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

September 16, 2019 updated by: NVP Healthcare

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

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- and placebo-controlled, parallel, phase II study to evaluate efficacy and safety of NVP-1203 in patients with Acute low back pain

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 2

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

17 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
  • 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

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
Placebo Comparator: Placebo
NVP-1203 placebo plus NVP-1203-R placebo for up to 7 days, oral dose
Drug: NVP-1203-R placebo
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
VAS Pain Intensity
Time Frame: 3, 7 days
Improvement in VAS compared to baseline
3, 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Finger to Floor Distance (FFD)
Time Frame: 3, 7 days
Improvement in FFD compared to baseline
3, 7 days
Oswestry Disability Index(ODI)
Time Frame: 3, 7 days
Improvement in ODI compared to baseline
3, 7 days
Investigator Global Assessment of Response to Therapy(IGART)
Time Frame: 7 days
Improvement in IGART compared to baseline
7 days

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 31, 2018

Primary Completion (Actual)

January 15, 2019

Study Completion (Actual)

January 15, 2019

Study Registration Dates

First Submitted

November 9, 2017

First Submitted That Met QC Criteria

November 9, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVP-1203_P2

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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