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

Haisco Pharmaceutical Group

Status and phase: Completed; Phase 2

Conditions: Herpetic Neuralgia

Treatments: Drug: HSK16149 20mg BID; Drug: Pregabalin 150mg; Drug: HSK16149 40mg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT05763550

HSK16149-205

Details and patient eligibility

About

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

Enrollment: 331 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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331 participants in 3 patient groups

HSK16149 20mg BID

Experimental group

Treatment:

Drug: HSK16149 20mg BID

HSK16149 40mg BID

Experimental group

Treatment:

Drug: HSK16149 40mg BID

Pregabalin 150mg BID

Active Comparator group

Treatment:

Drug: Pregabalin 150mg