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- and placebo-controlled, parallel, phase II 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 * 19 Years and older * A patient has 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 |
|---|---|---|
| VAS Pain Intensity | 3, 7 days | Improvement in VAS compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Finger to Floor Distance (FFD) | 3, 7 days | Improvement in FFD compared to baseline |
| Oswestry Disability Index(ODI) | 3, 7 days | Improvement in ODI compared to baseline |
| Investigator Global Assessment of Response to Therapy(IGART) | 7 days | Improvement in IGART compared to baseline |
Countries
South Korea
Outcome results
None listed