Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain

NCT ID: NCT02985216

Last Updated: 2019-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

371 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-07

Study Completion Date

2018-05-02

Brief Summary

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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

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Conditions

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Peripheral Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

YHD1119

Intervention Type DRUG

YHD1119 150mg, PO YHD1119 300mg, PO

YHD1119 600mg, PO

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.

Group Type ACTIVE_COMPARATOR

Lyrica

Intervention Type DRUG

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

Interventions

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YHD1119

YHD1119 150mg, PO YHD1119 300mg, PO

YHD1119 600mg, PO

Intervention Type DRUG

Lyrica

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

Intervention Type DRUG

Other Intervention Names

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Pregabalin Pregabalin

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yong Chul KIM, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University

Locations

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Yong Chul Kim

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YHD1119-301

Identifier Type: -

Identifier Source: org_study_id

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