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

June 3, 2021 updated by: NVP Healthcare

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

421

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16209
        • Navipharm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NVP-1203
NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose
Drug: NVP-1203
Oral dose for 7 days
Drug: NVP-1203-R placebo
Oral dose for 7 days
Active Comparator: NVP-1203-R
NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose
Drug: NVP-1203-R
Oral dose for 7 days
Drug: NVP-1203 placebo
Oral dose for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 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.
Baseline, Day 3 and Day 7
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)
Baseline, Day 3 and Day 7
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).
Baseline and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NVP Healthcare

Investigators

  • Principal Investigator: Seong-Hwan Moon, MD, Severance Hospital
  • Principal Investigator: Jin Hwan Kim, MD, Inje University
  • Principal Investigator: Tae Kyun Kim, MD, Wonkwang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Actual)

May 24, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVP-1203_P3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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