Herpetic NeuralgiaPhase 3NCT03186443
Pregabalin Treatment and Prevention Post-herpetic Neuralgia
A Phase 3 study testing Pregabalin and Gabapentin in people with Herpetic Neuralgia, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Pregabalin is effective on herpetic neuralgia, but whether can prevention post-herpetic neuralgia still need to confirm. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Herpetic Neuralgia
- What is being tested?
- Pregabalin and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 1 Oct 2017
- Phase
- Phase 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain occurs within 90 days of rash onset
- Numerical rating scale (NRS) greater than 50 mm
Who cannot join
- Patient with nervous system disorders which impair completing the pain diaries
- Patient with history of illicit drug or alcohol abuse within the last 2 years
Trial locations and contacts
1 site in 1 country.
China1 site
National drug clinical trial fundation
Guangzhou, Guangdong, 510260
Chu-Yan Lin, M.D.
Li Wan, Ph.D.,M.D.
About this study
Official title: Prevention Effect of Pregabalin on Postherpetic Neuralgia: A Multicenter, Randomized, Double-blind, Controlled Trial
Pregabalin is effective on herpetic neuralgia, but whether can prevention post-herpetic neuralgia still need to confirm.
Read the detailed description
Pregabalin has been recommended as the first-line drug for post-herpetic neuralgia (PHN) therapy currently due to its efficacy and safety. However,there was no valuable report at present on the clinical efficacy of pregabalin for acute and subacute herpetic neuralgia (SHN), expect for a smaller study which included 29 outpatients who had acute zoster pain for a period of 7-1 4 days. And it is not clear whether early application of pregabalin can reduce the incidence of PHN.
Therefore, this study was rational designed to evaluate the efficacy and safety of pregabalin in the treatment of herpetic neuralgia，and follow-up to the 8 months, evaluation whether impacting the accidence of PHN.
It is the first time in the international that treating acute herpetic neuralgia (AHN) and SHN with pregabalin as a large sample size clinical trial. The results of this study will be great significance for guiding the clinical medication.
- Conditions
- Herpetic Neuralgia
- Being tested
- Pregabalin, Gabapentin
- Keywords
- herpetic neuralgia, post-herpetic neuralgia, pregabalin
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called pregabalin tablet
Pregabalin was taken 300mg,q 12h for 6 month.
GabapentinDrug
Also called gabapentin tablet
Gabapentin was taken 0.4, tid for 6 month.
| Study group | Role | What they receive |
|---|---|---|
| pregabalin | Active comparator | experiment group: pregabalin 300mg,q12h for 6 months Receives: Drug: Pregabalin |
| gabapentin | Experimental | compared to pregabalin effect on herpetic neuralgia Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes of numerical rating scale (NRS)
Pain intensity was rated on an 1 1-point numerical rating scale
Measured: from the date of start to 8 month
Secondary outcomes (1)
Brief Pain Inventory (BPI)
quality of life was rated on Brief Pain Inventory
Measured: baseline and 8th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Oct 2017 (estimated)
- Study completion1 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- control group is to oral gabapentin 0.4 tid； experiment group is to oral pregabalin 300mg q 12h
- Masking
- None (open label)
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Nanjing PLA General Hospital, Air Force Military Medical University, China
- Responsible party
- Sponsor
- Investigators
- Li Wan, Ph.D.,M.D., Study director, The Second Affiliated Hospital, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186443
- Sponsor's protocol ID
- TT-01
- Status last verified
- Jun 2017
- First submitted
- 7 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Effect of Pregabalin on Postherpetic Neuralgia: A Multicenter, Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT03186443
- Acronym / sponsor ID
- TT-01
- Conditions
- Herpetic Neuralgia
- Keywords
- herpetic neuralgia, post-herpetic neuralgia, pregabalin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Nanjing PLA General Hospital, Air Force Military Medical University, China
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Oct 2017 (estimated)
- Study completion
- 1 Oct 2017 (estimated)
- First posted
- 14 Jun 2017 (actual)
- 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.
Pregabalin is effective on herpetic neuralgia, but whether can prevention post-herpetic neuralgia still need to confirm.
Detailed description
Pregabalin has been recommended as the first-line drug for post-herpetic neuralgia (PHN) therapy currently due to its efficacy and safety. However,there was no valuable report at present on the clinical efficacy of pregabalin for acute and subacute herpetic neuralgia (SHN), expect for a smaller study which included 29 outpatients who had acute zoster pain for a period of 7-1 4 days. And it is not clear whether early application of pregabalin can reduce the incidence of PHN.
Therefore, this study was rational designed to evaluate the efficacy and safety of pregabalin in the treatment of herpetic neuralgia，and follow-up to the 8 months, evaluation whether impacting the accidence of PHN.
It is the first time in the international that treating acute herpetic neuralgia (AHN) and SHN with pregabalin as a large sample size clinical trial. The results of this study will be great significance for guiding the clinical medication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- control group is to oral gabapentin 0.4 tid； experiment group is to oral pregabalin 300mg q 12h
| Arm | Type | Receives |
|---|---|---|
| pregabalin | Active comparator | Drug: Pregabalinexperiment group: pregabalin 300mg,q12h for 6 months |
| gabapentin | Experimental | Drug: Gabapentincompared to pregabalin effect on herpetic neuralgia |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pain occurs within 90 days of rash onset
- Numerical rating scale (NRS) greater than 50 mm
Key exclusion criteria (2 listed)
- Patient with nervous system disorders which impair completing the pain diaries
- Patient with history of illicit drug or alcohol abuse within the last 2 years
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 |
|---|---|---|
| PregabalinAlso: pregabalin tabletPregabalin was taken 300mg,q 12h for 6 month. | Drug | pregabalin |
| GabapentinAlso: gabapentin tabletGabapentin was taken 0.4, tid for 6 month. | Drug | gabapentin |
Primary outcome
the changes of numerical rating scale (NRS)
Time frame: from the date of start to 8 month
Pain intensity was rated on an 1 1-point numerical rating scale
1 secondary outcome
Brief Pain Inventory (BPI)
Time frame: baseline and 8th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- 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.
Li Wan, Ph.D.,M.D. study director
The Second Affiliated Hospital, Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin and Gabapentin in people with Herpetic Neuralgia, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Jun 2017. 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 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. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Wan, Ph.D.,M.D. (18122256632, wanli5000cn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changes of numerical rating scale (NRS) (time frame: from the date of start to 8 month). 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 Jun 2017.