Acute Back PainPhase 3NCT02040415
Phase 3 Study to Evaluate the Efficacy and Safety of DW-1030 and Eperisone HCl in Acute Back Pain Patients
A Phase 3 study testing DW-1030(eperisone HCl) 75mg and Myonal Tab.(eperisone HCl) 50mg in people with Acute Back Pain, run by Daewon Pharmaceutical Co., Ltd..
Trial summary
The purpose of this clinical study is to determine whether or not DW-1030 is not inferior to eperisone HCl in efficacy and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Back Pain
- What is being tested?
- DW-1030(eperisone HCl) 75mg and Myonal Tab.(eperisone HCl) 50mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jul 2014
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official 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
The purpose of this clinical study is to determine whether or not DW-1030 is not inferior to eperisone HCl in efficacy and safety.
- Conditions
- Acute Back Pain
- Being tested
- DW-1030(eperisone HCl) 75mg, Myonal Tab.(eperisone HCl) 50mg, Placebo drug of DW-1030, Placebo drug of Myonal Tab.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW-1030(eperisone HCl) 75mgDrug
Myonal Tab.(eperisone HCl) 50mgDrug
Placebo drug of DW-1030Drug
Placebo drug of Myonal Tab.Drug
| Study group | Role | What they receive |
|---|---|---|
| DW-1030(eperisone HCl) | Experimental | DW-1030(eperisone HCl) 75mg BID Receives: Drug: DW-1030(eperisone HCl) 75mg; Drug: Placebo drug of Myonal Tab. |
| Myonal Tab.(eperisone HCl) | Active comparator | Myonal Tab.(eperisone HCl) 50mg TID Receives: Drug: Myonal Tab.(eperisone HCl) 50mg; Drug: Placebo drug of DW-1030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Finger-to-Floor Distance(FFD) compared to baseline 7days after administration
Measured: 1, 3, 7 day
Secondary outcomes (4)
Changes of 100mm Pain VAS
Measured: -3, 1, 3, 7 day
Oswestry Disability Index (ODI)
Measured: 1, 3, 7 day
Physician's Global Assessment
Measured: 7 day
The number of using rescue drugs and the total amount
Measured: 1, 3, 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 242 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
- NCT02040415
- Sponsor's protocol ID
- DW-1030_301
- Status last verified
- Oct 2016
- First submitted
- 17 Jan 2014
- Last updated
- 12 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02040415
- Acronym / sponsor ID
- DW-1030_301
- Conditions
- Acute Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- First posted
- 20 Jan 2014 (estimated)
- 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.
The purpose of this clinical study is to determine whether or not DW-1030 is not inferior to eperisone HCl in efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DW-1030(eperisone HCl) | Experimental | Drug: DW-1030(eperisone HCl) 75mg, Drug: Placebo drug of Myonal Tab.DW-1030(eperisone HCl) 75mg BID |
| Myonal Tab.(eperisone HCl) | Active comparator | Drug: Myonal Tab.(eperisone HCl) 50mg, Drug: Placebo drug of DW-1030Myonal Tab.(eperisone HCl) 50mg TID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| DW-1030(eperisone HCl) 75mg | Drug | DW-1030(eperisone HCl) |
| Myonal Tab.(eperisone HCl) 50mg | Drug | Myonal Tab.(eperisone HCl) |
| Placebo drug of DW-1030 | Drug | Myonal Tab.(eperisone HCl) |
| Placebo drug of Myonal Tab. | Drug | DW-1030(eperisone HCl) |
Primary outcome
Changes of Finger-to-Floor Distance(FFD) compared to baseline 7days after administration
Time frame: 1, 3, 7 day
4 secondary outcomes
Changes of 100mm Pain VAS
Time frame: -3, 1, 3, 7 day
Oswestry Disability Index (ODI)
Time frame: 1, 3, 7 day
Physician's Global Assessment
Time frame: 7 day
The number of using rescue drugs and the total amount
Time frame: 1, 3, 7 days
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 12 Oct 2016.
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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 3 study testing DW-1030(eperisone HCl) 75mg and Myonal Tab.(eperisone HCl) 50mg in people with Acute 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 4 inclusion and 6 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 12 Oct 2016. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Changes of Finger-to-Floor Distance(FFD) compared to baseline 7days after administration (time frame: 1, 3, 7 day). 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 12 Oct 2016.