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

Phase 2

Completed

• Conditions: Acute Low Back Pain
• Interventions: Drug: NVP-1203; Drug: NVP-1203-R; Drug: NVP-1203-R placebo; Drug: NVP-1203 placebo

• Registration Number: NCT03341832
• Lead Sponsor: NVP Healthcare

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

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-14
• Study Start: 2018-01-31
• Status Verified: 2018-02
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-15
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	NVP-1203-R placebo	NVP-1203 placebo plus NVP-1203-R placebo for up to 7 days, oral dose
NVP-1203	NVP-1203	NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose
NVP-1203	NVP-1203-R placebo	NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose
NVP-1203-R	NVP-1203-R	NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose
NVP-1203-R	NVP-1203 placebo	NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose
Placebo	NVP-1203 placebo	NVP-1203 placebo plus NVP-1203-R placebo for up to 7 days, oral dose

Primary Outcome Measures

Name	Time	Method
VAS Pain Intensity	3, 7 days	Improvement in VAS compared to baseline

Secondary Outcome Measures

Name	Time	Method
Finger to Floor Distance (FFD)	3, 7 days	Improvement in FFD compared to baseline
Oswestry Disability Index(ODI)	3, 7 days	Improvement in ODI compared to baseline
Investigator Global Assessment of Response to Therapy(IGART)	7 days	Improvement in IGART compared to baseline

Trial Locations

Locations (1)

Navipharm; 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of