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Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK16149 20mg BID | Experimental |
| |
| HSK16149 40mg BID | Experimental |
| |
| Pregabalin 150mg BID | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK16149 20mg BID | Drug | HSK16149 20mg, orally twice a day, treatment period; 4-weeks fixed dose. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fangqiong Li | Haisco | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| HSK16149 40mg BID | Drug | HSK16149 40mg, orally twice a day, treatment period; 4-weeks fixed dose. |
|
| Pregabalin 150mg | Drug | 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 |
|
| 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 |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |