Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain

January 14, 2019 updated by: Yuhan Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

371

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: YHD1119

YHD1119 150mg, PO YHD1119 300mg, PO

YHD1119 600mg, PO

Other Names:
  • Pregabalin
ACTIVE_COMPARATOR: 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.
Drug: Lyrica
Lyrica 75mg, PO Lyrica 150mg, PO Lyrica 300mg, PO
Other Names:
  • Pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, Day 85

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Investigators

  • Principal Investigator: Yong Chul KIM, M.D.,Ph.D., Seoul National University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 7, 2017

Primary Completion (ACTUAL)

April 27, 2018

Study Completion (ACTUAL)

May 2, 2018

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (ESTIMATE)

December 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YHD1119-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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