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

Phase 3

Completed

• Conditions: Pain of Mononeuropathy
• Interventions: Drug: GLA5PR GLARS-NF1; Drug: GLA5PR GLARS-NF1 placebo; Drug: Pregabalin placebo; Drug: Pregabalin

• Registration Number: NCT03221907
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-11
• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-17
• Study First Posted: 2017-07-19
• Primary Completion: 2019-01-08
• Study Completion: 2019-01-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-17
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLA5PR GLARS-NF1 & Pregabalin placebo	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
GLA5PR GLARS-NF1 & Pregabalin placebo	GLA5PR GLARS-NF1	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
GLA5PR GLARS-NF1 placebo & Pregabalin	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
GLA5PR GLARS-NF1 placebo & Pregabalin	GLA5PR GLARS-NF1 placebo	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

Primary Outcome Measures

Name	Time	Method
Daily Pain Rating Scale	12-week

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of