Clinical Trial to Evaluate the Efficacy and Safety of 'GLA5PR GLARS-NF1 Tab.' in Peripheral Neuropathic Pain

Daewon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Pain of Mononeuropathy

Treatments: Drug: Pregabalin; Drug: Pregabalin placebo; Drug: GLA5PR GLARS-NF1; Drug: GLA5PR GLARS-NF1 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03221907

DW1502-301

Details and patient eligibility

About

A multi-center, randomized, double-blind, parallel, active-controlled phase III clinical trial to evaluate the efficacy and safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in peripheral neuropathic pain

Enrollment: 352 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• both male and female who are over 19-year-old
• patient whose pain scale is 4~9
• patient who has pain of mononeuropathy

Exclusion criteria

• patient whose CCr is <60ml/min
• patient who has other pain which is not from mononeuropathy
• patient who is going to have an operation during this study
• patient who has abnormal ECG

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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352 participants in 2 patient groups

GLA5PR GLARS-NF1 & Pregabalin placebo

Experimental group

Description:

GLA5PR GLARS-NF1 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin placebo 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 months

Treatment:

Drug: Pregabalin placebo

Drug: GLA5PR GLARS-NF1

GLA5PR GLARS-NF1 placebo & Pregabalin

Active Comparator group

Description:

GLA5PR GLARS-NF1 placebo 150mg, 300mg tablet by mouth, every after dinner for about 3 months Pregabalin 75mg, 150mg, 300mg capsules by mouth, every after breakfast and dinner for about 3 months

Treatment:

Drug: GLA5PR GLARS-NF1 placebo

Drug: Pregabalin