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

NCT04647773 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 687

Last updated 2020-12-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-02
Primary Completion
2022-11-09
Completion
2022-11-16

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 NCT04647773 on ClinicalTrials.gov