Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain

Yuhan

Status and phase: Completed; Phase 3

Conditions: Peripheral Neuropathic Pain

Treatments: Drug: Lyrica; Drug: YHD1119

Study type: Interventional

Funder types: Industry

Identifiers

NCT02985216

YHD1119-301

Details and patient eligibility

About

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

Enrollment: 371 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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371 participants in 2 patient groups

YHD1119

Experimental group

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.

Treatment:

Drug: YHD1119

Lyrica

Active Comparator group

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.

Treatment:

Drug: Lyrica