Efficacy and Safety of NVP-1203 and NVP-1203-R in Patients With Acute Low Back Pain
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
1 other identifier
interventional
421
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety NVP-1203 in patients with acute low back pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedStudy Start
First participant enrolled
January 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedJune 7, 2021
June 1, 2021
1.4 years
September 4, 2019
June 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline and Day 7
Secondary Outcomes (4)
Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)
Baseline and Day 3
Change from baseline in Finger to Floor Distance(FFD)
Baseline, Day 3 and Day 7
Change from baseline in Oswestry Disability Index(ODI)
Baseline, Day 3 and Day 7
Change from baseline in Physician's Global Assessment of Response to Therapy(PGART)
Baseline and Day 7
Study Arms (2)
NVP-1203
EXPERIMENTALNVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose
NVP-1203-R
ACTIVE COMPARATORNVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects who cannot prohibit anti-inflammatory drug or muscle relaxants during clinical trial
- Inadequate subject for the clinical trial by the investigator's decision
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NVP Healthcarelead
Study Sites (1)
Navipharm
Suwon, Gyeonggi-do, 16209, South Korea
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2019
First Posted
September 10, 2019
Study Start
January 15, 2020
Primary Completion
May 24, 2021
Study Completion
May 31, 2021
Last Updated
June 7, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share