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

Yuhan Corporation1 site in 1 country371 target enrollmentFebruary 7, 2017

ConditionsPeripheral Neuropathic Pain

InterventionsYHD1119 Lyrica

DrugsYHD1119 Lyrica

Overview

Phase: Phase 3
Intervention: YHD1119
Conditions: Peripheral Neuropathic Pain
Sponsor: Yuhan Corporation
Enrollment: 371
Locations: 1
Primary Endpoint: Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 7, 2017

End Date

May 2, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yuhan Corporation

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

YHD1119

YHD1119 150mg for the first 1 week, then forced titrated to YHD1119 300mg for the 1 week. And then YHD1119 150\~600mg for the 2 weeks, then YHD1119 fixed dose was administrated for 8 weeks.

Intervention: YHD1119

Lyrica

Lyrica 150mg for the first 1 week, then forced titrated to Lyrica 300mg for the 1 week. And then Lyrica 150\~600mg for the 2 weeks, then Lyrica fixed dose was administrated for 8 weeks.

Intervention: Lyrica

Outcomes

Primary Outcomes

Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)

Time Frame: Baseline, Day 85

Secondary Outcomes

Clinical Global Impression of Change (CGIC)(Day 85)
Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)(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)
Patient Global Impression of Change (PGIC)(Day 85)
Mean Pain Score on the Daily Pain Rating Scale at each visit(Day 1, 8, 15, 22, 29, 57, 85)
SF-12 (Short form-12)(Baseline, Day 85)
C-SSRS (Columbia Suicide Severity Rating Scale)(Baseline, Day 8, 29, 85)