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Completed

NCT Number: NCT02985216

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

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Key information

Conditions

Peripheral Neuropathic Pain

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yong Chul Kim

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YHD1119

Drug

YHD1119 150mg, PO YHD1119 300mg, PO

YHD1119 600mg, PO

Other names: Pregabalin

lyrica

Drug

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

Other names: Pregabalin

Primary outcomes

  1. 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 outcomes

  1. Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)

    Time frame: Day 1, 8, 15, 22, 29, 57, 85

  2. Mean Pain Score on the Daily Pain Rating Scale at each visit

    Time frame: Day 1, 8, 15, 22, 29, 57, 85

  3. Patients proportion of reduction over 30% in Mean Pain Score from Baseline

    Time frame: Day 1, 8, 15, 22, 29, 57, 85

  4. 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

  5. Patient Global Impression of Change (PGIC)

    Time frame: Day 85

  6. Clinical Global Impression of Change (CGIC)

    Time frame: Day 85

  7. SF-12 (Short form-12)

    Time frame: Baseline, Day 85

  8. C-SSRS (Columbia Suicide Severity Rating Scale)

    Time frame: Baseline, Day 8, 29, 85

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 7, 2016
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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