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Completed

NCT Number: NCT02040415

Phase 3 Study to Evaluate the Efficacy and Safety of DW-1030 and Eperisone HCl in Acute Back Pain Patients

The purpose of this clinical study is to determine whether or not DW-1030 is not inferior to eperisone HCl in efficacy and safety.

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Key information

Conditions

Acute Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult males/Females aged over 18 years
  • Patients with symptom of Acute skeletomuscle myospasm and Back pain
  • Patients with Pain VAS Value over 40 mm in Visit 2
  • Subjects who voluntarily or legal guardian agreed with written consent

Exclusion criteria

  • Patients with Back pain caused by spinal spondylosis, spinal stenosis, fractures, cancer, severe arthritis, osteoporosis, sciatica, infection
  • Muscular patients such as myositis, muscular atrophy disease, increased muscle tone, myasthenia gravis
  • Patients who had taken invasive procedures such as epidural injections or spinal stimulation to cure the back pain within 6 months from the screening point
  • Patients who had taken passive physical therapy or ionphoresis within 12 hours from the screening point
  • Patients with severe GI tract disorder, heart disease, hypertension
  • Patients who had taken NSAIDS within 24hours from the screening point

Treatment and study plan

DW-1030(eperisone HCl) 75mg

Drug

Myonal Tab.(eperisone HCl) 50mg

Drug

Placebo drug of DW-1030

Drug

Placebo drug of Myonal Tab.

Drug

Primary outcomes

  1. Changes of Finger-to-Floor Distance(FFD) compared to baseline 7days after administration

    Time frame: 1, 3, 7 day

Secondary outcomes

  1. Changes of 100mm Pain VAS

    Time frame: -3, 1, 3, 7 day

  2. Oswestry Disability Index (ODI)

    Time frame: 1, 3, 7 day

  3. Physician's Global Assessment

    Time frame: 7 day

  4. The number of using rescue drugs and the total amount

    Time frame: 1, 3, 7 days

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase Lll Clinical Trial to Evaluate the Efficacy and Safety of DW-1030 and Eperisone HCl in Acute Back Pain Patients

Important dates

Study start
2014
Primary completion
2014
First posted
Jan 20, 2014
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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