Herpetic Neuralgia
Conditions
Brief summary
Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.
Interventions
HSK16149 20mg, orally twice a day, treatment period; 4-weeks fixed dose.
HSK16149 40mg, orally twice a day, treatment period; 4-weeks fixed dose.
DRUGPregabalin 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
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed