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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03221907

Enrollment

352

Registered

2017-07-19

Start date

2016-04-11

Completion date

2019-01-08

Last updated

2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain of Mononeuropathy

Brief summary

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

Interventions

DRUGGLA5PR GLARS-NF1

Pregabalin tablet

DRUGGLA5PR GLARS-NF1 placebo

tablet manufactured to mimic GLA5PR GLARS-NF1

DRUGPregabalin

Pregabalin capsule

DRUGPregabalin placebo

tablet manufactured to mimic pregabalin capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Daily Pain Rating Scale	12-week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026