Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain

Phase 3

Completed

• Conditions: Peripheral Neuropathic Pain
• Interventions: Drug: YHD1119; Drug: Lyrica

• Registration Number: NCT02985216
• Lead Sponsor: Yuhan Corporation

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-07
• Status Verified: 2017-02
• Study Start: 2017-02-07
• Primary Completion: 2018-04-27
• Study Completion: 2018-05-02
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 371

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YHD1119	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.
Lyrica	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yong Chul Kim; 🇰🇷 Seoul, Korea, Republic of