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

Primary Purpose

Pain of Mononeuropathy

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GLA5PR GLARS-NF1
GLA5PR GLARS-NF1 placebo
Pregabalin
Pregabalin placebo
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain of Mononeuropathy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GLA5PR GLARS-NF1 & Pregabalin placebo

GLA5PR GLARS-NF1 placebo & Pregabalin

Arm Description

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 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

Outcomes

Primary Outcome Measures

Daily Pain Rating Scale

Secondary Outcome Measures

Full Information

First Posted
July 11, 2017
Last Updated
March 17, 2019
Sponsor
Daewon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03221907
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of 'GLA5PR GLARS-NF1 Tab.' in Peripheral Neuropathic Pain
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 11, 2016 (Actual)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
January 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain of Mononeuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLA5PR GLARS-NF1 & Pregabalin placebo
Arm Type
Experimental
Arm Description
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
Arm Title
GLA5PR GLARS-NF1 placebo & Pregabalin
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
GLA5PR GLARS-NF1
Intervention Description
Pregabalin tablet
Intervention Type
Drug
Intervention Name(s)
GLA5PR GLARS-NF1 placebo
Other Intervention Name(s)
placebo (for GLA5PR GLARS-NF1)
Intervention Description
tablet manufactured to mimic GLA5PR GLARS-NF1
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
Pregabalin capsule
Intervention Type
Drug
Intervention Name(s)
Pregabalin placebo
Other Intervention Name(s)
placebo (for pregablin)
Intervention Description
tablet manufactured to mimic pregabalin capsule
Primary Outcome Measure Information:
Title
Daily Pain Rating Scale
Time Frame
12-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33272643
Citation
Lee MK, Jeon Y, Choi SS, Lee PB, Kim YC, Suh JH, Sim SE, Song SO, Ko Y, Yu JM, Min K, Lee JH. Efficacy and Safety of the Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and Immediate-release Pregabalin Capsule for Peripheral Neuropathic Pain: A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial. Clin Ther. 2020 Dec;42(12):2266-2279. doi: 10.1016/j.clinthera.2020.10.009. Epub 2020 Nov 30.
Results Reference
derived

Learn more about this trial

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

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