Duloxetine for PHN
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|ClinicalTrials.gov Identifier: NCT04313335|
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : March 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Postherpetic Neuralgia||Drug: Duloxetine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The outcome of the study will be assessed by a third-party organization who will be blinded to the study allocation.|
|Official Title:||Prophylactic Duloxetine Administration During Acute Herpes Zoster Prevents Postherpetic Neuralgia|
|Actual Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
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.
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.
- 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)
- Averaged weekly VAS score [ Time Frame: up to 12 weeks ]Averaged weekly VAS score of each participant
- Averaged weekly analgesic consumption [ Time Frame: up to 12 weeks ]Averaged weekly consumption per analgesic of each participant
- Patients' overall quality of life [ Time Frame: At the end of Weeks 4, 8, and 12 ]12-item Short-Form Health Survey (SF-12)
- Sleep quality [ Time Frame: At the end of Weeks 4, 8, and 12 ]Pittsburgh Sleep Quality Index (PSQI) self-rated questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04313335
|Contact: Fang Luo, M.D.||+86 firstname.lastname@example.org|
|Beijing Tiantan Hospital||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: Fang Luo, M.D. +86 13611326978 email@example.com|
|Principal Investigator: Fang Luo, M.D.|