Duloxetine for PHN
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Duloxetine 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. |
Drug: Duloxetine
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.
|
| No Intervention: Control Participants will be given the standard treatment during the acute herpes zoster period. |
Outcome Measures
Primary Outcome Measures
- Preventive efficacy of Postherpetic neuralgia [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)
Secondary Outcome Measures
- Averaged weekly VAS score [up to 12 weeks]
Averaged weekly VAS score of each participant
- Averaged weekly analgesic consumption [up to 12 weeks]
Averaged weekly consumption per analgesic of each participant
- Patients' overall quality of life [At the end of Weeks 4, 8, and 12]
12-item Short-Form Health Survey (SF-12)
- Sleep quality [At the end of Weeks 4, 8, and 12]
Pittsburgh Sleep Quality Index (PSQI) self-rated questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
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ages more than 50 years;
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diagnosed with uncomplicated acute herpes zoster;
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presents with vesicles within 72 hours;
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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).
Exclusion Criteria:
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refuses to participate or to provide written informed consent;
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Zung Self-Rating Depression Scale raw score of more than 50 points;
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herpes zoster that involves with head, neck, ocular, mucous membrane, cranial nerve, or central nervous system;
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has hemorrhagic or necrotizing lesions, satellite lesions, abnormal vesicles or acute retinal necrosis;
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has been on immunosuppressive therapy or mono- or multi-pharmacotherapy that involves any tricyclic antidepressant, valacyclovir, duloxetine or cytotoxic medications before acute HZ onset;
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has been diagnosed with hepatic, renal or immune dysfunction;
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during pregnancy or breastfeeding at the time;
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hypersensitivity to the study drugs;
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has contraindications to valacyclovir or duloxetine;
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HZ vaccinated.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Tiantan Hospital | Beijing | Beijing | China | 100050 |
Sponsors and Collaborators
- Beijing Tiantan Hospital
- China-Japan Friendship Hospital
- Tianjin Medical University Second Hospital
- Taiyuan Central Hospital of Shanxi Medical University
- Linfen Fourth 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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Bulilete O, Leiva A, Rullán 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.
- 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.
- 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.
- Johnson RW, Rice AS. Clinical practice. Postherpetic neuralgia. N Engl J Med. 2014 Oct 16;371(16):1526-33. doi: 10.1056/NEJMcp1403062. Review.
- 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. Review.
- KY 2020-009-02