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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-controlled, parallel, phase 3 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVP-1203 | Drug | Oral dose for 7 days |
| |
| NVP-1203-R |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS) | Pain intensity is assessed by 100 mm Visual Analogue Scale(VAS) (0 mm = no pain and 100 mm = maximum pain) evaluated from baseline to Day 7. | Baseline and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS) | Pain intensity is assessed by 100 mm Visual Analogue Scale(VAS) (0 mm = no pain and 100 mm = maximum pain) evaluated from baseline to Day 3. | Baseline and Day 3 |
| Change from baseline in Finger to Floor Distance(FFD) |
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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 |
|
FFD is measured by the Investigators who will ask the patients to bend forward and try to touch the floor with the fingers. The distance between the finger to the floor is measured in cm. |
| Baseline, Day 3 and Day 7 |
| Change from baseline in Oswestry Disability Index(ODI) | The questionnaire consists of 10 items with each item having 6 answers associated to activities of daily living. The ODI score range is 0 to 100% (low score: minimal disability, high score: bed-bound or exaggerating) | Baseline, Day 3 and Day 7 |
| Change from baseline in Physician's Global Assessment of Response to Therapy(PGART) | Physician's response of change after administration is assessed on 5-point rating scales(very poor, poor, no change, good and very good). | Baseline and Day 7 |