Skip to main content
OpenTrials
Completed

NCT Number: NCT04082975

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

The purpose of this study is to evaluate the efficacy and safety NVP-1203 in patients with acute low back pain.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Low Back Pain

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Navipharm

Suwon, Gyeonggi-do, 16209, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NVP-1203

Drug

Oral dose for 7 days

NVP-1203-R

Drug

Oral dose for 7 days

NVP-1203 placebo

Drug

Oral dose for 7 days

NVP-1203-R placebo

Drug

Oral dose for 7 days

Primary outcomes

  1. Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)

    Time frame: 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 outcomes

  1. Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)

    Time frame: 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.

  2. Change from baseline in Finger to Floor Distance(FFD)

    Time frame: 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.

  3. Change from baseline in Oswestry Disability Index(ODI)

    Time frame: 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)

  4. Change from baseline in Physician's Global Assessment of Response to Therapy(PGART)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

NVP Healthcare

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2019
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.