Efficacy and Safety of NVP-1203 and NVP-1203-R in Patients With Acute Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double-blind, Active Controlled, Parallel, Multicenter, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of NVP-1203 in Patients With Acute Low Back Pain

Conditions
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Acute Low Back Pain

Intervention / Treatment
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* Drug: NVP-1203
* Drug: NVP-1203-R
* Drug: NVP-1203 placebo
* Drug: NVP-1203-R placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing Subjects who have symptom of acute low back pain Exclusion Criteria: Subjects who cannot prohibit anti-inflammatory drug or muscle relaxants during clinical trial Inadequate subject for the clinical trial by the investigator's decision

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVP-1203<br>NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose | Drug: NVP-1203<br>* Oral dose for 7 days<br>Drug: NVP-1203-R placebo<br>* Oral dose for 7 days<br>|
| Active Comparator: NVP-1203-R<br>NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose | Drug: NVP-1203-R<br>* Oral dose for 7 days<br>Drug: NVP-1203 placebo<br>* Oral dose for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |