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

NVP Healthcare421 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-controlled, parallel, phase 3 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

421

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 * 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

Locations (1)

Navipharm

Suwon, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Day 7

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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)

Time frame: 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).

Time frame: Baseline and Day 7

Data from ClinicalTrials.gov

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