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

Primary Purpose

Acute Low Back Pain

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NVP-1203
NVP-1203-R
NVP-1203 placebo
NVP-1203-R placebo
Sponsored by
NVP Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Low Back Pain

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Navipharm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NVP-1203

NVP-1203-R

Arm Description

NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose

NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose

Outcomes

Primary Outcome Measures

Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)
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 Outcome Measures

Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)
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)
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)
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)
Physician's response of change after administration is assessed on 5-point rating scales(very poor, poor, no change, good and very good).

Full Information

First Posted
September 4, 2019
Last Updated
June 3, 2021
Sponsor
NVP Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT04082975
Brief Title
Efficacy and Safety of NVP-1203 and NVP-1203-R in Patients With Acute Low Back Pain
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
May 24, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NVP Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
421 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NVP-1203
Arm Type
Experimental
Arm Description
NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose
Arm Title
NVP-1203-R
Arm Type
Active Comparator
Arm Description
NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose
Intervention Type
Drug
Intervention Name(s)
NVP-1203
Intervention Description
Oral dose for 7 days
Intervention Type
Drug
Intervention Name(s)
NVP-1203-R
Intervention Description
Oral dose for 7 days
Intervention Type
Drug
Intervention Name(s)
NVP-1203 placebo
Intervention Description
Oral dose for 7 days
Intervention Type
Drug
Intervention Name(s)
NVP-1203-R placebo
Intervention Description
Oral dose for 7 days
Primary Outcome Measure Information:
Title
Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)
Description
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.
Time Frame
Baseline and Day 7
Secondary Outcome Measure Information:
Title
Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)
Description
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.
Time Frame
Baseline and Day 3
Title
Change from baseline in Finger to Floor Distance(FFD)
Description
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.
Time Frame
Baseline, Day 3 and Day 7
Title
Change from baseline in Oswestry Disability Index(ODI)
Description
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)
Time Frame
Baseline, Day 3 and Day 7
Title
Change from baseline in Physician's Global Assessment of Response to Therapy(PGART)
Description
Physician's response of change after administration is assessed on 5-point rating scales(very poor, poor, no change, good and very good).
Time Frame
Baseline and Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Hwan Moon, MD
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin Hwan Kim, MD
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tae Kyun Kim, MD
Organizational Affiliation
Wonkwang University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Navipharm
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
16209
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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