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

Phase 3

Completed

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

• Registration Number: NCT04082975
• 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-controlled, parallel, phase 3 study to evaluate efficacy and safety of NVP-1203 in patients with acute low back pain.

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-10
• Study Start: 2020-01-15
• Primary Completion: 2021-05-24
• Study Completion: 2021-05-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 421

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NVP-1203-R	NVP-1203-R	NVP-1203-R plus NVP-1203 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-R	NVP-1203 placebo	NVP-1203-R plus NVP-1203 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

Primary Outcome Measures

Name	Time	Method
Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)	Baseline and Day 7	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

Name	Time	Method
Change from baseline in Oswestry Disability Index(ODI)	Baseline, Day 3 and Day 7	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 pain intensity assessed by Visual Analogue Scale(VAS)	Baseline and Day 3	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)	Baseline, Day 3 and Day 7	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 Physician's Global Assessment of Response to Therapy(PGART)	Baseline and Day 7	Physician's response of change after administration is assessed on 5-point rating scales(very poor, poor, no change, good and very good).

Trial Locations

Locations (1)

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