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Completed

NCT Number: NCT03341832

Efficacy and Safety of NVP-1203 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

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Key information

Conditions

Acute Low Back Pain

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Navipharm

Suwon, Gyeonggi-do, 16209, South Korea

About this study

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

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
  • 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

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. VAS Pain Intensity

    Time frame: 3, 7 days

    Improvement in VAS compared to baseline

Secondary outcomes

  1. Finger to Floor Distance (FFD)

    Time frame: 3, 7 days

    Improvement in FFD compared to baseline

  2. Oswestry Disability Index(ODI)

    Time frame: 3, 7 days

    Improvement in ODI compared to baseline

  3. Investigator Global Assessment of Response to Therapy(IGART)

    Time frame: 7 days

    Improvement in IGART compared to baseline

Sponsors and collaborators

Lead sponsor

NVP Healthcare

Industry

Registry information

Official study title

A Randomized, Double-blind, Active- and Placebo-controlled, Parallel, Multicenter, Phase II an Exploratory Clinical Trial to Evaluate the Efficacy and Safety NVP-1203 in Patients With Acute Low Back Pain

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2017
Registry last updated
Sep 18, 2019

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.

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