RecruitingPhase 2NCT06490484

Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin

Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin: A Prospective, Multicenter, Randomized, Double-Blind, Double-Dummy, Pregabalin-controlled Phase 2 Study


Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Enrollment

90 participants

Start Date

Apr 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Investigate the efficacy and safety of HSK16149 capsule in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) who had an inadequate response to Pregabalin, following 4 weeks treatment in comparison to Pregabalin


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HSK16149 20mg BID and a drug called Pregabalin 150mg BID for people with diabetic peripheral neuropathic pain. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHSK16149 20mg BID

Drug: HSK16149 20mg BID HSK16149 20mg, orally twice a day; treatment period: 4 weeks fixed dose.

DRUGPregabalin 150mg BID

Drug: Pregabalin 150mg BID Pregabalin 150mg, orally twice a day; treatment period: 1 week titration and 3 weeks fixed dose.


Locations(1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06490484


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