Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLA5PR GLARS-NF1 & Pregabalin placebo | Experimental | 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 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLA5PR GLARS-NF1 | Drug | Pregabalin tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Pain Rating Scale | 12-week |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33272643 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| GLA5PR GLARS-NF1 placebo |
| Drug |
tablet manufactured to mimic GLA5PR GLARS-NF1 |
|
|
| Pregabalin | Drug | Pregabalin capsule |
|
|
| Pregabalin placebo | Drug | tablet manufactured to mimic pregabalin capsule |
|
|
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |