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OpenTrials
Completed

NCT Number: NCT03221907

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

Completed

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Key information

Conditions

Pain of Mononeuropathy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLA5PR GLARS-NF1

Drug

Pregabalin tablet

GLA5PR GLARS-NF1 placebo

Drug

tablet manufactured to mimic GLA5PR GLARS-NF1

Other names: placebo (for GLA5PR GLARS-NF1)

Pregabalin

Drug

Pregabalin capsule

Other names: Lyrica

Pregabalin placebo

Drug

tablet manufactured to mimic pregabalin capsule

Other names: placebo (for pregablin)

Primary outcomes

  1. Daily Pain Rating Scale

    Time frame: 12-week

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 19, 2017
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.