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

• Status: Recruiting
• Trial end date: 2023-07-10
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.
• Treatments: Pregabalin

Criteria

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.