Clinical Trial of YHD1119 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
1 other identifier
interventional
371
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2017
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 7, 2016
CompletedStudy Start
First participant enrolled
February 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2018
CompletedJanuary 16, 2019
February 1, 2017
1.2 years
December 1, 2016
January 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
Baseline, Day 85
Secondary Outcomes (8)
Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)
Day 1, 8, 15, 22, 29, 57, 85
Mean Pain Score on the Daily Pain Rating Scale at each visit
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
- +3 more secondary outcomes
Study Arms (2)
YHD1119
EXPERIMENTALYHD1119 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
ACTIVE COMPARATORLyrica 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have Brittle diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yong Chul Kim
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong Chul KIM, M.D.,Ph.D.
Seoul National University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2016
First Posted
December 7, 2016
Study Start
February 7, 2017
Primary Completion
April 27, 2018
Study Completion
May 2, 2018
Last Updated
January 16, 2019
Record last verified: 2017-02