A Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of DW340 in Patients With Acute Low Back Pain

February 5, 2018 updated by: Daewon Pharmaceutical Co., Ltd.

A Single-Center, Randomized, Double-Blind, Parallel, Pilot Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of DW340 in Patients With Acute Low Back Pain

A Single-Center, Randomized, Double-Blind, Parallel, Pilot Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Pelubiprofen/Eperisone in Patients with Acute Low Back Pain

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults over 19 years of age
  2. Patients with a paraxial (muscle spasm) of less than 21 days and acute lower back pain. Randomized intervention. Arterial pain 100 mm - visual analogue scale (VAS)
  3. Participation and voluntary agreement

Exclusion Criteria:

  1. Drugs for Clinical Trial or Similar Drugs and Components with Hypersensitivity or Aspirin or Nonsteroidal Anti-inflammatory Drugs
  2. Those accompanying the following diseases (1) patients with severe underlying diseases that cause back pain (eg, cancer, spinal infections, cauda equina syndrome, spinal stenosis, neuropathy, vertebral compression fracture, posterior hiatal joint syndrome, intervertebral disc herniation, fibromyalgia, Spondylolisthesis, imaging confirmed degenerative spondylosis, severe arthritis or severe osteoporosis) (2) myositis, muscular atrophy, myotonia, myasthenia (3) peptic ulcer or duodenal ulcer (4) Gastrointestinal bleeding or bleeding disorder (5) severe heart failure (NYHA class III / IV) (6) Uncontrolled hypertension (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg) (7) Liver impairment (AST or ALT ≥ 3 × upper normal level of the organ) or renal impairment (CLcr <30 mL / min)
  3. Those who have confirmed the following history or surgery / (1) lumbar surgery (2) Unstable angina pectoris, myocardial infarction, transient ischemic attack, stroke, coronary artery bypass surgery or coronary artery bypass graft within 6 months from screening (3) galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, (4) malignant tumor within 5 years from the screening point
  4. Drugs that may affect the following efficacy evaluations during clinical trials, or those expected to require drug interactions with the clinical trial drug (provided there is a separate standard, such as a nonsteroidal anti-inflammatory drug) Follow the standard.) (1) Nonsteroidal antiinflammatory drugs: pelubiprofen, aceclofenac, diclofenac, ketorolac (from 1 week before randomization until the end of the clinical trial, except oxaprozin and oxicam 2 weeks before randomization) (2) Muscle relaxants: eperisone, baclofen, cyclobenzaprine, dantrolene, thiocolchicoside, tizanidine (from 1 week before randomization until the end of the study) (3) Analgesics: acetaminophen (paracetamol), codeine, oxycodone, tramadol, etc. (However, in the case of narcotic analgesics, (4) systemic or low back pain or steroids (from 4 weeks prior to randomization until the end of the study) (5) Contraindications during other clinical trials Drug / taboo treatment (see 7.4)

  5. Pregnant or lactating women and appropriate contraceptive *

    * Use of hormonal contraceptive, intrauterine devices, spouse sterilization (vasectomy, tubal ligation, etc.), double blockage (use of spermicide in combination with vaginal septum, vaginal sponge or neck cap)

  6. Those who have received other clinical trial drugs within a longer period of 12 weeks or more than half of the half-life before screening
  7. Those who are unable to participate in the clinical trial according to the testee's judgment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: placebo
Drug: Placebo Oral Tablet
Placebo Oral Tablet
Experimental: combination
Drug: DW340(pelubiprofen/eperisone)
DW340
Active Comparator: single
Drug: Pelubi(pelubiprofen)
pelubiprofen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
100mm VAS
Time Frame: 7 days
The change of 100mm movement pain VAS between basline and end point
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DW340-P2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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