Postherpetic NeuralgiaNCT06896994
Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia
A study testing esketamine group in people with Postherpetic Neuralgia, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- esketamine group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
- Currently using monoamine oxidase inhibitors (MAOIs);
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- Having untreated angle-closure glaucoma;
- Those suffering from increased intracranial pressure；
- Comorbid hyperthyroidism or phaeochromocytoma;
- Suspected or confirmed history of drug abuse;
- Having contraindications to esketamine, pregabaline or duloxetine;
- Communication difficulties;
- Women who are preparing for pregnancy, in the pregnancy or lactation period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Fang Luo, M.D., +86 13611326978, 13611326978@163.com
About this study
Official title: Intravenous Infusion of Esketamine in Combination With Pregabalin and Duloxetine for Postherpetic Neuralgia
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).
Read the detailed description
The investigators aim to investigate whether or not esketamine combined with pregabalin and duloxetine to relieve pain in patients with PHN, and seek a rapid, effective and safe treatment for refractory patients with PHN
- Conditions
- Postherpetic Neuralgia
- Being tested
- esketamine group, control group
- Keywords
- Postherpetic Neuralgia, esketamine
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esketamine groupDrug
Also called pregabalin+duloxetine+esketamine
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 groupDrug
Also called pregabalin+duloxetine
receiving the combination of pregabalin and duloxetine
| Study group | Role | What they receive |
|---|---|---|
| the esketamine group | Experimental | 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. Receives: Drug: esketamine group |
| the control group | Placebo comparator | 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. Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: during 1 week
Secondary outcomes (8)
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
Measured: 1 week, 2 weeks, 3 weeks, and 1 month after treatment
percentages of patients having >50% reductions in 24-hour average pain severity during the first week
percentages of patients having >50% reductions
Measured: during the first week
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).
Measured: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
the Pittsburgh Sleep Quality Index (PSQI) score
Sleep quality measured by PSQI score (range 0-21, with higher scores indicating poorer sleep quality).
Measured: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
the Patient Global Impression of Change scale (PGIC)
The proportion of patients with a response of "no change", "minimally improved", "much improved" or "very much improved" on PGIC.
Measured: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
The Hospital Anxiety and Depression Scale (HADS)
It consists of two sub-scales. Each sub-scale consists of 7 items and each item scored from 0 to 3. A higher score indicates more severe anxiety or depression. A score of 11 or above can indicate clinically significant anxiety or depression.
Measured: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
Averaged weekly analgesic consumption
Averaged weekly consumption per analgesic of each participant
Measured: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
Safety assessments
drug-related complications,such as dizziness, somnolence, gait disturbance, nausea, fatigue, diarrhea, dry mouth, mental symptom, etc
Measured: 0 day, 1 day, 3 days, 7 days, 2 weeks,3 weeks, and 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Apr 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Xiaotangshan Hospital, The First Hospital of Fangshan District,Beijing, Beijing Ditan Hospital, Hengshui People's Hospital
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
- Investigators
- Fang Luo, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896994
- Sponsor's protocol ID
- KY-2024-332-02-02
- Status last verified
- Apr 2025
- First submitted
- 19 Mar 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Infusion of Esketamine in Combination With Pregabalin and Duloxetine for Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT06896994
- Acronym / sponsor ID
- KY-2024-332-02-02
- Conditions
- Postherpetic Neuralgia
- Keywords
- Postherpetic Neuralgia, esketamine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Xiaotangshan Hospital, The First Hospital of Fangshan District,Beijing, Beijing Ditan Hospital, Hengshui People's Hospital
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The investigators aim to investigate whether or not esketamine combined with pregabalin and duloxetine to relieve pain in patients with PHN, and seek a rapid, effective and safe treatment for refractory patients with PHN
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the esketamine group | Experimental | Drug: esketamine groupIn 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. |
| the control group | Placebo comparator | Drug: control groupIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
- A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esketamine groupAlso: pregabalin+duloxetine+esketamineIn the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine. | Drug | the esketamine group |
| control groupAlso: pregabalin+duloxetinereceiving the combination of pregabalin and duloxetine | Drug | the control group |
Primary outcome
the mean of daily pain scores
Time frame: during 1 week
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).
8 secondary outcomes
Averaged weekly NRS score
Time frame: 1 week, 2 weeks, 3 weeks, and 1 month after treatment
percentages of patients having >50% reductions in 24-hour average pain severity during the first week
Time frame: during the first week
the 12-item Short-Form Health Survey (SF-12) score
Time frame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
the Pittsburgh Sleep Quality Index (PSQI) score
Time frame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
the Patient Global Impression of Change scale (PGIC)
Time frame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
The Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
Averaged weekly analgesic consumption
Time frame: 1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment
Safety assessments
Time frame: 0 day, 1 day, 3 days, 7 days, 2 weeks,3 weeks, and 1 month after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No. Not yet decided
Related trials for Postherpetic Neuralgia
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Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fang Luo, M.D. principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esketamine group in people with Postherpetic Neuralgia, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo, M.D. (+86 13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the mean of daily pain scores (time frame: during 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.