Pain of Mononeuropathy Clinical Trial
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
| Verified date | March 2019 |
| Source | Daewon Pharmaceutical Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 352 |
| Est. completion date | January 8, 2019 |
| Est. primary completion date | January 8, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Daewon Pharmaceutical Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Daily Pain Rating Scale | 12-week |