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NCT02985216 Clinical Trial

Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain

Peripheral Neuropathic Pain Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02985216
Other study ID # YHD1119-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 7, 2017
Est. completion date May 2, 2018

Study information
Verified date February 2017
Source Yuhan Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 371
Est. completion date May 2, 2018
Est. primary completion date April 27, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• YHD1119
YHD1119 150mg, PO YHD1119 300mg, PO YHD1119 600mg, PO
• Lyrica
Lyrica 75mg, PO Lyrica 150mg, PO Lyrica 300mg, PO

Locations
Country Name City State
Korea, Republic of Yong Chul Kim Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) Baseline, Day 85
Secondary Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) Day 1, 8, 15, 22, 29, 57, 85
Secondary Mean Pain Score on the Daily Pain Rating Scale at each visit Day 1, 8, 15, 22, 29, 57, 85
Secondary Patients proportion of reduction over 30% in Mean Pain Score from Baseline Day 1, 8, 15, 22, 29, 57, 85
Secondary 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
Secondary Patient Global Impression of Change (PGIC) Day 85
Secondary Clinical Global Impression of Change (CGIC) Day 85
Secondary SF-12 (Short form-12) Baseline, Day 85
Secondary C-SSRS (Columbia Suicide Severity Rating Scale) Baseline, Day 8, 29, 85
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