Chronic Back PainPhase 3NCT02375633
Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients
A Phase 3 study testing DW-330SR2 and Pelubiprofen in people with Chronic Back Pain, run by Daewon Pharmaceutical Co., Ltd..
Trial summary
A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Back Pain
- What is being tested?
- DW-330SR2 and Pelubiprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Nov 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
- More than 12 weeks by the time the trial started , and low back pain that requires analgesia administration.
- Class 1 or 2 back pain patients along Quebec Task Force Classification
- Patients with pain at least 40mm test results at visit2
- The voluntary or legal guardian 's written consent to participate in this clinical trial subjects
Who cannot join
- Severe gastrointestinal disease, heart disease, high blood pressure patients
- Patients with secondary causes are obvious
- Within 24 weeks patient who has back surgery before clinical trial participation
- Within 4 weeks patient who experienced psychotropic drugs, a narcotic analgesic dosage that may affect the pain sensation
- Within 4 weeks patient who treated steroid drug by oral or injection
- Within 2 weeks patient who treated MAO inhibition drugs
- Patients with severe respiratory depression status
About this study
A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients.
- Conditions
- Chronic Back Pain
- Being tested
- DW-330SR2, Pelubiprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW-330SR2Drug
PelubiprofenDrug
| Study group | Role | What they receive |
|---|---|---|
| DW-330SR2 | Experimental | DW-330SR(Pelubiprofen) 45mg twice a day Receives: Drug: DW-330SR2 |
| Pelubiprofen | Active comparator | Active Comparator(Pelubiprofen) 30mg three times a day Receives: Drug: Pelubiprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of 100 mm Pain VAS
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startApr 2014
- Primary completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 166 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
- NCT02375633
- Sponsor's protocol ID
- DW-330SR2_301
- Status last verified
- Oct 2016
- First submitted
- 24 Feb 2015
- Last updated
- 10 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients
- ClinicalTrials.gov ID
- NCT02375633
- Acronym / sponsor ID
- DW-330SR2_301
- Conditions
- Chronic Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- First posted
- 2 Mar 2015 (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 Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DW-330SR2 | Experimental | Drug: DW-330SR2DW-330SR(Pelubiprofen) 45mg twice a day |
| Pelubiprofen | Active comparator | Drug: PelubiprofenActive Comparator(Pelubiprofen) 30mg three times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- More than 12 weeks by the time the trial started , and low back pain that requires analgesia administration.
- Class 1 or 2 back pain patients along Quebec Task Force Classification
- Patients with pain at least 40mm test results at visit2
- The voluntary or legal guardian 's written consent to participate in this clinical trial subjects
Key exclusion criteria (7 listed)
- Severe gastrointestinal disease, heart disease, high blood pressure patients
- Patients with secondary causes are obvious
- Within 24 weeks patient who has back surgery before clinical trial participation
- Within 4 weeks patient who experienced psychotropic drugs, a narcotic analgesic dosage that may affect the pain sensation
- Within 4 weeks patient who treated steroid drug by oral or injection
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-330SR2 | Drug | DW-330SR2 |
| Pelubiprofen | Drug | Pelubiprofen |
Primary outcome
The change of 100 mm Pain VAS
Time frame: 28 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 10 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-330SR2 and Pelubiprofen in people with Chronic 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 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 10 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?
The change of 100 mm Pain VAS (time frame: 28 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 10 Oct 2016.