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

March 17, 2019 updated by: Daewon Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

352

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Drug: GLA5PR GLARS-NF1
Pregabalin tablet
Drug: Pregabalin placebo
tablet manufactured to mimic pregabalin capsule
Other Names:
  • placebo (for pregablin)
ACTIVE_COMPARATOR: 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
Drug: GLA5PR GLARS-NF1 placebo
tablet manufactured to mimic GLA5PR GLARS-NF1
Other Names:
  • placebo (for GLA5PR GLARS-NF1)
Drug: Pregabalin
Pregabalin capsule
Other Names:
  • Lyrica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Daily Pain Rating Scale
Time Frame: 12-week
12-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 11, 2016

Primary Completion (ACTUAL)

January 8, 2019

Study Completion (ACTUAL)

January 8, 2019

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (ACTUAL)

July 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 17, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW1502-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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