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
Overview
- Phase
- Phase 3
- Intervention
- GLA5PR GLARS-NF1
- Conditions
- Pain of Mononeuropathy
- Sponsor
- Daewon Pharmaceutical Co., Ltd.
- Enrollment
- 352
- Locations
- 1
- Primary Endpoint
- Daily Pain Rating Scale
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
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
Arms & Interventions
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
Intervention: GLA5PR GLARS-NF1
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
Intervention: Pregabalin placebo
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
Intervention: GLA5PR GLARS-NF1 placebo
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
Intervention: Pregabalin
Outcomes
Primary Outcomes
Daily Pain Rating Scale
Time Frame: 12-week