Postherpetic NeuralgiaNCT04313335
Duloxetine for PHN
A study testing Duloxetine in people with Postherpetic Neuralgia, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
In this study, the investigators aim to investigate the preventive efficacy of prophylactic oral duloxetine during acute herpes zoster on postherpetic neuralgia and its safety. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 16 May 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages more than 50 years;
- diagnosed with uncomplicated acute herpes zoster;
- presents with vesicles within 72 hours;
- has an average pain score of at least 40/100 mm on a visual analog scale (VAS, 0 = no pain, 100 = worst possible pain, at opposite ends of a 100-mm line).
Who cannot join
- refuses to participate or to provide written informed consent;
- Zung Self-Rating Depression Scale raw score of more than 50 points;
- herpes zoster that involves with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system;
- has hemorrhagic or necrotizing lesions, satellite lesions, abnormal vesicles or acute retinal necrosis;
- has been on immunosuppressive therapy or mono- or multi-pharmacotherapy that involves any tricyclic antidepressant, valacyclovir, duloxetine or cytotoxic medications before acute HZ onset;
- has been diagnosed with hepatic, renal or immune dysfunction;
Show all 10Show fewer
- during pregnancy or breastfeeding at the time;
- hypersensitivity to the study drugs;
- has contraindications to valacyclovir or duloxetine;
- HZ vaccinated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Duloxetine Administration During Acute Herpes Zoster Prevents Postherpetic Neuralgia
In this study, the investigators aim to investigate the preventive efficacy of prophylactic oral duloxetine during acute herpes zoster on postherpetic neuralgia and its safety.
Read the detailed description
Postherpetic neuralgia is a common complication of herpes zoster. Several interventions have been investigated for the treatment of postherpetic neuralgia, however, there is a lack of preventive intervention on postherpetic neuralgia. A recent retrospective study revealed that the administration of gabapentin during the acute herpes zoster period significantly decreased the incidence of postherpetic neuralgia. In the present study, the investigators aim to conduct a prospective, randomized, open-label, endpoint blinded study to investigate the preventive efficacy of prophylactic use of duloxetine on postherpetic neuralgia.
- Conditions
- Postherpetic Neuralgia
- Being tested
- Duloxetine
- Keywords
- Postherpetic Neuralgia, Duloxetine
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Oral Duloxetine (up to 60 mg per day) will be given, titrated, tapered in accordance with the pain intensity during the acute herpes zoster period.
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Apart from the standard treatment, participants in the Duloxetine Arm will be administered with oral duloxetine (up to 60 mg per day) in the acute herpes zoster period. Receives: Drug: Duloxetine |
| Control | No intervention | Participants will be given the standard treatment during the acute herpes zoster period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventive efficacy of Postherpetic neuralgia
The proportion of participants in the Interventional Arm who gain a 0 score in a 100 mm visual analgue scale (0 mm = no pain, 100 mm = the most imaginable pain)
Measured: 12 weeks after the reactivation of acute herpes zoster
Secondary outcomes (4)
Averaged weekly VAS score
Averaged weekly VAS score of each participant
Measured: up to 12 weeks
Averaged weekly analgesic consumption
Averaged weekly consumption per analgesic of each participant
Measured: up to 12 weeks
Patients' overall quality of life
12-item Short-Form Health Survey (SF-12)
Measured: At the end of Weeks 4, 8, and 12
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) self-rated questionnaire
Measured: At the end of Weeks 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Mar 2021
- Primary completion16 May 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postherpetic NeuralgiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Tianjin Medical University Second Hospital, Taiyuan Central Hospital of Shanxi Medical University, Linfen No.4 People's Hospital, Shandong Provincial Hospital, Qingdao Municipal Hospital (Group), The Second People's Hospital of Huai'an, First Hospital of China Medical University, Second Affiliated Hospital of Zhengzhou University, Fujian Provincial Hospital, Cangzhou Central Hospital, The People's Hospital of Fujian Province, Beijing Tsinghua Chang Gung Hospital, Peking University International Hospital, Tianjin First Central Hospital, Tianjin Huanhu Hospital, Baoding First Central Hospital
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313335
- Sponsor's protocol ID
- KY 2020-009-02
- Status last verified
- Jan 2024
- First submitted
- 7 Mar 2020
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Drolet M, Brisson M, Schmader K, Levin M, Johnson R, Oxman M, Patrick D, Camden S, Mansi JA. Predictors of postherpetic neuralgia among patients with herpes zoster: a prospective study. J Pain. 2010 Nov;11(11):1211-21. doi: 10.1016/j.jpain.2010.02.020.
PubMed 20434957Johnson RW, Rice AS. Clinical practice. Postherpetic neuralgia. N Engl J Med. 2014 Oct 16;371(16):1526-33. doi: 10.1056/NEJMcp1403062. No abstract available.
PubMed 25317872Schutzer-Weissmann J, Farquhar-Smith P. Post-herpetic neuralgia - a review of current management and future directions. Expert Opin Pharmacother. 2017 Nov;18(16):1739-1750. doi: 10.1080/14656566.2017.1392508. Epub 2017 Oct 26.
PubMed 29025327Bulilete O, Leiva A, Rullan M, Roca A, Llobera J; PHN Group. Efficacy of gabapentin for the prevention of postherpetic neuralgia in patients with acute herpes zoster: A double blind, randomized controlled trial. PLoS One. 2019 Jun 5;14(6):e0217335. doi: 10.1371/journal.pone.0217335. eCollection 2019.
PubMed 31166976Ghanavatian S, Wie CS, Low RS, Zhang N, Montoya JM, Dhaliwal GS, Swanson DL. Premedication With Gabapentin Significantly Reduces the Risk of Postherpetic Neuralgia in Patients With Neuropathy. Mayo Clin Proc. 2019 Mar;94(3):484-489. doi: 10.1016/j.mayocp.2018.11.004. Epub 2019 Feb 2.
PubMed 30718068Zhao C, Zhang T, Zhu Q, Chen Z, Ren H, Shrestha N, Meng L, Shen Y, Luo F. PROCESS Trial: Effect of Duloxetine Premedication for Postherpetic Neuralgia Within 72 Hours of Herpes Zoster Reactivation-A Randomized Controlled Trial. Clin Infect Dis. 2024 Apr 10;78(4):880-888. doi: 10.1093/cid/ciad714.
PubMed 38015658Chen Z, Shrestha N, Zhao C, Fan B, Luo F. Effect of duloxetine premedication for postherpetic neuralgia within 72 h of herpes zoster reactivation [PROCESS]: a study protocol for a randomized controlled trial. Trials. 2020 Dec 9;21(1):1012. doi: 10.1186/s13063-020-04919-6.
PubMed 33298154
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Duloxetine Administration During Acute Herpes Zoster Prevents Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT04313335
- Acronym / sponsor ID
- KY 2020-009-02
- Conditions
- Postherpetic Neuralgia
- Keywords
- Postherpetic Neuralgia, Duloxetine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Tianjin Medical University Second Hospital, Taiyuan Central Hospital of Shanxi Medical University, Linfen No.4 People's Hospital, Shandong Provincial Hospital, Qingdao Municipal Hospital (Group), The Second People's Hospital of Huai'an, First Hospital of China Medical University, Second Affiliated Hospital of Zhengzhou University, Fujian Provincial Hospital, Cangzhou Central Hospital, The People's Hospital of Fujian Province, Beijing Tsinghua Chang Gung Hospital, Peking University International Hospital, Tianjin First Central Hospital, Tianjin Huanhu Hospital, Baoding First Central Hospital
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 18 Mar 2020 (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.
In this study, the investigators aim to investigate the preventive efficacy of prophylactic oral duloxetine during acute herpes zoster on postherpetic neuralgia and its safety.
Detailed description
Postherpetic neuralgia is a common complication of herpes zoster. Several interventions have been investigated for the treatment of postherpetic neuralgia, however, there is a lack of preventive intervention on postherpetic neuralgia. A recent retrospective study revealed that the administration of gabapentin during the acute herpes zoster period significantly decreased the incidence of postherpetic neuralgia. In the present study, the investigators aim to conduct a prospective, randomized, open-label, endpoint blinded study to investigate the preventive efficacy of prophylactic use of duloxetine on postherpetic neuralgia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: DuloxetineApart from the standard treatment, participants in the Duloxetine Arm will be administered with oral duloxetine (up to 60 mg per day) in the acute herpes zoster period. |
| Control | No intervention | –Participants will be given the standard treatment during the acute herpes zoster period. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ages more than 50 years;
- diagnosed with uncomplicated acute herpes zoster;
- presents with vesicles within 72 hours;
- has an average pain score of at least 40/100 mm on a visual analog scale (VAS, 0 = no pain, 100 = worst possible pain, at opposite ends of a 100-mm line).
Key exclusion criteria (10 listed)
- refuses to participate or to provide written informed consent;
- Zung Self-Rating Depression Scale raw score of more than 50 points;
- herpes zoster that involves with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system;
- has hemorrhagic or necrotizing lesions, satellite lesions, abnormal vesicles or acute retinal necrosis;
- has been on immunosuppressive therapy or mono- or multi-pharmacotherapy that involves any tricyclic antidepressant, valacyclovir, duloxetine or cytotoxic medications before acute HZ onset;
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 |
|---|---|---|
| DuloxetineOral Duloxetine (up to 60 mg per day) will be given, titrated, tapered in accordance with the pain intensity during the acute herpes zoster period. | Drug | Duloxetine |
Primary outcome
Preventive efficacy of Postherpetic neuralgia
Time frame: 12 weeks after the reactivation of acute herpes zoster
The proportion of participants in the Interventional Arm who gain a 0 score in a 100 mm visual analgue scale (0 mm = no pain, 100 mm = the most imaginable pain)
4 secondary outcomes
Averaged weekly VAS score
Time frame: up to 12 weeks
Averaged weekly analgesic consumption
Time frame: up to 12 weeks
Patients' overall quality of life
Time frame: At the end of Weeks 4, 8, and 12
Sleep quality
Time frame: At the end of Weeks 4, 8, and 12
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 9 Jan 2024.
- Background: PubMed 20434957Drolet M, Brisson M, Schmader K, Levin M, Johnson R, Oxman M, Patrick D, Camden S, Mansi JA. Predictors of postherpetic neuralgia among patients with herpes zoster: a prospective study. J Pain. 2010 Nov;11(11):1211-21. doi: 10.1016/j.jpain.2010.02.020.
- Background: PubMed 25317872Johnson RW, Rice AS. Clinical practice. Postherpetic neuralgia. N Engl J Med. 2014 Oct 16;371(16):1526-33. doi: 10.1056/NEJMcp1403062. No abstract available.
- Background: PubMed 29025327Schutzer-Weissmann J, Farquhar-Smith P. Post-herpetic neuralgia - a review of current management and future directions. Expert Opin Pharmacother. 2017 Nov;18(16):1739-1750. doi: 10.1080/14656566.2017.1392508. Epub 2017 Oct 26.
- Background: PubMed 31166976Bulilete O, Leiva A, Rullan M, Roca A, Llobera J; PHN Group. Efficacy of gabapentin for the prevention of postherpetic neuralgia in patients with acute herpes zoster: A double blind, randomized controlled trial. PLoS One. 2019 Jun 5;14(6):e0217335. doi: 10.1371/journal.pone.0217335. eCollection 2019.
- Background: PubMed 30718068Ghanavatian S, Wie CS, Low RS, Zhang N, Montoya JM, Dhaliwal GS, Swanson DL. Premedication With Gabapentin Significantly Reduces the Risk of Postherpetic Neuralgia in Patients With Neuropathy. Mayo Clin Proc. 2019 Mar;94(3):484-489. doi: 10.1016/j.mayocp.2018.11.004. Epub 2019 Feb 2.
- Derived from this study: PubMed 38015658Zhao C, Zhang T, Zhu Q, Chen Z, Ren H, Shrestha N, Meng L, Shen Y, Luo F. PROCESS Trial: Effect of Duloxetine Premedication for Postherpetic Neuralgia Within 72 Hours of Herpes Zoster Reactivation-A Randomized Controlled Trial. Clin Infect Dis. 2024 Apr 10;78(4):880-888. doi: 10.1093/cid/ciad714.
- Derived from this study: PubMed 33298154Chen Z, Shrestha N, Zhao C, Fan B, Luo F. Effect of duloxetine premedication for postherpetic neuralgia within 72 h of herpes zoster reactivation [PROCESS]: a study protocol for a randomized controlled trial. Trials. 2020 Dec 9;21(1):1012. doi: 10.1186/s13063-020-04919-6.
- Individual participant dataSharing planned: Undecided
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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 study testing Duloxetine in people with Postherpetic Neuralgia, run by Beijing Tiantan Hospital 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 4 inclusion and 10 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 9 Jan 2024. 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.
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?
Preventive efficacy of Postherpetic neuralgia (time frame: 12 weeks after the reactivation of acute herpes zoster). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04313335, which also lists 7 linked publications.
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 9 Jan 2024.