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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-11

Study Completion Date

2019-01-08

Brief Summary

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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

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Detailed Description

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Conditions

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Pain of Mononeuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GLA5PR GLARS-NF1 & Pregabalin placebo

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

Group Type EXPERIMENTAL

GLA5PR GLARS-NF1

Intervention Type DRUG

Pregabalin tablet

Pregabalin placebo

Intervention Type DRUG

tablet manufactured to mimic pregabalin capsule

GLA5PR GLARS-NF1 placebo & Pregabalin

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

Group Type ACTIVE_COMPARATOR

GLA5PR GLARS-NF1 placebo

Intervention Type DRUG

tablet manufactured to mimic GLA5PR GLARS-NF1

Pregabalin

Intervention Type DRUG

Pregabalin capsule

Interventions

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GLA5PR GLARS-NF1

Pregabalin tablet

Intervention Type DRUG

GLA5PR GLARS-NF1 placebo

tablet manufactured to mimic GLA5PR GLARS-NF1

Intervention Type DRUG

Pregabalin

Pregabalin capsule

Intervention Type DRUG

Pregabalin placebo

tablet manufactured to mimic pregabalin capsule

Intervention Type DRUG

Other Intervention Names

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placebo (for GLA5PR GLARS-NF1) Lyrica placebo (for pregablin)

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No