NCT05763550

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

A Multicenter, Randomized, Double-Blind, Double-Dummy , Pregaballin-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Herpetic Neuralgia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Herpetic Neuralgia

Interventions

Type	Name	Description
DRUG	HSK16149 20mg BID	HSK16149 20mg, orally twice a day, treatment period; 4-weeks fixed dose.
DRUG	HSK16149 40mg BID	HSK16149 40mg, orally twice a day, treatment period; 4-weeks fixed dose.
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

Timeline

• Start date: 2023-02-27
• Primary completion: 2023-06-22
• Completion: 2023-08-07
• First posted: 2023-03-10
• Last updated: 2023-11-08

Locations

1 site across 1 country: China