Acute Low Back Pain
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety NVP-1203 in patients with acute low back pain.
Detailed description
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.
Interventions
DRUGNVP-1203
Oral dose for 7 days
DRUGNVP-1203-R
Oral dose for 7 days
DRUGNVP-1203 placebo
Oral dose for 7 days
Oral dose for 7 days
Sponsors
NVP Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS) | Baseline and Day 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS) | Baseline and Day 3 | 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. |
| Change from baseline in Physician's Global Assessment of Response to Therapy(PGART) | Baseline and Day 7 | Physician's response of change after administration is assessed on 5-point rating scales(very poor, poor, no change, good and very good). |
| Change from baseline in Finger to Floor Distance(FFD) | Baseline, Day 3 and Day 7 | 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. |
| Change from baseline in Oswestry Disability Index(ODI) | Baseline, Day 3 and Day 7 | 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) |
Countries
South Korea
Outcome results
None listed