PainPhase 1NCT02695745
Experimental Biomarker Study for Pain Thresholds
A Phase 1 study testing V116517 aqueous suspension, Celecoxib capsules and Capsaicin in people with Pain, run by Purdue Pharma LP at 1 site in Denmark.
Trial summary
The purpose of this study is to characterize the heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by UVB (ultraviolet B) irradiation and topical… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- V116517 aqueous suspension, Celecoxib capsules and Capsaicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Jan 2012
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent obtained.
- Males aged 18 to 45, inclusive.
- Body weight ranging from 50 to 100 kg and BMI ranging from 18 to 32 (kg/m2), inclusive.
- Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ECG.
Who cannot join
- Current or recent (within 5 years) history of drug or alcohol abuse.
- History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- Any history of frequent nausea or emesis regardless of etiology.
- Any history of allergic-type reactions to sulfonamides, or any experience of asthma, urticarial, or other allergic-type reactions after taking aspirin or other NSAIDS.
- Subjects who do not develop erythema at the maximum dose of the UVB source (MED determination for UVB model) will be excluded from the study.
- Other protocol-specific inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind, Positive- Controlled, Three-way Cross-over Human Experimental Biomarker Study of V116517 in Healthy Male Subjects
The purpose of this study is to characterize the heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by UVB (ultraviolet B) irradiation and topical capsaicin.
- Conditions
- Pain
- Being tested
- V116517 aqueous suspension, Celecoxib capsules, Placebo, Capsaicin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V116517 aqueous suspensionDrug
300 mg (approximately 100 mL) aqueous suspension taken orally x 1 dose
Celecoxib capsulesDrug
Also called Celebrex®, Celebra®
400 mg (2 capsules of 200 mg each) taken orally x 1 dose
PlaceboDrug
Placebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose
CapsaicinDrug
1% administered topically
| Study group | Role | What they receive |
|---|---|---|
| V116517 | Experimental | V116517 aqueous suspension; 300 mg Receives: Drug: V116517 aqueous suspension; Drug: Placebo; Drug: Capsaicin |
| Celecoxib | Active comparator | Celecoxib capsules; 400 mg (2 capsules of 200 mg each) Receives: Drug: Celecoxib capsules; Drug: Placebo; Drug: Capsaicin |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo; Drug: Capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application
Mean temperature in degrees Celsius (°C) based on the difference (post-dose and pre-dose) of the differences between the capsaicin at the control arm and the treated arm
Measured: 3.5 hours post-dose
Secondary outcomes (9)
Heat Pain Threshold (HPTr)
Mean temperature in degrees Celsius (°C)
Measured: 3.5 hours post-dose
Heat Pain tolerance threshold (HPTolTr)
Mean temperature in degrees Celsius (°C)
Measured: Pre-dose and 3.5 hours post-dose
Pressure Pain Threshold (PPTr)
Mean pressure kPA
Measured: 3.5 hours post-dose
Pressure Pain tolerance threshold (PPTolTr)
Mean pressure kPA
Measured: 3.5 hours post-dose
Peripheral nociceptor activation using Laser Doppler flowmetry
Peripheral nociceptor activation will be assessed by monitoring cutaneous blood flow using Laser Doppler imaging
Measured: 3.5 hours post-dose
Erythema at the treated area using Erythema index
Erythema at the treated area will be assessed using colorimetry
Measured: 3.5 hours post-dose
Stimulus-response function to graded von Frey hair stimulation
The mean pain intensity of the stimulations on a '0-10' visual analog scale (VAS), where '0' indicates ''no pain" and '10' indicates '' the most intense pain imaginable''
Measured: 3.5 hours post-dose
Secondary pin-prick hyperalgesic area
The area will be assessed using a 60 g weighted von Frey hair, and subjects are asked to report when the sensation changes to a "different sensation", "unpleasant" or "burning pain" sensation
Measured: 3.5 hours post-dose
Evaluation of change in body temperature
Oral temperature in degrees Celsius (˚C)
Measured: Pre-dose and up to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionJan 2012
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695745
- Sponsor's protocol ID
- VND1004
- Other IDs
- 2011-002399-18
- Status last verified
- Feb 2016
- First submitted
- 22 Feb 2016
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Positive- Controlled, Three-way Cross-over Human Experimental Biomarker Study of V116517 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02695745
- Acronym / sponsor ID
- VND1004
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 Mar 2016 (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 characterize the heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by UVB (ultraviolet B) irradiation and topical capsaicin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| V116517 | Experimental | Drug: V116517 aqueous suspension, Drug: Placebo, Drug: CapsaicinV116517 aqueous suspension; 300 mg |
| Celecoxib | Active comparator | Drug: Celecoxib capsules, Drug: Placebo, Drug: CapsaicinCelecoxib capsules; 400 mg (2 capsules of 200 mg each) |
| Placebo | Placebo comparator | Drug: Placebo, Drug: CapsaicinPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent obtained.
- Males aged 18 to 45, inclusive.
- Body weight ranging from 50 to 100 kg and BMI ranging from 18 to 32 (kg/m2), inclusive.
- Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ECG.
Key exclusion criteria (6 listed)
- Current or recent (within 5 years) history of drug or alcohol abuse.
- History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- Any history of frequent nausea or emesis regardless of etiology.
- Any history of allergic-type reactions to sulfonamides, or any experience of asthma, urticarial, or other allergic-type reactions after taking aspirin or other NSAIDS.
- Subjects who do not develop erythema at the maximum dose of the UVB source (MED determination for UVB model) will be excluded from the study.
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 |
|---|---|---|
| V116517 aqueous suspension300 mg (approximately 100 mL) aqueous suspension taken orally x 1 dose | Drug | V116517 |
| Celecoxib capsulesAlso: Celebrex®, Celebra®400 mg (2 capsules of 200 mg each) taken orally x 1 dose | Drug | Celecoxib |
| PlaceboPlacebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose | Drug | Celecoxib, Placebo, V116517 |
| Capsaicin1% administered topically | Drug | Celecoxib, Placebo, V116517 |
Primary outcome
Heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application
Time frame: 3.5 hours post-dose
Mean temperature in degrees Celsius (°C) based on the difference (post-dose and pre-dose) of the differences between the capsaicin at the control arm and the treated arm
9 secondary outcomes
Heat Pain Threshold (HPTr)
Time frame: 3.5 hours post-dose
Heat Pain tolerance threshold (HPTolTr)
Time frame: Pre-dose and 3.5 hours post-dose
Pressure Pain Threshold (PPTr)
Time frame: 3.5 hours post-dose
Pressure Pain tolerance threshold (PPTolTr)
Time frame: 3.5 hours post-dose
Peripheral nociceptor activation using Laser Doppler flowmetry
Time frame: 3.5 hours post-dose
Erythema at the treated area using Erythema index
Time frame: 3.5 hours post-dose
Stimulus-response function to graded von Frey hair stimulation
Time frame: 3.5 hours post-dose
Secondary pin-prick hyperalgesic area
Time frame: 3.5 hours post-dose
Evaluation of change in body temperature
Time frame: Pre-dose and up to 72 hours post-dose
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 1 Mar 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 V116517 aqueous suspension, Celecoxib capsules and Capsaicin in people with Pain, run by Purdue Pharma LP at 1 site in Denmark.
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 4 inclusion and 6 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 1 Mar 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 Denmark. 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?
Heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application (time frame: 3.5 hours post-dose). 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 1 Mar 2016.