A 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 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: Completed
• Conditions: Acute Low Back Pain
• Intervention / Treatment: Drug: Placebo Oral Tablet; Drug: DW340(pelubiprofen/eperisone); Drug: Pelubi(pelubiprofen)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
100mm VAS	The change of 100mm movement pain VAS between basline and end point	7 days

Collaborators and Investigators

• Sponsor: Daewon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2016
• Primary Completion (Actual): August 30, 2016
• Study Completion (Actual): August 30, 2016

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Neuromuscular Agents; Muscle Relaxants, Central; Eperisone
• Other Study ID 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