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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082975
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Navipharm Corporation

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

Condition or disease Intervention/treatment Phase
Acute Low Back Pain Drug: NVP-1203 Drug: NVP-1203-R Drug: NVP-1203 placebo Drug: NVP-1203-R placebo Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 28, 2019
Estimated Primary Completion Date : July 24, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: NVP-1203
NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose
Drug: NVP-1203
Oral dose for 7 days

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

Active Comparator: NVP-1203-R
NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose
Drug: NVP-1203-R
Oral dose for 7 days

Drug: NVP-1203 placebo
Oral dose for 7 days




Primary Outcome Measures :
  1. Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS) [ Time Frame: Baseline and Day 7 ]
    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.


Secondary Outcome Measures :
  1. Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS) [ Time Frame: Baseline and Day 3 ]
    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.

  2. Change from baseline in Finger to Floor Distance(FFD) [ Time Frame: Baseline, Day 3 and Day 7 ]
    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.

  3. Change from baseline in Oswestry Disability Index(ODI) [ Time Frame: Baseline, Day 3 and Day 7 ]
    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)

  4. Change from baseline in Physician's Global Assessment of Response to Therapy(PGART) [ Time Frame: Baseline and Day 7 ]
    Physician's response of change after administration is assessed on 5-point rating scales(very poor, poor, no change, good and very good).



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082975


Contacts
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Contact: Sung Hye Kim +82-31-547-9756 shkim@navipharm.co.kr
Contact: Hyun Ju Choi +82-31-292-5436 hjchoi@navipharm.co.kr

Locations
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Korea, Republic of
Navipharm Recruiting
Suwon-si, Gyeonggi-do, Korea, Republic of, 16209
Contact    82 31 547 9756    shkim@navipharm.co.kr   
Sponsors and Collaborators
Navipharm Corporation
Investigators
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Principal Investigator: Seong-Hwan Moon, MD Severance Hospital
Principal Investigator: Jin Hwan Kim, MD Inje University
Principal Investigator: Tae Kyun Kim, MD Wonkwang University Hospital
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Responsible Party: Navipharm Corporation
ClinicalTrials.gov Identifier: NCT04082975    
Other Study ID Numbers: NVP-1203_P3
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms