Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain

A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy Between YHD1119 and Pregabalin in Patients With Peripheral Neuropathic Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02985216

Enrollment

371

Registered

2016-12-07

Start date

2017-02-07

Completion date

2018-05-02

Last updated

2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Neuropathic Pain

Brief summary

A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy between YHD1119 and Pregabalin in Patients with Peripheral Neuropathic Pain

Interventions

DRUGYHD1119

YHD1119 150mg, PO YHD1119 300mg, PO YHD1119 600mg, PO

DRUGLyrica

Lyrica 75mg, PO Lyrica 150mg, PO Lyrica 300mg, PO

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Signed Informed Consent * HbA1c ≤ 9.5% diabetes mellitus patients with pain over 6 months in Diabetic Peripheral Neuropathy or postherpetic Neuralgia patients at least 3 months pain after diagnosis of skin rash due to herpes zooster

Exclusion criteria

* Have Brittle diabetes mellitus

Design outcomes

Primary

Measure	Time frame
Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)	Baseline, Day 85

Secondary

Measure	Time frame
Mean Pain Score on the Daily Pain Rating Scale at each visit	Day 1, 8, 15, 22, 29, 57, 85
Patients proportion of reduction over 30% in Mean Pain Score from Baseline	Day 1, 8, 15, 22, 29, 57, 85
Change of duration-modification from baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)	Day 1, 8, 15, 22, 29, 57, 85
Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)	Day 1, 8, 15, 22, 29, 57, 85
Clinical Global Impression of Change (CGIC)	Day 85
SF-12 (Short form-12)	Baseline, Day 85
C-SSRS (Columbia Suicide Severity Rating Scale)	Baseline, Day 8, 29, 85
Patient Global Impression of Change (PGIC)	Day 85

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026