Loading clinical trials...

To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Postherpetic Neuralgia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Postherpetic Neuralgia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week, Phase 3 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Postherpetic Neuralgia

NCT05140863•Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

Investigate the Efficacy and Safety of HSK16149 capsules in Chinese Postherpetic Neuralgia Following 12 Weeks Treatment in Comparison to Placebo

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent;
•2. Males or females aged 18-75 years of age inclusive;
•3. Outpatient, Patients can not stay in the hospital overnight;
•4. Patients must have pain present for more than 1 months after the healing of the herpes zoster skin rash;
•5. At Screening, pain scale (VAS) of ≥40 mm;

Exclusion Criteria

•1. Peripheral neuropathy or pain unrelated to PHN that may confuse the assessment of PHN;
•2. Skin conditions in the area affected by neurupathy that could alter sensation;
•3. Chronic systemic diseases that may affect subjects' participation in the study;
•4. Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:1)Neutrophils \< 1.5 × 109/L, or platelet \< 90 × 109/L, or hemoglobin \< 100 g/L, or 2)AST/ALT \> 2.5 × upper limit of normal (ULN), or TBIL \> 1.5 × ULN, or 3)Estimation of glomerular filtration rate (eGFR) \< 60 mL/min / 1.73 m2, or 4)Creatine kinase \> 2.0 × ULN.
•5. Uncontrolled diabetes(HbA1c≥11.0% at screening) ;
•6. History of substance abuse or alcohol abuse;
•7. Any active infections at screening;
•8. HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive;
•9. Inability or unwillingness to discontinue any other prohibited concomitant medications (see Section 6.3);
•10. Patients who have undergone neurolytic or neurosurgical therapy 1 week before screening for postherpetic neuralgia;
+7 more criteria

Locations (2)

Dermatology Hospital of Chinese Academy of Medical Sciences

Nanjing, Jiangsu, China

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Key Dates

Start Date

November 1, 2021

Primary Completion Date

December 22, 2022

Completion Date

January 5, 2023

Last Updated

February 27, 2023

Enrollment

372

ACTUAL participants

Conditions

Postherpetic Neuralgia

Interventions

HSK16149 20mg BID

DRUG

HSK16149 40mg BID

DRUG

Placebo BID

DRUG

The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia.

NCT07000409

Postherpetic NeuralgiaChronic Pain+3 more

View study

RECRUITINGNA

Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia

NCT06896994

Postherpetic Neuralgia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Postherpetic Neuralgia

Inclusion Criteria

Exclusion Criteria

The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia.

Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia

Relationship Between Serum Vitamin D Levels and Postherpetic Neuralgia.

Dorsal Root Ganglion Stimulation in Postherpetic Neuropathy

Predictors of Success After Intercostal Nerve Radiofrequency Treatment for Intercostal Neuralgia

Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia