NCT03341832

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

September 18, 2019

Status Verified

February 1, 2018

Enrollment Period

12 months

First QC Date

November 9, 2017

Last Update Submit

September 16, 2019

Conditions

Acute Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • VAS Pain Intensity

    Improvement in VAS compared to baseline

    3, 7 days

Secondary Outcomes (3)

  • Finger to Floor Distance (FFD)

    3, 7 days

  • Oswestry Disability Index(ODI)

    3, 7 days

  • Investigator Global Assessment of Response to Therapy(IGART)

    7 days

Study Arms (3)

NVP-1203

EXPERIMENTAL

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

Drug: NVP-1203Drug: NVP-1203-R placebo

NVP-1203-R

ACTIVE COMPARATOR

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

Drug: NVP-1203-RDrug: NVP-1203 placebo

Placebo

PLACEBO COMPARATOR

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

Drug: NVP-1203 placeboDrug: NVP-1203-R placebo

Interventions

NVP-1203DRUG

oral dose for 7 days

NVP-1203
NVP-1203-RDRUG

oral dose for 7 days

NVP-1203-R
NVP-1203 placeboDRUG

oral dose for 7 days

NVP-1203-RPlacebo
NVP-1203-R placeboDRUG

oral dose for 7 days

NVP-1203Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Years and older
  • A patient has symptom of acute low back pain

You may not qualify if:

  • Subjects who cannot prohibit anti-inflammatory drug or muscle relaxants during clinical trial
  • Inadequate subject for the clinical trial by the investigator's decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navipharm

Suwon, Gyeonggi-do, 16209, South Korea

Location

Study Officials

  • Seong-Hwan Moon, MD

    Severance Hospital

    PRINCIPAL INVESTIGATOR

  • Jin Hwan Kim, MD

    Inje University

    PRINCIPAL INVESTIGATOR

  • Tae Kyun Kim, MD

    Wonkwang University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 14, 2017

Study Start

January 31, 2018

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

September 18, 2019

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)