Herpes Zoster PainPhase 2/3NCT02452112
Efficacy and Safety of 5% Lidocaine Patch With Placebo Patch in Subjects With Herpes Zoster Associated Pain
A Phase 2/3 study testing 5% Lidocaine patch in people with Herpes Zoster Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 21 sites in China.
Trial summary
This is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of 5% lidocaine patch, following placebo or active patch applications in placebo insensitive subjects. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Herpes Zoster Pain
- What is being tested?
- 5% Lidocaine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 21 sitesChina
- Study dates
- 2 Nov 2014to 30 Oct 2016
- Phase
- Phase 2/3
- 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
- Male or female subjects 18 to 85 years of age.
- Subjects must have herpes zoster associated pain present for ≥1 months after healing of the acute herpes zoster skin rash and not located on the face, scalp; the diagnosis will be based on physical examination and review of available medical records confirming an episode of herpes zoster.
- Herpes zoster associated pain must be of at least moderate severity, defined as the average pain level ≥40 mm on a 100 mm visual analog scale (VAS slide ruler)
Who cannot join
- Subjects with signs of cord or brainstem injury from herpes zoster.
- Presence of another pain problem of greater severity than their herpes zoster associated pain.
- Subjects who have undergone neurolytic nerve blocks or ablative neurosurgical procedures for control of herpes zoster associated pain
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites
Beijing University People's Hospital
Beijing, Beijing Municipality, 100044
Air force general hospital
Beijing
Beijing friendship hospital
Beijing
Beijing university first hospital
Beijing
Beijing university third hospital
Beijing
The first affiliated hospital of Jilin university
Changchun
Xiangya hospital central south university
Changsha
South West Hospital
Chengdu
First affiliated hospital of Chongqing medical university
Chongqing
The first affiliated hospital of Dalian university
Dalian
Guangzhou general hospital
Guangzhou
The first affiliated hospital of Zhejiang university
Hangzhou
Shandong dermatology hospital
Jinan
The second affiliated hospital of Kunming medical college
Kunming
China dermatology research center
Nanjing
Shanghai Huashan hospital
Shanghai
Shanghai Ruijin Hospital
Shanghai
Shengjing Hospital
Shenyang
The fourth affiliated hospital of Hebei medical university
Shijiazhuang
General hospital of Tianjin medical university
Tianjin
Xijing Hospital
Xi'an
About this study
Official title: An Open-Label, Single and Multiple-Dose, Two-Period, Consecutive Study in Healthy Chinese Subjects to Assess the Pharmacokinetic Profiles, Safety and Tolerability of Lidocaine Patch 5%.LIG13-CN-101 Study
This is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of 5% lidocaine patch, following placebo or active patch applications in placebo insensitive subjects.
- Conditions
- Herpes Zoster Pain
- Being tested
- 5% Lidocaine patch, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Lidocaine patchDrug
Also called Lignopad
5% Lidocaine patch to be placed on the site of pain
PlaceboDrug
Placebo patch to be placed on the site of pain
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Active arm with administration of active 5% Lidocaine patch Receives: Drug: 5% Lidocaine patch |
| Placebo | Placebo comparator | Placebo arm with administration of placebo patch Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of VAS score
Mean change in the mean pain VAS score
Measured: over 24 hour from baseline to the post-treatment over time during double-blind period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study start2 Nov 2014
- Primary completion30 Dec 2015
- Study completion30 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452112
- Sponsor's protocol ID
- LIG13-CN-301
- Status last verified
- Nov 2017
- First submitted
- 20 May 2015
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single and Multiple-Dose, Two-Period, Consecutive Study in Healthy Chinese Subjects to Assess the Pharmacokinetic Profiles, Safety and Tolerability of Lidocaine Patch 5%.LIG13-CN-101 Study
- ClinicalTrials.gov ID
- NCT02452112
- Acronym / sponsor ID
- LIG13-CN-301
- Conditions
- Herpes Zoster Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2014 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Oct 2016 (actual)
- First posted
- 22 May 2015 (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.
This is a randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of 5% lidocaine patch, following placebo or active patch applications in placebo insensitive subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: 5% Lidocaine patchActive arm with administration of active 5% Lidocaine patch |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo arm with administration of placebo patch |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects 18 to 85 years of age.
- Subjects must have herpes zoster associated pain present for ≥1 months after healing of the acute herpes zoster skin rash and not located on the face, scalp; the diagnosis will be based on physical examination and review of available medical records confirming an episode of herpes zoster.
- Herpes zoster associated pain must be of at least moderate severity, defined as the average pain level ≥40 mm on a 100 mm visual analog scale (VAS slide ruler)
Key exclusion criteria (3 listed)
- Subjects with signs of cord or brainstem injury from herpes zoster.
- Presence of another pain problem of greater severity than their herpes zoster associated pain.
- Subjects who have undergone neurolytic nerve blocks or ablative neurosurgical procedures for control of herpes zoster associated pain
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 |
|---|---|---|
| 5% Lidocaine patchAlso: Lignopad5% Lidocaine patch to be placed on the site of pain | Drug | Lidocaine |
| PlaceboPlacebo patch to be placed on the site of pain | Drug | Placebo |
Primary outcome
Change of VAS score
Time frame: over 24 hour from baseline to the post-treatment over time during double-blind period
Mean change in the mean pain VAS score
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 14 Nov 2017.
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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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 5% Lidocaine patch in people with Herpes Zoster Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 21 sites in China.
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 3 inclusion and 3 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 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change of VAS score (time frame: over 24 hour from baseline to the post-treatment over time during double-blind period). 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 14 Nov 2017.