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

Acute Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04082975
• Other study ID #: NVP-1203_P3
• Status: Completed
• Phase: Phase 3
• Start date: January 15, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2021
• Source: Navipharm Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: May 31, 2021
• Est. primary completion date: May 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Low Back Pain
• Back Pain
• Low Back Pain

Intervention

Drug:
• NVP-1203
Oral dose for 7 days
• NVP-1203-R
Oral dose for 7 days
• NVP-1203 placebo
Oral dose for 7 days
• NVP-1203-R placebo
Oral dose for 7 days

Locations

Country	Name	City	State
Korea, Republic of	Navipharm	Suwon-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Navipharm Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and Day 3
Secondary	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.	Baseline, Day 3 and Day 7
Secondary	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)	Baseline, Day 3 and Day 7
Secondary	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).	Baseline and Day 7