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

NVP Healthcare

Status and phase: Completed; Phase 3

Conditions: Acute Low Back Pain

Treatments: Drug: NVP-1203-R placebo; Drug: NVP-1203 placebo; Drug: NVP-1203; Drug: NVP-1203-R

Study type: Interventional

Funder types: Industry

Identifiers

NCT04082975

NVP-1203_P3

Details and patient eligibility

About

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

Full 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.

Enrollment: 421 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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421 participants in 2 patient groups

NVP-1203

Experimental group

Description:

NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose

Treatment:

Drug: NVP-1203-R placebo

Drug: NVP-1203

NVP-1203-R

Active Comparator group

Description:

NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose

Treatment:

Drug: NVP-1203 placebo

Drug: NVP-1203-R