Acute-onset Herpes Zoster PainPhase 1NCT02679339
Study to Evaluate the Safety and Pharmacokinetics of Topically Applied 40% Lidocaine Gel Compared With Placebo in Subjects With Acute Herpes Zoster (Shingles) Pain
A Phase 1 study testing CNTX-2022 (lidocaine gel, 40%) in people with Acute-onset Herpes Zoster Pain, run by Centrexion Therapeutics at 1 site in Australia.
Trial summary
Study 2022-HZ-011 will utilize a randomized withdrawal (RW), double-blind, placebo controlled design in which the PK and safety of CNTX 2022 (40% anhydrous lidocaine gel) will be evaluated in subjects with acute-onset herpes zoster pain. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute-onset Herpes Zoster Pain
- What is being tested?
- CNTX-2022 (lidocaine gel, 40%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2015to Aug 2015
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a male or female ≥ 18 years of age and ≤ 85 years of age.
- Subject has brush-evoked allodynic pain intensity score ≥ 4 using the NPRS as determined by pain assessment during the physical examination at screening.
- Onset must have occurred ≤ 20 days prior to randomization
- Subject has an average daily pain intensity score of ≥ 4 using the NPRS as determined by pain assessment during the physical examination at screening.
- Subject must have a diagnosis of herpes zoster (shingles).
- Subject has rash limited to trunk and limbs, with a total surface area of up to 300 cm2.
Who cannot join
- Subject has an active herpes zoster lesion on the face, head, neck, genital or rectal areas.
- Subject has rash limited to trunk and limbs, with a total surface area greater than 300 cm2.
- Subject has a known history of allergic reaction, hypersensitivity, or clinically significant intolerance to lidocaine, ingredients of the study drug, or local anesthetics of the amide type.
- Subject has target skin area (allodynic area and surrounding skin) that is not intact, is inflamed, or in the opinion of the Principal Investigator, consistent with rash due to acute herpes zoster.
- Subject has any other form of pain that was not discernible from herpes zoster (shingles) allodynia.
- Subject is taking Class I antiarrhythmic drugs (e.g., tocainide, mexiletine), or medications that could interact with the study drug or interfere with its evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Pilot Multiple Dose, Randomized-Withdrawal, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacokinetics of Topically Applied 40% Lidocaine Gel Compared With Placebo in Subjects With Acute Herpes Zoster Pain
Study 2022-HZ-011 will utilize a randomized withdrawal (RW), double-blind, placebo controlled design in which the PK and safety of CNTX 2022 (40% anhydrous lidocaine gel) will be evaluated in subjects with acute-onset herpes zoster pain.
- Conditions
- Acute-onset Herpes Zoster Pain
- Being tested
- CNTX-2022 (lidocaine gel, 40%), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTX-2022 (lidocaine gel, 40%)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CNTX-2022 (lidocaine gel, 40%) | Experimental | Application of 1mL CTNX-2022 (40% Anhydrous Lidocaine Gel) topically applied to 300cm squared outlined area once daily (in the morning) for 8 days at the study site. Receives: Drug: CNTX-2022 (lidocaine gel, 40%) |
| Placebo | Placebo comparator | Application of 1mL placebo topically applied to 300cm squared outlined area once daily (in the morning) for 8 days at the study site. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of topically applied 40% lidocaine gel measuring incidence, intensity, relationship, and seriousness of treatment-emergent AEs
Measured: 28 days
To evaluate the pharmacokinetics of topically applied 40% lidocaine gel measuring Tmax
Measured: 28 days
Secondary outcomes (1)
To assess the effect of 40% lidocaine gel on 0-10 numeric pain rating scale (NPRS) scores related to acute herpes zoster
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Limited patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-onset Herpes Zoster 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centrexion Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Araco, MD, Principal investigator, Nucleus Network Melbourne, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679339
- Sponsor's protocol ID
- 2022-HZ-011
- Status last verified
- Feb 2016
- First submitted
- 9 Feb 2015
- Last updated
- 10 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Pilot Multiple Dose, Randomized-Withdrawal, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacokinetics of Topically Applied 40% Lidocaine Gel Compared With Placebo in Subjects With Acute Herpes Zoster Pain
- ClinicalTrials.gov ID
- NCT02679339
- Acronym / sponsor ID
- 2022-HZ-011
- Conditions
- Acute-onset Herpes Zoster Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited patient enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Feb 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.
Study 2022-HZ-011 will utilize a randomized withdrawal (RW), double-blind, placebo controlled design in which the PK and safety of CNTX 2022 (40% anhydrous lidocaine gel) will be evaluated in subjects with acute-onset herpes zoster pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CNTX-2022 (lidocaine gel, 40%) | Experimental | Drug: CNTX-2022 (lidocaine gel, 40%)Application of 1mL CTNX-2022 (40% Anhydrous Lidocaine Gel) topically applied to 300cm squared outlined area once daily (in the morning) for 8 days at the study site. |
| Placebo | Placebo comparator | Drug: PlaceboApplication of 1mL placebo topically applied to 300cm squared outlined area once daily (in the morning) for 8 days at the study site. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is a male or female ≥ 18 years of age and ≤ 85 years of age.
- Subject has brush-evoked allodynic pain intensity score ≥ 4 using the NPRS as determined by pain assessment during the physical examination at screening.
- Subject has an average daily pain intensity score of ≥ 4 using the NPRS as determined by pain assessment during the physical examination at screening.
- Subject must have a diagnosis of herpes zoster (shingles).
- Subject has rash limited to trunk and limbs, with a total surface area of up to 300 cm2.
Key exclusion criteria (6 listed)
- Subject has an active herpes zoster lesion on the face, head, neck, genital or rectal areas.
- Subject has rash limited to trunk and limbs, with a total surface area greater than 300 cm2.
- Subject has a known history of allergic reaction, hypersensitivity, or clinically significant intolerance to lidocaine, ingredients of the study drug, or local anesthetics of the amide type.
- Subject has target skin area (allodynic area and surrounding skin) that is not intact, is inflamed, or in the opinion of the Principal Investigator, consistent with rash due to acute herpes zoster.
- Subject has any other form of pain that was not discernible from herpes zoster (shingles) allodynia.
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 |
|---|---|---|
| CNTX-2022 (lidocaine gel, 40%) | Drug | CNTX-2022 (lidocaine gel, 40%) |
| Placebo | Drug | Placebo |
Primary outcome
To evaluate the safety of topically applied 40% lidocaine gel measuring incidence, intensity, relationship, and seriousness of treatment-emergent AEs
Time frame: 28 days
To evaluate the pharmacokinetics of topically applied 40% lidocaine gel measuring Tmax
Time frame: 28 days
1 secondary outcome
To assess the effect of 40% lidocaine gel on 0-10 numeric pain rating scale (NPRS) scores related to acute herpes zoster
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Limited patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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.
Michael Araco, MD principal investigator
Nucleus Network Melbourne, Australia
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 CNTX-2022 (lidocaine gel, 40%) in people with Acute-onset Herpes Zoster Pain, run by Centrexion Therapeutics at 1 site in Australia.
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 6 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: stopped early, as of the sponsor's last update on 10 Feb 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 Australia. 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 was stopped early (reason given: Limited patient enrollment). Results are not available in the source record.
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 evaluate the safety of topically applied 40% lidocaine gel measuring incidence, intensity, relationship, and seriousness of treatment-emergent AEs (time frame: 28 days). The study lists 2 primary outcomes in all. 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 10 Feb 2016.