Acute Low Back PainPhase 2NCT03424707
A Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of DW340 in Patients With Acute Low Back Pain
A Phase 2 study testing DW340(pelubiprofen/eperisone) and Pelubi(pelubiprofen) in people with Acute Low Back Pain, run by Daewon Pharmaceutical Co., Ltd..
Trial summary
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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Low Back Pain
- What is being tested?
- DW340(pelubiprofen/eperisone) and Pelubi(pelubiprofen)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2016to 30 Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 19 years of age
- 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)
- Participation and voluntary agreement
Who cannot join
- Drugs for Clinical Trial or Similar Drugs and Components with Hypersensitivity or Aspirin or Nonsteroidal Anti-inflammatory Drugs
- 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)
- 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
- 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)
- 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)
- 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
- Those who are unable to participate in the clinical trial according to the testee's judgment
About this study
Official title: 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
- Conditions
- Acute Low Back Pain
- Being tested
- DW340(pelubiprofen/eperisone), Pelubi(pelubiprofen), Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW340(pelubiprofen/eperisone)Drug
DW340
Pelubi(pelubiprofen)Drug
pelubiprofen
Placebo Oral TabletDrug
Placebo Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| combination | Experimental | Not described Receives: Drug: DW340(pelubiprofen/eperisone) |
| single | Active comparator | Not described Receives: Drug: Pelubi(pelubiprofen) |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
100mm VAS
The change of 100mm movement pain VAS between basline and end point
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start4 Mar 2016
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424707
- Sponsor's protocol ID
- DW340-P2
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2018
- Last updated
- 7 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03424707
- Acronym / sponsor ID
- DW340-P2
- Conditions
- Acute Low Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| combination | Experimental | Drug: DW340(pelubiprofen/eperisone) |
| single | Active comparator | Drug: Pelubi(pelubiprofen) |
| placebo | Placebo comparator | Drug: Placebo Oral Tablet |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over 19 years of age
- 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)
- Participation and voluntary agreement
Key exclusion criteria (8 listed)
- Drugs for Clinical Trial or Similar Drugs and Components with Hypersensitivity or Aspirin or Nonsteroidal Anti-inflammatory Drugs
- 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)
- 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
- 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)
- Pregnant or lactating women and appropriate contraceptive *
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DW340(pelubiprofen/eperisone)DW340 | Drug | combination |
| Pelubi(pelubiprofen)pelubiprofen | Drug | single |
| Placebo Oral TabletPlacebo Oral Tablet | Drug | placebo |
Primary outcome
100mm VAS
Time frame: 7 days
The change of 100mm movement pain VAS between basline and end point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DW340(pelubiprofen/eperisone) and Pelubi(pelubiprofen) in people with Acute Low Back Pain, run by Daewon Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100mm VAS (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.