Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-28 @ 12:13 AM
Study NCT ID:
NCT06896994
Status:
RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051474', 'term': 'Neuralgia, Postherpetic'}], 'ancestors': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-20', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the mean of daily pain scores', 'timeFrame': 'during 1 week', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Averaged weekly NRS score', 'timeFrame': '1 week, 2 weeks, 3 weeks, and 1 month after treatment', 'description': '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'}, {'measure': 'percentages of patients having >50% reductions in 24-hour average pain severity during the first week', 'timeFrame': 'during the first week', 'description': 'percentages of patients having \\>50% reductions'}, {'measure': 'the 12-item Short-Form Health Survey (SF-12) score', 'timeFrame': '1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment', 'description': 'Quality of life (QoL) assessed by the SF-12 score (range 0-100, with higher scores indicating better health status).'}, {'measure': 'the Pittsburgh Sleep Quality Index (PSQI) score', 'timeFrame': '1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment', 'description': 'Sleep quality measured by PSQI score (range 0-21, with higher scores indicating poorer sleep quality).'}, {'measure': 'the Patient Global Impression of Change scale (PGIC)', 'timeFrame': '1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment', 'description': 'The proportion of patients with a response of "no change", "minimally improved", "much improved" or "very much improved" on PGIC.'}, {'measure': 'The Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment', 'description': '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.'}, {'measure': 'Averaged weekly analgesic consumption', 'timeFrame': '1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment', 'description': 'Averaged weekly consumption per analgesic of each participant'}, {'measure': 'Safety assessments', 'timeFrame': '0 day, 1 day, 3 days, 7 days, 2 weeks,3 weeks, and 1 month after treatment', 'description': 'drug-related complications,such as dizziness, somnolence, gait disturbance, nausea, fatigue, diarrhea, dry mouth, mental symptom, etc'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postherpetic Neuralgia', 'esketamine'], 'conditions': ['Postherpetic Neuralgia']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages more than 18 years;\n2. Pain present for more than 3 months after healing of a herpes zoster skin rash;\n3. Has an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0= no pain, 10= worst possible pain)；\n4. Failed to respond to or tolerate the effective dose of pregabalin monotherapy.\n\nExclusion Criteria:\n\n1. Obstructive sleep apnoea syndrome;\n2. Those who receive interventional treatments;\n3. A history of systemic immune diseases, organ transplantation, or cancers;\n4. A history of severe cardiopulmonary, hepatic or renal dysfunction;\n5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;\n6. Currently using monoamine oxidase inhibitors (MAOIs);\n7. Having untreated angle-closure glaucoma;\n8. Those suffering from increased intracranial pressure；\n9. Comorbid hyperthyroidism or phaeochromocytoma;\n10. Suspected or confirmed history of drug abuse;\n11. Having contraindications to esketamine, pregabaline or duloxetine;\n12. Communication difficulties;\n13. Women who are preparing for pregnancy, in the pregnancy or lactation period.'}, 'identificationModule': {'nctId': 'NCT06896994', 'briefTitle': 'Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Intravenous Infusion of Esketamine in Combination With Pregabalin and Duloxetine for Postherpetic Neuralgia', 'orgStudyIdInfo': {'id': 'KY-2024-332-02-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the esketamine group', 'description': "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.", 'interventionNames': ['Drug: esketamine group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'the control group', 'description': '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.', 'interventionNames': ['Drug: control group']}], 'interventions': [{'name': 'esketamine group', 'type': 'DRUG', 'otherNames': ['pregabalin+duloxetine+esketamine'], 'description': 'In the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine.', 'armGroupLabels': ['the esketamine group']}, {'name': 'control group', 'type': 'DRUG', 'otherNames': ['pregabalin+duloxetine'], 'description': 'receiving the combination of pregabalin and duloxetine', 'armGroupLabels': ['the control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Luo, M.D.', 'role': 'CONTACT', 'email': '13611326978@163.com', 'phone': '+86 13611326978'}], 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Fang Luo, M.D.', 'role': 'CONTACT', 'email': '13611326978@163.com', 'phone': '+86 13611326978'}], 'overallOfficials': [{'name': 'Fang Luo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not yet decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Xiaotangshan Hospital', 'class': 'OTHER'}, {'name': 'The First Hospital of Fangshan District,Beijing', 'class': 'OTHER'}, {'name': 'Beijing Ditan Hospital', 'class': 'OTHER'}, {'name': "Hengshui People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The Director of Department of Pain Management', 'investigatorFullName': 'Fang Luo', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}