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| Name | Class |
|---|---|
| China-Japan Friendship Hospital | OTHER |
| Tianjin Medical University Second Hospital | OTHER |
| Taiyuan Central Hospital of Shanxi Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Participants will be given the standard treatment during the acute herpes zoster period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 weeks after the reactivation of acute herpes zoster |
| Measure | Description | Time Frame |
|---|---|---|
| Averaged weekly VAS score | Averaged weekly VAS score of each participant | up to 12 weeks |
| Averaged weekly analgesic consumption | Averaged weekly consumption per analgesic of each participant |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20434957 | Background | 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. | |
| 25317872 | Background | Johnson 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. |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Linfen Fourth People's Hospital |
| UNKNOWN |
| Shandong Provincial Hospital | OTHER_GOV |
| Qingdao Municipal Hospital (Group) | UNKNOWN |
| The Second People's Hospital of Huai'an | OTHER |
| First Hospital of China Medical University | OTHER |
| Second Affiliated Hospital of Zhengzhou University | OTHER |
| Fujian Provincial Hospital | OTHER |
| Cangzhou Central Hospital | OTHER |
| The People's Hospital of Fujian Province | UNKNOWN |
| Beijing Tsinghua Chang Gung Hospital | OTHER |
| Peking University International Hospital | OTHER |
| Tianjin First Central Hospital | OTHER |
| Tianjin Huanhu Hospital | OTHER |
| Baoding First Central Hospital | OTHER |
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The outcome of the study will be assessed by a third-party organization who will be blinded to the study allocation.
| up to 12 weeks |
| Patients' overall quality of life | 12-item Short-Form Health Survey (SF-12) | At the end of Weeks 4, 8, and 12 |
| Sleep quality | Pittsburgh Sleep Quality Index (PSQI) self-rated questionnaire | At the end of Weeks 4, 8, and 12 |
| 29025327 | Background | Schutzer-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. |
| 31166976 | Background | Bulilete 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. |
| 30718068 | Background | Ghanavatian 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. |
| 38015658 | Derived | Zhao 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. |
| 33298154 | Derived | Chen 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. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |