Peripheral Neuropathic PainPhase 1NCT01240148
Determine the Effect of AZD3161,Injected Intradermally, on Quantitative Sensory Testing Variables in Normal and Ultraviolet-C (UVC) Exposed Skin in Healthy Volunteers
A Phase 1 study testing AZD3161 and Lidocaine in people with Peripheral Neuropathic Pain and Nociceptive Pain, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the effect of AZD3161 on mechanical pain sensitivity and axon reflex flare in normal and ultraviolet C irradiated skin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Neuropathic Pain, Nociceptive Pain
- What is being tested?
- AZD3161 and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2010to Mar 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Caucasian male and female volunteers aged 18 to 55 years inclusive with suitable veins for venepuncture
- The subject belongs to skin type II or III according to Fitzpatrick skin type scale
- Females must have a negative pregnancy test at screening and at admission, must not be lactating and must be of non-child-bearing potential
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh between 50 kg and 100 kg inclusive
- Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with investigational product.
Who cannot join
- Presence of skin disorders, tattoos or other skin conditions that may interfere with the QST measurements, as judged by the Investigator
- Recent exposure to significant amount of UV light, as judged by the Investigator.
- Use of any prescribed or non-prescribed analgesics (including paracetamol/acetaminophen or drugs affecting blood flow (including nasal anticongestants), prior to the first administration of investigational product that may interfere with the study objectives.
- History of severe allergy/hypersensitivity, or ongoing allergy/hypersensitivity as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD3161.
- Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Single-Centre Study to Determine the Effect of Intradermal AZD3161 on Quantitative Sensory Testing Variables in Normal and UVC Exposed Skin in Healthy Volunteers
The purpose of this study is to investigate the effect of AZD3161 on mechanical pain sensitivity and axon reflex flare in normal and ultraviolet C irradiated skin.
- Conditions
- Peripheral Neuropathic Pain, Nociceptive Pain
- Being tested
- AZD3161, Lidocaine, AZD3161 Placebo
- Keywords
- Allodynia, hyperalgesia, paresthesia
- Medical subject headings
- Nociceptive Pain, Hyperalgesia, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3161Drug
Single dose, intradermal injection
LidocaineDrug
Single dose, intradermal injection
AZD3161 PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 150 μL intradermal injection of 1 μmol/L AZD3161 Receives: Drug: AZD3161 |
| 2 | Experimental | 150 μL intradermal injection of 6 μmol/L AZD3161 Receives: Drug: AZD3161 |
| 3 | Experimental | 150 μL intradermal injection of 30 μmol/L AZD3161 Receives: Drug: AZD3161 |
| 4 | Active comparator | 150 μL intradermal injection of 10 mg/mL Lidocaine Receives: Drug: Lidocaine |
| 5 | Placebo comparator | 150 μL intradermal injection of AZD3161 placebo Receives: Drug: AZD3161 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of mechanical pain testing using Quantitative Sensory Testing
Measured: Day 1
Secondary outcomes (4)
Number of participants with Adverse Events
Measured: Range of 14 days
Vital signs
(blood pressure, heart rate, pulse)
Measured: Day 1
Clinical chemistry (urinalysis, hematology)
Measured: At follow up (a range of 8-15 days after Day 1)
The effect of AZD3161 on axon reflex flare in normal and UVC irradiated skin using a Laser doppler scan
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Darren Wilbraham, MD, MBBS DCPSA, Principal investigator, Quintiles Drug Research Unit at Guy's HospitalBo Fransson, Study chair, AstraZeneca R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240148
- Sponsor's protocol ID
- D3780C00005
- Status last verified
- Apr 2011
- First submitted
- 10 Nov 2010
- Last updated
- 12 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Single-Centre Study to Determine the Effect of Intradermal AZD3161 on Quantitative Sensory Testing Variables in Normal and UVC Exposed Skin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01240148
- Acronym / sponsor ID
- D3780C00005
- Conditions
- Peripheral Neuropathic Pain, Nociceptive Pain
- Keywords
- Allodynia, hyperalgesia, paresthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Nov 2010 (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 investigate the effect of AZD3161 on mechanical pain sensitivity and axon reflex flare in normal and ultraviolet C irradiated skin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD3161150 μL intradermal injection of 1 μmol/L AZD3161 |
| 2 | Experimental | Drug: AZD3161150 μL intradermal injection of 6 μmol/L AZD3161 |
| 3 | Experimental | Drug: AZD3161150 μL intradermal injection of 30 μmol/L AZD3161 |
| 4 | Active comparator | Drug: Lidocaine150 μL intradermal injection of 10 mg/mL Lidocaine |
| 5 | Placebo comparator | Drug: AZD3161 Placebo150 μL intradermal injection of AZD3161 placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Caucasian male and female volunteers aged 18 to 55 years inclusive with suitable veins for venepuncture
- The subject belongs to skin type II or III according to Fitzpatrick skin type scale
- Females must have a negative pregnancy test at screening and at admission, must not be lactating and must be of non-child-bearing potential
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh between 50 kg and 100 kg inclusive
- Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with investigational product.
Key exclusion criteria (5 listed)
- Presence of skin disorders, tattoos or other skin conditions that may interfere with the QST measurements, as judged by the Investigator
- Recent exposure to significant amount of UV light, as judged by the Investigator.
- Use of any prescribed or non-prescribed analgesics (including paracetamol/acetaminophen or drugs affecting blood flow (including nasal anticongestants), prior to the first administration of investigational product that may interfere with the study objectives.
- History of severe allergy/hypersensitivity, or ongoing allergy/hypersensitivity as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD3161.
- Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening
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 |
|---|---|---|
| AZD3161Single dose, intradermal injection | Drug | 1, 2, 3 |
| LidocaineSingle dose, intradermal injection | Drug | 4 |
| AZD3161 Placebo | Drug | 5 |
Primary outcome
Results of mechanical pain testing using Quantitative Sensory Testing
Time frame: Day 1
4 secondary outcomes
Number of participants with Adverse Events
Time frame: Range of 14 days
Vital signs
Time frame: Day 1
Clinical chemistry (urinalysis, hematology)
Time frame: At follow up (a range of 8-15 days after Day 1)
The effect of AZD3161 on axon reflex flare in normal and UVC irradiated skin using a Laser doppler scan
Time frame: Day 1
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 12 Apr 2011.
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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.
Darren Wilbraham, MD, MBBS DCPSA principal investigator
Quintiles Drug Research Unit at Guy's Hospital
Bo Fransson study chair
AstraZeneca R&D
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 AZD3161 and Lidocaine in people with Peripheral Neuropathic Pain and Nociceptive Pain, run by AstraZeneca at 1 site in United Kingdom.
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 5 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 12 Apr 2011. 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 Kingdom. 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?
Results of mechanical pain testing using Quantitative Sensory Testing (time frame: Day 1). 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 12 Apr 2011.