NCT04647773

To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Pregabalin Capsule-Controlled, 13-Week, Adaptive-design Phase 2/3 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Diabetic Peripheral Neuropathic Pain

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 687 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Investigate the efficacy and safety of HSK16149 capsules in Chinese diabetic peripheral neuropathic pain (DPNP) following 13 weeks treatment in comparison to placebo.

Conditions

• Diabetic Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	HSK16149 20mg BID	HSK16149 20mg, orally twice a day, treatment period; 13-weeks fixed dose.
DRUG	HSK16149 40mg BID	HSK16149 40mg, orally twice a day, treatment period; 13-weeks fixed dose.
DRUG	HSK16149 60mg BID	HSK16149 60mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
DRUG	HSK16149 80mg BID	HSK16149 80mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
DRUG	Pregabalin 150mg BID	Pregabalin 150mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
DRUG	Placebo BID	Placebo, orally twice a day, treatment period; 13-weeks fixed dose.

Timeline

• Start date: 2020-12-02
• Primary completion: 2022-11-09
• Completion: 2022-11-16
• First posted: 2020-12-01
• Last updated: 2020-12-01

Locations

1 site across 1 country: China