To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia
Study Details
Study Description
Brief Summary
Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HSK16149 20mg BID
|
Drug: HSK16149 20mg BID
HSK16149 20mg, orally twice a day, treatment period; 4-weeks fixed dose.
|
| Experimental: HSK16149 40mg BID
|
Drug: HSK16149 40mg BID
HSK16149 40mg, orally twice a day, treatment period; 4-weeks fixed dose.
|
| Active Comparator: Pregabalin 150mg BID
|
Drug: Pregabalin 150mg
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
|
Outcome Measures
Primary Outcome Measures
- Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4 [Baseline and week 4]
Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0[no pain] to 10 [worst possible pain]
Secondary Outcome Measures
- 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 [Baseline and 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
- Compare the change from baseline in DSIS between HSK16149 and pregabalin at week 4 [Baseline and 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed informed consent;
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Males or females aged 18 years and older ;
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Patients must have herpetic neuralgia;
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At Screening, pain scale (VAS) of ≥ 40 mm;
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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;
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Serum Creatine > 176μmol/L;
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Any active infections at screening;
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History of allergic or medically significant adverse reaction to investigational products or their excipients, pregabalin or related compounds;
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Participated in another clinical study within 30 days prior to screening;
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Pregnant or breastfeeding at screening ;
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Other conditions unlikely to participate in this trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China | 430000 |
Sponsors and Collaborators
- Haisco Pharmaceutical Group Co., Ltd.
Investigators
- Study Chair: Fangqiong Li, Haisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSK16149-205