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

Acute Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341832
• Other study ID #: NVP-1203_P2
• Status: Completed
• Phase: Phase 2
• Start date: January 31, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: February 2018
• 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- and placebo-controlled, parallel, phase II study to evaluate efficacy and safety of NVP-1203 in patients with Acute low back pain

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• 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

• 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

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	VAS Pain Intensity	Improvement in VAS compared to baseline	3, 7 days
Secondary	Finger to Floor Distance (FFD)	Improvement in FFD compared to baseline	3, 7 days
Secondary	Oswestry Disability Index(ODI)	Improvement in ODI compared to baseline	3, 7 days
Secondary	Investigator Global Assessment of Response to Therapy(IGART)	Improvement in IGART compared to baseline	7 days