Health TrialsbyHealthPanel

Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia

ConditionPostherpetic Neuralgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Obstructive sleep apnoea syndrome;

Those who receive interventional treatments;

A history of systemic immune diseases, organ transplantation, or cancers;

A history of severe cardiopulmonary, hepatic or renal dysfunction;

Trial design

Design model

Parallel

Treatments tested in this trial

  • esketamine group

    Drug

    In the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine.

  • control group

    Drug

    receiving the combination of pregabalin and duloxetine

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: the esketamine groupExperimental treatment 1 intervention
Group B: the control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

the mean of daily pain scores

the mean of daily pain scores collected during week 1 of treatment measured using the Numerical Pain Rating Scale (NRS,, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain).

Time frame
during 1 week

Secondary outcomes

1

Averaged weekly NRS score

Averaged weekly NRS score of each participant.Generally, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain

Time frame
1 week, 2 weeks, 3 weeks, and 1 month after treatment
2

percentages of patients having >50% reductions in 24-hour average pain severity during the first week

percentages of patients having \>50% reductions

Time frame
during the first week
3

the 12-item Short-Form Health Survey (SF-12) score

Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status).

Time frame
1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
4

the Pittsburgh Sleep Quality Index (PSQI) score

Sleep quality measured by PSQI score (range 0-21, with higher scores indicating poorer sleep quality).

Time frame
1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Beijing Xiaotangshan Hospital

Collaborator

The First Hospital of Fangshan District,Beijing

Collaborator

Beijing Ditan Hospital

Collaborator

Hengshui People's Hospital

Collaborator

Source ClinicalTrials.gov
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