Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-29 @ 12:46 PM
Study NCT ID:
NCT05763550
Status:
COMPLETED
Last Update Posted:
2023-11-08
First Post:
2023-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C494814', 'term': 'BID protein, human'}, {'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4', 'timeFrame': 'Baseline and week 4', 'description': 'Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0\\[no pain\\] to 10 \\[worst possible pain\\]'}], 'secondaryOutcomes': [{'measure': 'Compare the response rate between HSK16149 and pregabalin at week 4 (Proportion of subjects whose NRS decreased by ≥30% and≥ 50% from baseline )', 'timeFrame': 'Baseline and week 4'}, {'measure': 'Compare the change from baseline in VAS between HSK16149 and pregabalin at week 4', 'timeFrame': 'Baseline and week 4', 'description': 'VAS, in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain'}, {'measure': 'Compare the change from baseline in DSIS between HSK16149 and pregabalin at week 4', 'timeFrame': 'Baseline and week 4', 'description': 'The sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Herpetic Neuralgia']}, 'descriptionModule': {'briefSummary': 'Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent;\n* Males or females aged 18 years and older ;\n* Patients must have herpetic neuralgia;\n* At Screening, pain scale (VAS) of ≥ 40 mm;\n* At Screening, pain scale (NRS) of ≥ 4.\n\nExclusion Criteria:\n\n* Patients have pain present for more than 1 months after the healing of the herpes zoster skin rash;\n* AST/ALT \\> 2 × upper limit of normal (ULN), or TBIL≥1.5 × ULN;\n* Serum Creatine \\> 176μmol/L;\n* Any active infections at screening;\n* History of allergic or medically significant adverse reaction to investigational products or their excipients, pregabalin or related compounds;\n* Participated in another clinical study within 30 days prior to screening;\n* Pregnant or breastfeeding at screening ;\n* Other conditions unlikely to participate in this trial.'}, 'identificationModule': {'nctId': 'NCT05763550', 'briefTitle': 'To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Haisco Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Double-Dummy , Pregaballin-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Herpetic Neuralgia', 'orgStudyIdInfo': {'id': 'HSK16149-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HSK16149 20mg BID', 'interventionNames': ['Drug: HSK16149 20mg BID']}, {'type': 'EXPERIMENTAL', 'label': 'HSK16149 40mg BID', 'interventionNames': ['Drug: HSK16149 40mg BID']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin 150mg BID', 'interventionNames': ['Drug: Pregabalin 150mg']}], 'interventions': [{'name': 'HSK16149 20mg BID', 'type': 'DRUG', 'description': 'HSK16149 20mg, orally twice a day, treatment period; 4-weeks fixed dose.', 'armGroupLabels': ['HSK16149 20mg BID']}, {'name': 'HSK16149 40mg BID', 'type': 'DRUG', 'description': 'HSK16149 40mg, orally twice a day, treatment period; 4-weeks fixed dose.', 'armGroupLabels': ['HSK16149 40mg BID']}, {'name': 'Pregabalin 150mg', 'type': 'DRUG', 'description': 'pregabalin, orally twice a day, treatment period; 150 mg (75 mg twice daily) for 1 week；300 mg (150 mg twice daily) daily for 3 week', 'armGroupLabels': ['Pregabalin 150mg BID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Fangqiong Li', 'role': 'STUDY_CHAIR', 'affiliation': 'Haisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haisco Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}