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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2019-01-15

Brief Summary

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

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Detailed Description

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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

Conditions

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Acute Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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NVP-1203

oral dose for 7 days

Intervention Type DRUG

NVP-1203-R

oral dose for 7 days

Intervention Type DRUG

NVP-1203 placebo

oral dose for 7 days

Intervention Type DRUG

NVP-1203-R placebo

oral dose for 7 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No