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

Study Overview
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Brief Summary
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Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.

Official Title
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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

Conditions
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Herpetic Neuralgia

Intervention / Treatment
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* Drug: HSK16149 20mg BID
* Drug: HSK16149 40mg BID
* Drug: Pregabalin 150mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent; Males or females aged 18 years and older ; Patients must have herpetic neuralgia; At Screening, pain scale (VAS) of ≥ 40 mm; At Screening, pain scale (NRS) of ≥ 4. Exclusion Criteria: Patients have pain present for more than 1 months after the healing of the herpes zoster skin rash; AST/ALT > 2 × upper limit of normal (ULN), or TBIL≥1.5 × ULN; Serum Creatine > 176μmol/L; Any active infections at screening; History of allergic or medically significant adverse reaction to investigational products or their excipients, pregabalin or related compounds; Participated in another clinical study within 30 days prior to screening; Pregnant or breastfeeding at screening ; Other conditions unlikely to participate in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSK16149 20mg BID<br> | Drug: HSK16149 20mg BID<br>* HSK16149 20mg, orally twice a day, treatment period; 4-weeks fixed dose.<br>|
| Experimental: HSK16149 40mg BID<br> | Drug: HSK16149 40mg BID<br>* HSK16149 40mg, orally twice a day, treatment period; 4-weeks fixed dose.<br>|
| Active Comparator: Pregabalin 150mg BID<br> | Drug: Pregabalin 150mg<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4 | Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0[no pain] to 10 [worst possible pain] | Baseline and week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the response rate between HSK16149 and pregabalin at week 4 (Proportion of subjects whose NRS decreased by ≥30% and≥ 50% from baseline ) |  | Baseline and week 4 | 
| Compare the change from baseline in VAS between HSK16149 and pregabalin at week 4 | 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 | Baseline and week 4 | 
| Compare the change from baseline in DSIS between HSK16149 and pregabalin at week 4 | 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. | Baseline and week 4 |