Back to resultsEfficacy and Safety of NVP-1203 in Patients With Acute Low Back Pain
Primary Purpose
Acute Low Back Pain
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NVP-1203
NVP-1203-R
NVP-1203 placebo
NVP-1203-R placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Low Back Pain
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
- 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
Sites / Locations
- Navipharm
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
NVP-1203
NVP-1203-R
Placebo
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
NVP-1203 placebo plus NVP-1203-R placebo for up to 7 days, oral dose
Outcomes
Primary Outcome Measures
VAS Pain Intensity
Improvement in VAS compared to baseline
Secondary Outcome Measures
Finger to Floor Distance (FFD)
Improvement in FFD compared to baseline
Oswestry Disability Index(ODI)
Improvement in ODI compared to baseline
Investigator Global Assessment of Response to Therapy(IGART)
Improvement in IGART compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03341832
Brief Title
Efficacy and Safety of NVP-1203 in Patients With Acute Low Back Pain
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
January 15, 2019 (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- and placebo-controlled, parallel, phase II 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
NVP-1203 placebo plus NVP-1203-R 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
VAS Pain Intensity
Description
Improvement in VAS compared to baseline
Time Frame
3, 7 days
Secondary Outcome Measure Information:
Title
Finger to Floor Distance (FFD)
Description
Improvement in FFD compared to baseline
Time Frame
3, 7 days
Title
Oswestry Disability Index(ODI)
Description
Improvement in ODI compared to baseline
Time Frame
3, 7 days
Title
Investigator Global Assessment of Response to Therapy(IGART)
Description
Improvement in IGART compared to baseline
Time Frame
7 days
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
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
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 in Patients With Acute Low Back Pain
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