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

NCT06490484 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-07-08

No results posted yet for this study

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

Conditions

  • Diabetic Peripheral Neuropathic Pain

Interventions

DRUG

HSK16149 20mg BID

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

DRUG

Pregabalin 150mg BID

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

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-19
Primary Completion
2024-07-12
Completion
2024-07-14

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06490484 on ClinicalTrials.gov