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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 24, 2021

Detailed Description

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.

Interventions

  • Drug: NVP-1203
    • Oral dose for 7 days
  • Drug: NVP-1203-R
    • Oral dose for 7 days
  • Drug: NVP-1203 placebo
    • Oral dose for 7 days
  • Drug: NVP-1203-R placebo
    • Oral dose for 7 days

Arms, Groups and Cohorts

  • Experimental: NVP-1203
    • NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose
  • Active Comparator: NVP-1203-R
    • NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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)
  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NVP Healthcare
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Seong-Hwan Moon, MD, Principal Investigator, Severance Hospital
    • Jin Hwan Kim, MD, Principal Investigator, Inje University
    • Tae Kyun Kim, MD, Principal Investigator, Wonkwang University Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.