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The purpose of this study is to evaluate the efficacy and safety NVP-1203 in patients with Acute low back pain
This study is a randomized, double-blind, active- and placebo-controlled, parallel, phase II study to evaluate efficacy and safety of NVP-1203 in patients with Acute low back pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVP-1203 | Experimental | NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose |
|
| NVP-1203-R | Active Comparator | NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose |
|
| Placebo | Placebo Comparator | NVP-1203 placebo plus NVP-1203-R placebo for up to 7 days, oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVP-1203 | Drug | oral dose for 7 days |
| |
| NVP-1203-R |
| Measure | Description | Time Frame |
|---|---|---|
| VAS Pain Intensity | Improvement in VAS compared to baseline | 3, 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Finger to Floor Distance (FFD) | Improvement in FFD compared to baseline | 3, 7 days |
| Oswestry Disability Index(ODI) | Improvement in ODI compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seong-Hwan Moon, MD | Severance Hospital | Principal Investigator |
| Jin Hwan Kim, MD | Inje University | Principal Investigator |
| Tae Kyun Kim, MD | Wonkwang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navipharm | Suwon | Gyeonggi-do | 16209 | South Korea |
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| Drug |
oral dose for 7 days |
|
| NVP-1203 placebo | Drug | oral dose for 7 days |
|
| NVP-1203-R placebo | Drug | oral dose for 7 days |
|
| 3, 7 days |
| Investigator Global Assessment of Response to Therapy(IGART) | Improvement in IGART compared to baseline | 7 days |