Acute Low Back PainNCT01638286
Study to Evaluate a Pharmacokinetic Drug Interaction Between Eperisone Hydrochloride and Aceclofenac in Healthy Male Subjects
An observational study of Acute Low Back Pain, run by Hanmi Pharmaceutical Company Limited.
Trial summary
A randomized, open label, single-dose, 6-sequence, 3-period, crossover study to evaluate a pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Low Back Pain
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Apr 2013
- Phase
- Observational
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Acute low back pain
Who may be able to join
- BMI : 20.0 - 28.0 kg/m2 willingness to sign the written informed consent form(ICF)
Who cannot join
- Evidence of clinically relevant pathology within 30 days prior to drug administration History of relevant drug and/or food allergies
About this study
A randomized, open label, single-dose, 6-sequence, 3-period, crossover study to evaluate a pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy male subjects.
- Conditions
- Acute Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Eperisone | Not described | |
| Aceclofenac | Not described | |
| Eperisone hydrochloride, Aceclofenac | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2012
- Study completionApr 2013
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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638286
- Sponsor's protocol ID
- HM-EPAC-101
- Status last verified
- Mar 2014
- First submitted
- 9 Jul 2012
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate a Pharmacokinetic Drug Interaction Between Eperisone Hydrochloride and Aceclofenac in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01638286
- Acronym / sponsor ID
- HM-EPAC-101
- Conditions
- Acute Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Jul 2012 (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.
A randomized, open label, single-dose, 6-sequence, 3-period, crossover study to evaluate a pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy male subjects.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eperisone | – | – |
| Aceclofenac | – | – |
| Eperisone hydrochloride, Aceclofenac | – | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Acute low back pain
Key inclusion criteria (1 listed)
- BMI : 20.0 - 28.0 kg/m2 willingness to sign the written informed consent form(ICF)
Key exclusion criteria (1 listed)
- Evidence of clinically relevant pathology within 30 days prior to drug administration History of relevant drug and/or food allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 11 Mar 2014.
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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?
An observational study of Acute Low Back Pain, run by Hanmi Pharmaceutical Company Limited.
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 1 inclusion and 1 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 11 Mar 2014. 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.
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.
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 11 Mar 2014.