HyperalgesiaPhase 1NCT01981395
Fenobam on Heat/Capsaicin Induced Hyperalgesia in Healthy Volunteers
A Phase 1 study testing Fenobam in people with Hyperalgesia and Allodynia, run by Laura Cavallone at 1 site in United States.
Trial summary
Our goal is to demonstrate that healthy volunteers treated with fenobam will develop a significantly reduced area of cutaneous hyperalgesia compared to volunteers treated with placebo, after exposure to the heat/capsaicin model of cutaneous sensitization. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperalgesia, Allodynia
- What is being tested?
- Fenobam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 year old
- Good general health with no remarkable medical conditions (e.g. liver, kidney, heart, or lung failure)
- BMI between 20-33
- Willing to comply with study guidelines as outlined in protocol [including: women of childbearing age must be willing to use a double-barrier method (e.g. oral contraception and condom) for contraception during participation in the study]
- Willing to provide informed consent
Who cannot join
- Anatomical malformation of upper extremities
- Status post recent trauma or chronic lesions on either forearm
- Medication use (includes vitamin, herbal, dietary and mineral supplements and grapefruit products during or within 14 days prior to study participation; excludes contraceptives)
- History of allergy or intolerance to capsaicin
- History of multiple drug allergies
- History of addiction to drugs or alcohol (prior or present addiction or treatment for addiction)
Show all 9Show fewer
- History of chronic pain syndromes
- Pregnant and nursing females
- Smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Double Blind, Randomized, Placebo Controlled, Crossover Study to Investigate the Anti-hyperalgesic Efficacy of a Single Dose of Fenobam on Heat/Capsaicin Induced Cutaneous Hyperalgesia in Adult Healthy Volunteers.
Our goal is to demonstrate that healthy volunteers treated with fenobam will develop a significantly reduced area of cutaneous hyperalgesia compared to volunteers treated with placebo, after exposure to the heat/capsaicin model of cutaneous sensitization. Additionally we are going to assess changes in mood/affect and cognitive function of subjects following administration of fenobam and after cutaneous sensitization compared to baseline.
Read the detailed description
All subjects will receive a topical dose of capsaicin cream 0.1%(Capzasin-HP) to the forearm at the start of the study visit. The order of the 2 treatment regimens indicated below will be randomized and blinded to subjects and researchers.
Treatment Regimen 1: Fenobam [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate]: administration of one 150 mg gelatin capsule.
Treatment Regimen 2: Placebo (lactose monohydrate): administration of one 150 mg gelatin capsule.
- Conditions
- Hyperalgesia, Allodynia
- Being tested
- Fenobam, Placebo
- Keywords
- fenobam, heat, capsaicin, hyperalgesia, allodynia, mood, cognitive function
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenobamDrug
Also called [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate]
Fenobam 150 mg will be administered and subjects will be monitored for up to 8 hours. During the study day questionnaires will be administered, blood will be drawn a testing site will be marked and pain testing and heat/capsaicin sensitization will be measured.
PlaceboDrug
Also called Lactose monohydrate
A placebo will be administered and subjects will be monitored for up to 8 hours. During the study day questionnaires will be administered, blood will be drawn a testing site will be marked and pain testing and heat/capsaicin sensitization will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Treatment regimn 1 | Experimental | 150 mg Fenobam Orally - once Receives: Drug: Fenobam |
| Treatment Regimen 2 | Placebo comparator | Placebo orally - once Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suppression of the development of cutaneous hyperalgesia and allodynia around the area treated with heat/capsaicin.
size of the area of hyperalgesia and allodynia around the area sensitized by heat/capsaicin as quantified by cutaneous stimulation with foam brush strokes and a von Frey filament requiring 26 g of bending force.
Measured: During approximately 7 hours of consecutive assessments
Secondary outcomes (5)
Evaluation of nociception after drug administration as evaluated by prolonged (1 min) thermal stimulation on normal (untreated) skin.
Visual Analog Scale (VAS) rating of pain perception at 1 min 45°C heat stimulation on normal skin.
Measured: During approximately 7 hours of consecutive assessments
Assessment of Heat Pain Detection Thresholds (HPDT) in normal and sensitized skin pre and post treatment with fenobam.
lowest temperature perceived as painful with stimulation starting at 32°C and with a safety cut-off at 52°C.
Measured: During approximately 7 hours of consecutive assessments
Absence of significant side effects
Determined by subjects' monitoring during treatment sessions and follow up at 1 day and 1 week after treatment with drug.
Measured: 7 days
Assessment of significant change in mood/affect
As determined by evaluation of the subjects by combined brief Positive And Negative Affect Scale/Brief State Anxiety Measure (PANAS/BSAM)
Measured: During approximately 6 hours of consecutive assessments
Assessment of significant change in cognitive function
As determined by evaluation of the Letter and Number Sequencing (LNS) assessment
Measured: During approximately 6 hours of consecutive assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperalgesiaStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laura Cavallone
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laura Cavallone, Washington University School of Medicine
- Investigators
- Laura F Cavallone, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981395
- Sponsor's protocol ID
- 201311094
- Status last verified
- Apr 2016
- First submitted
- 4 Nov 2013
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo Controlled, Crossover Study to Investigate the Anti-hyperalgesic Efficacy of a Single Dose of Fenobam on Heat/Capsaicin Induced Cutaneous Hyperalgesia in Adult Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01981395
- Acronym / sponsor ID
- 201311094
- Conditions
- Hyperalgesia, Allodynia
- Keywords
- fenobam, heat, capsaicin, hyperalgesia, allodynia, mood, cognitive function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Laura CavalloneUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Nov 2013 (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.
Our goal is to demonstrate that healthy volunteers treated with fenobam will develop a significantly reduced area of cutaneous hyperalgesia compared to volunteers treated with placebo, after exposure to the heat/capsaicin model of cutaneous sensitization. Additionally we are going to assess changes in mood/affect and cognitive function of subjects following administration of fenobam and after cutaneous sensitization compared to baseline.
Detailed description
All subjects will receive a topical dose of capsaicin cream 0.1%(Capzasin-HP) to the forearm at the start of the study visit. The order of the 2 treatment regimens indicated below will be randomized and blinded to subjects and researchers.
Treatment Regimen 1: Fenobam [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate]: administration of one 150 mg gelatin capsule.
Treatment Regimen 2: Placebo (lactose monohydrate): administration of one 150 mg gelatin capsule.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment regimn 1 | Experimental | Drug: Fenobam150 mg Fenobam Orally - once |
| Treatment Regimen 2 | Placebo comparator | Drug: PlaceboPlacebo orally - once |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-50 year old
- Good general health with no remarkable medical conditions (e.g. liver, kidney, heart, or lung failure)
- BMI between 20-33
- Willing to comply with study guidelines as outlined in protocol [including: women of childbearing age must be willing to use a double-barrier method (e.g. oral contraception and condom) for contraception during participation in the study]
- Willing to provide informed consent
Key exclusion criteria (9 listed)
- Anatomical malformation of upper extremities
- Status post recent trauma or chronic lesions on either forearm
- Medication use (includes vitamin, herbal, dietary and mineral supplements and grapefruit products during or within 14 days prior to study participation; excludes contraceptives)
- History of allergy or intolerance to capsaicin
- History of multiple drug allergies
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 |
|---|---|---|
| FenobamAlso: [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate]Fenobam 150 mg will be administered and subjects will be monitored for up to 8 hours. During the study day questionnaires will be administered, blood will be drawn a testing site will be marked and pain testing and heat/capsaicin sensitization will be measured. | Drug | Treatment regimn 1 |
| PlaceboAlso: Lactose monohydrateA placebo will be administered and subjects will be monitored for up to 8 hours. During the study day questionnaires will be administered, blood will be drawn a testing site will be marked and pain testing and heat/capsaicin sensitization will be measured. | Drug | Treatment Regimen 2 |
Primary outcome
Suppression of the development of cutaneous hyperalgesia and allodynia around the area treated with heat/capsaicin.
Time frame: During approximately 7 hours of consecutive assessments
size of the area of hyperalgesia and allodynia around the area sensitized by heat/capsaicin as quantified by cutaneous stimulation with foam brush strokes and a von Frey filament requiring 26 g of bending force.
5 secondary outcomes
Evaluation of nociception after drug administration as evaluated by prolonged (1 min) thermal stimulation on normal (untreated) skin.
Time frame: During approximately 7 hours of consecutive assessments
Assessment of Heat Pain Detection Thresholds (HPDT) in normal and sensitized skin pre and post treatment with fenobam.
Time frame: During approximately 7 hours of consecutive assessments
Absence of significant side effects
Time frame: 7 days
Assessment of significant change in mood/affect
Time frame: During approximately 6 hours of consecutive assessments
Assessment of significant change in cognitive function
Time frame: During approximately 6 hours of consecutive assessments
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 29 Apr 2016.
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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.
Laura F Cavallone, M.D. principal investigator
Washington University School of Medicine
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 Fenobam in people with Hyperalgesia and Allodynia, run by Laura Cavallone 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 5 inclusion and 9 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 29 Apr 2016. 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. Some participants in this study may receive a placebo. 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?
Suppression of the development of cutaneous hyperalgesia and allodynia around the area treated with heat/capsaicin. (time frame: During approximately 7 hours of consecutive assessments). 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 29 Apr 2016.