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Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT02985216
Recruitment Status : Completed
First Posted : December 7, 2016
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

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

Condition or disease Intervention/treatment Phase
Peripheral Neuropathic Pain Drug: YHD1119 Drug: Lyrica Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 371 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 7, 2017
Actual Primary Completion Date : April 27, 2018
Actual Study Completion Date : May 2, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

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 Name: 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 Name: Pregabalin




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985216


Locations
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Korea, Republic of
Yong Chul Kim
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Investigators
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Principal Investigator: Yong Chul KIM, M.D.,Ph.D. Seoul National University

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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT02985216     History of Changes
Other Study ID Numbers: YHD1119-301
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs