated with lidocaine 2.5% / prilocaine 2.5% topical anesthetic cream. These sections are also the sections where the skin punch biopsies will be taken. The biopsy will be obtained from these sections as it is anticipated that subsequent clinical trials in patients will use pre-treatment with a topical anesthetic. However, only the toop or bottom sections will be pre-treated with this topical anesthetic so that pre-treatment with the topical anesthetic cream does not interfere with tolerability assessments.
The pharmacodynamic effects of nerve fiber density and function will be evaluated by immunohistochemical staining of biopsied tissue from the treatment area. Skin punch biopsies at all four application sites will be obtained to evaluate ENFD at 7 days post-application.
Safety and tolerability will be evaluated by continuous monitoring of adverse events (AEs0 and periodic assessments of clinical laboratory parameters, vital signs, physical examinations, dermal assessments, and pain associated with treatment.
- Conditions
- Pain
- Being tested
- Capsaicin Topical Liquid
- Keywords
- Analgesics, Capsaicin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin Topical LiquidDrug
| Study group | Role | What they receive |
|---|---|---|
| Low and High Concentration Capsaicin Topical Liquids | Active comparator | Not described Receives: Drug: Capsaicin Topical Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the potential differences in the effects of 15-minute treatments of several Low-Concentration Capsaicin Topical Liquids, compared to 15-minute treatments of NGX-1998 and a control, Capsaicin Topical Liquid Vehicle, as quantified by Protein Gene
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startJun 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeurogesX
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeff Tobias, MD, Study director, NeurogesX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912262
- Sponsor's protocol ID
- C203
- Status last verified
- Jun 2009
- First submitted
- 2 Jun 2009
- Last updated
- 3 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Blind Study to Investigate the Tolerability and Effects on Epidermal Nerve Fiber Density of Multiple Low-Concentrations of Capsaicin Topical Liquid NGX-1998 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00912262
- Acronym / sponsor ID
- C203
- Conditions
- Pain
- Keywords
- Analgesics, Capsaicin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- NeurogesXIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Study completion
- Nov 2008
- First posted
- 3 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.
The purpose of this single-blinded study in healthy volunteers is to select a Low-Concentration Capsaicin Topical Liquid (LC-CTL) to serve as a control formulation in the further clinical development of Capsaicin Topical Liquid, NGX-1998 (10% w/w). The goal is to identify a low concentration formulation that will not reduce ENFD in healthy normal volunteers when compared to NGX-1998 (10% w/w) but would still produce some local capsaicin-related application site responses (e.g. erythema, heat sensation or pain) when applied.
Detailed description
This is a randomized, single center, single-blind controlled study in up to 36 healthy volunteers. Each subject will be dosed at four application sites, 7 by 7 cm in size, located n the distal and proximal anterior medial thigh areas. At two sites, subjects will receive 15-minute treatments of a LC-CTL (1%, 0.3%, 0.1%, 0.003% or 0.001% w/w). At the remaining two sites, subjects will receive 15-minute treatments of NGX-1998 (10% w/w) and a control liquid (CTL-V (0%)). The volume applied at each application site is estimated to be 7 mcl per cm2 and hence the total volume of approximately 300 mcl of LC-CTL (all concentrations), NGX-1998 (10% w/w) and CTL-V (0%) applied at each site application will be sufficient to evenly wet the surface.
The top or bottom section of each application site will be pre-treated with lidocaine 2.5% / prilocaine 2.5% topical anesthetic cream. These sections are also the sections where the skin punch biopsies will be taken. The biopsy will be obtained from these sections as it is anticipated that subsequent clinical trials in patients will use pre-treatment with a topical anesthetic. However, only the toop or bottom sections will be pre-treated with this topical anesthetic so that pre-treatment with the topical anesthetic cream does not interfere with tolerability assessments.
The pharmacodynamic effects of nerve fiber density and function will be evaluated by immunohistochemical staining of biopsied tissue from the treatment area. Skin punch biopsies at all four application sites will be obtained to evaluate ENFD at 7 days post-application.
Safety and tolerability will be evaluated by continuous monitoring of adverse events (AEs0 and periodic assessments of clinical laboratory parameters, vital signs, physical examinations, dermal assessments, and pain associated with treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low and High Concentration Capsaicin Topical Liquids | Active comparator | Drug: Capsaicin Topical Liquid |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 18 to 40 years of age, inclusive. Male and female subjects.
- Be in good health
- Have intact, unscarred skin over the thighs
- Agree not to use topically-applied products containing non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics, steroids or capsaicin anywhere on the thighs for the duration of the study
- Female subjects of child bearing potential must not be breast-feeding and must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test performed within 7 days prior to the Application Visit (Day 0)
Key exclusion criteria (17 listed)
- Any dermatological condition(s) that in the judgment of the Principal Investigator has the potential to disrupt skin integrity, healing, or alter sensory function on the thighs.
- Any skin infection, skin irritation (e.g., poison oak), history of eczema, trauma or burn (including sunburn) on the thighs within 30 days preceding the Application Visit (Day 0).
- Any medical history of painful conditions, surgery, or injury involving or affecting the thighs, including but not limited to prior orthopedic surgery, lumbosacral disc disease, sciatica, and hip or femur fracture.
- Any medical history of known or suspected body system abnormalities, including but not limited to diabetes, hypothyroidism, asthma or any form of peripheral or central nervous system disease.
- Subjects with congenital, idiopathic, or drug-induced methemoglobinemia.
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 Topical Liquid | Drug | Low and High Concentration Capsaicin Topical Liquids |
Primary outcome
To assess the potential differences in the effects of 15-minute treatments of several Low-Concentration Capsaicin Topical Liquids, compared to 15-minute treatments of NGX-1998 and a control, Capsaicin Topical Liquid Vehicle, as quantified by Protein Gene
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 3 Jun 2009.
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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.
Jeff Tobias, MD study director
NeurogesX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Capsaicin Topical Liquid in people with Pain, run by NeurogesX at 1 site 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 17 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 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To assess the potential differences in the effects of 15-minute treatments of several Low-Concentration Capsaicin Topical Liquids, compared to 15-minute treatments of NGX-1998 and a control, Capsaicin Topical Liquid Vehicle, as quantified by Protein Gene. 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 3 Jun 2009.