drugset / Trial / NCT04313335
Duloxetine for PHN
Completed
750 enrolled
Beijing Tiantan Hospital
Baoding First Central Hospital · collabBeijing Tsinghua Chang Gung Hospital · collabCangzhou Central Hospital · collabChina-Japan Friendship Hospital · collabFirst Hospital of China Medical University · collabFujian Provincial Hospital · collabLinfen Fourth People's Hospital · collabPeking University International Hospital · collabQingdao Municipal Hospital · collabSecond Affiliated Hospital of Zhengzhou University · collabShandong Provincial Hospital · collabTaiyuan Central Hospital of Shanxi Medical University · collabThe People's Hospital of Fujian Province · collabThe Second People's Hospital of Huai'an · collabTianjin First Central Hospital · collabTianjin Huanhu Hospital · collabTianjin Medical University Second Hospital · collab
RandomizedParallel-groupSingle-blindPrevention
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.
Timeline
- Start
- 2021-03-01
- Primary completion
- 2023-05-16
- Completion
- 2023-05-16
Outcome
Missed primary endpoint
paper There was no significant difference in the incidence of PHN in the duloxetine group compared with the control group in the mITT analysis PMID 38015658 ↗
paper 86 [22.9%] of 375 vs 108 [28.8%] of 375; P = .067 PMID 38015658 ↗
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duloxetine | Small molecule | 60 mg | Oral |