Low Back PainPhase 2NCT01806818
Comparing Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients
A Phase 2 study of Low Back Pain, run by Hanmi Pharmaceutical Company Limited at 5 sites in South Korea.
Trial summary
Multi-center Study to Compare Efficacy and Safety between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients during 7 days. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Low Back Pain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Feb 2013to Jul 2013
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing
- 20≤ age ≤60
- A patient has symptom of acute low back pain
- 4≤ VAS
Who cannot join
- Subjects who cannot prohibit anti-inflammatory drug, painkiller or muscle relaxants during clinical trial
- Chronic rheumatoid arthritis patients
- Patients having a medical history of hypersensitivity to Eperisone Hydrochloride
- Subject having a hereditary problem such as galactose intolerance, Lapp lactase deficiency, or glucose galatose malabsorption
- Participation in other studies before 60 days of first dosing
- Female patients having positive pregnancy test, lactating women,planning pregnancy during clinical trial
- Inadequate subject for the clinical trial by the investigator's decision
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Hallym University Sacred Heart Hospital
Anyang
CHA Bundang Medical Center
Seoul
Kyung Hee University Hospital
Seoul
Medical college of Yonsei University, Gangnam Severance Hospital
Seoul
Severance Hospital
Seoul
About this study
Official title: A Phase 2, Randomized, Double-blind, Parallel, Placebo-controlled, Multi-center Study to Compare Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients
Multi-center Study to Compare Efficacy and Safety between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients during 7 days.
- Conditions
- Low Back Pain
- Being tested
- Epirisone 50mg or placebo TID
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epirisone 50mg or placebo TIDDrug
3 times a day after meals for 1 week
| Study group | Role | What they receive |
|---|---|---|
| Eperisone 50mg BID | Experimental | Administrate Eperisone 50mg tablet after the breakfast and dinner, and pacebo tablet after the lunch for 7 days Receives: Drug: Epirisone 50mg or placebo TID |
| Epirisone 50mg TID | Experimental | Not described Receives: Drug: Epirisone 50mg or placebo TID |
| Placebo comparator | Placebo comparator | Not described Receives: Drug: Epirisone 50mg or placebo TID |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS improvement of pain at rest, on movement and at night
Measured: 7 days
Secondary outcomes (5)
Change of Modified Schober test
Measured: 7 days
Change of Lateral Body Bending test
Measured: 7 days
Change of EuroQol by patients
Measured: 7 days
Change of Oswestry Disability Index
Measured: 7 days
Overall pain improvement by investigator
Measured: at last visit (D7+2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hak-Sun Kim, M.D., Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806818
- Sponsor's protocol ID
- HM-EPAC-201
- Status last verified
- Aug 2013
- First submitted
- 6 Mar 2013
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Parallel, Placebo-controlled, Multi-center Study to Compare Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT01806818
- Acronym / sponsor ID
- HM-EPAC-201
- Conditions
- Low Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 Mar 2013 (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.
Multi-center Study to Compare Efficacy and Safety between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients during 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eperisone 50mg BID | Experimental | Drug: Epirisone 50mg or placebo TIDAdministrate Eperisone 50mg tablet after the breakfast and dinner, and pacebo tablet after the lunch for 7 days |
| Epirisone 50mg TID | Experimental | Drug: Epirisone 50mg or placebo TID |
| Placebo comparator | Placebo comparator | Drug: Epirisone 50mg or placebo TID |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing
- 20≤ age ≤60
- A patient has symptom of acute low back pain
- 4≤ VAS
Key exclusion criteria (7 listed)
- Subjects who cannot prohibit anti-inflammatory drug, painkiller or muscle relaxants during clinical trial
- Chronic rheumatoid arthritis patients
- Patients having a medical history of hypersensitivity to Eperisone Hydrochloride
- Subject having a hereditary problem such as galactose intolerance, Lapp lactase deficiency, or glucose galatose malabsorption
- Participation in other studies before 60 days of first dosing
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 |
|---|---|---|
| Epirisone 50mg or placebo TID3 times a day after meals for 1 week | Drug | Eperisone 50mg BID, Epirisone 50mg TID, Placebo comparator |
Primary outcome
VAS improvement of pain at rest, on movement and at night
Time frame: 7 days
5 secondary outcomes
Change of Modified Schober test
Time frame: 7 days
Change of Lateral Body Bending test
Time frame: 7 days
Change of EuroQol by patients
Time frame: 7 days
Change of Oswestry Disability Index
Time frame: 7 days
Overall pain improvement by investigator
Time frame: at last visit (D7+2)
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 23 Aug 2013.
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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.
Hak-Sun Kim, M.D. principal investigator
Gangnam Severance Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Low Back Pain, run by Hanmi Pharmaceutical Company Limited at 5 sites in South Korea.
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 7 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 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
VAS improvement of pain at rest, on movement and at night (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 23 Aug 2013.