Back to resultsClinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain
Primary Purpose
Peripheral Neuropathic Pain
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YHD1119
Lyrica
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathic Pain
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
Sites / Locations
- Yong Chul Kim
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
YHD1119
Lyrica
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
Secondary Outcome Measures
Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)
Mean Pain Score on the Daily Pain Rating Scale at each visit
Patients proportion of reduction over 30% in Mean Pain Score from Baseline
Change of duration-modification from baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)
Patient Global Impression of Change (PGIC)
Clinical Global Impression of Change (CGIC)
SF-12 (Short form-12)
C-SSRS (Columbia Suicide Severity Rating Scale)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02985216
Brief Title
Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
April 27, 2018 (Actual)
Study Completion Date
May 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
371 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YHD1119
Arm Type
Experimental
Arm Description
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.
Arm Title
Lyrica
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
YHD1119
Other Intervention Name(s)
Pregabalin
Intervention Description
YHD1119 150mg, PO YHD1119 300mg, PO
YHD1119 600mg, PO
Intervention Type
Drug
Intervention Name(s)
Lyrica
Other Intervention Name(s)
Pregabalin
Intervention Description
Lyrica 75mg, PO Lyrica 150mg, PO Lyrica 300mg, PO
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)
Time Frame
Day 1, 8, 15, 22, 29, 57, 85
Title
Mean Pain Score on the Daily Pain Rating Scale at each visit
Time Frame
Day 1, 8, 15, 22, 29, 57, 85
Title
Patients proportion of reduction over 30% in Mean Pain Score from Baseline
Time Frame
Day 1, 8, 15, 22, 29, 57, 85
Title
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
Title
Patient Global Impression of Change (PGIC)
Time Frame
Day 85
Title
Clinical Global Impression of Change (CGIC)
Time Frame
Day 85
Title
SF-12 (Short form-12)
Time Frame
Baseline, Day 85
Title
C-SSRS (Columbia Suicide Severity Rating Scale)
Time Frame
Baseline, Day 8, 29, 85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Chul KIM, M.D.,Ph.D.
Organizational Affiliation
Seoul National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yong Chul Kim
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain
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