Intravenous Infusion of Esketamine in Combination With Pregabalin and Duloxetine for Postherpetic Neuralgia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To assess the 1-week effects and safety of esketamine in combination with pregabalin and duloxetine to relieve pain in patients with postherpetic Neuralgia(PHN).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Ages more than 18 years;

• Pain present for more than 3 months after healing of a herpes zoster skin rash;

• Has an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0= no pain, 10= worst possible pain);

• Failed to respond to or tolerate the effective dose of pregabalin monotherapy.

Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
Contact Information
Primary
Fang Luo, M.D.
13611326978@163.com
+86 13611326978
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 150
Treatments
Experimental: the esketamine group
In the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine. A total of 0.5 mg/kg of esketamine will be diluted in 50 mL of normal saline. The infusion will commence with an intravenous injection of 10 mg of esketamine over 1 minute, followed by a maintenance dose of 8 mg/h. The infusion rate will be adjusted based on the patients' tolerance levels.
Placebo_comparator: the control group
In the control group, patients will receive pregabaline combined with duloxetine. Pregabaline will be administered at a dose of 50-75 mg, twice daily during the first 3 days of treatment, and increase to 300mg daily after 3-7days, then by an additional 150mg daily every 3-7 days as tolerated, up to a maximum daily dose of 600mg. Meanwhile, duloxetine will be prescribed at an initial daily dose of 30mg, and then gradually increased to 60 mg daily after one week if patients tolerate it well.
Related Therapeutic Areas
Sponsors
Collaborators: Beijing Xiaotangshan Hospital, Hengshui People's Hospital, The First Hospital of Fangshan District,Beijing, Beijing Ditan Hospital
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov