Acute Traumatic InjuryPhase 3NCT03874247
Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury
A Phase 3 study testing pelubiprofen 45mg in people with Acute Traumatic Injury, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A randomized, double-blind, placebo-controlled, parallel, multi-center phase III clinical trial Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Traumatic Injury
- What is being tested?
- pelubiprofen 45mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Feb 2019to 31 Dec 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient, ages over 19 years
- Patients with post traumatic acute pain within 48 hr(sprain/strain)
- Patient whose pain scale is over 50 mm(VAS score)
Who cannot join
- Patients with chronic pain
- Presence of a fracture or more than one injury
- Previous adverse reaction or known allergy to NSAIDs
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, Seodaemun-gu
LEE, Ph.D.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury
A randomized, double-blind, placebo-controlled, parallel, multi-center phase III clinical trial
- Conditions
- Acute Traumatic Injury
- Being tested
- pelubiprofen 45mg, pelubiprofen placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelubiprofen 45mgDrug
bid for 3 days after meal
pelubiprofen placeboDrug
bid for 3 days after meal
| Study group | Role | What they receive |
|---|---|---|
| Pelubiprofen | Experimental | Not described Receives: Drug: pelubiprofen 45mg |
| Pelubiprofen placebo | Placebo comparator | Not described Receives: Drug: pelubiprofen placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID-D3
Sum of Pain Intensity Differences(100 mm pain VAS)
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start25 Feb 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Traumatic InjuryStudies 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
- 94 participants (estimated)
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
- NCT03874247
- Sponsor's protocol ID
- DW9801-302
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 19 Mar 2019
- 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 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of 'Pelubiprofen Controlled Released Tab.' in Acute Traumatic Injury
- ClinicalTrials.gov ID
- NCT03874247
- Acronym / sponsor ID
- DW9801-302
- Conditions
- Acute Traumatic Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 14 Mar 2019 (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 randomized, double-blind, placebo-controlled, parallel, multi-center phase III clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelubiprofen | Experimental | Drug: pelubiprofen 45mg |
| Pelubiprofen placebo | Placebo comparator | Drug: pelubiprofen placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient, ages over 19 years
- Patients with post traumatic acute pain within 48 hr(sprain/strain)
- Patient whose pain scale is over 50 mm(VAS score)
Key exclusion criteria (3 listed)
- Patients with chronic pain
- Presence of a fracture or more than one injury
- Previous adverse reaction or known allergy to NSAIDs
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 |
|---|---|---|
| pelubiprofen 45mgbid for 3 days after meal | Drug | Pelubiprofen |
| pelubiprofen placebobid for 3 days after meal | Drug | Pelubiprofen placebo |
Primary outcome
SPID-D3
Time frame: Day 3
Sum of Pain Intensity Differences(100 mm pain VAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
Related trials for Acute Traumatic Injury
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pelubiprofen 45mg in people with Acute Traumatic Injury, run by Daewon Pharmaceutical Co., Ltd. at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MOON (+82-2-2204-7094, moonyw@daewonpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPID-D3 (time frame: Day 3). 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 19 Mar 2019.