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

NVP Healthcare91 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Acute Low Back Pain

Interventions

NVP-1203DRUG

oral dose for 7 days

NVP-1203-RDRUG

oral dose for 7 days

NVP-1203 placeboDRUG

oral dose for 7 days

NVP-1203-R placebo

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Navipharm

Suwon, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

VAS Pain Intensity

Improvement in VAS compared to baseline

Time frame: 3, 7 days

Secondary Outcomes

Finger to Floor Distance (FFD)

Improvement in FFD compared to baseline

Time frame: 3, 7 days

Oswestry Disability Index(ODI)

Improvement in ODI compared to baseline

Time frame: 3, 7 days

Investigator Global Assessment of Response to Therapy(IGART)

Improvement in IGART compared to baseline

Time frame: 7 days

Data from ClinicalTrials.gov

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