Acute Upper Respiratory InfectionPhase 3NCT01779271
Phase 3 Study of Pelubiprofen & Loxoprofen in Patients With Upper Respiratory Tract Infection
A Phase 3 study testing Pelubiprofen and Loxoprofen in people with Acute Upper Respiratory Infection and Fever, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
Multi-center, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3 Clinical trial to assess the efficacy and safety of Pelubiprofen Compared to Loxoprofen in patients with Acute upper respiratory infection. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Upper Respiratory Infection, Fever
- What is being tested?
- Pelubiprofen and Loxoprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Mar 2016
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Over 15 years old
- Male and Female
- Patients with fever over 38.0°C due to cold (acute upper respiratory tract infection)
- Patients with upper respiratory tract infection outbreak within 2 days and who did not received drug administration
- Subjects who voluntarily or legal guardian agreed with written consent
Who cannot join
- Fever reducer administration Within 4 hours from the screening point
- Any incidence of febrile crisis from the past six months
- Patients with Ulcers, gastrointestinal disorders which are confirmed by endoscopy
- Patients with continuously administrating gastrointestinal disorder related drug
- Patients with severe blood damage
- Severe hepatic impairment (ALT, AST value more than 2 times the upper limit of the normal range)
- With severe renal impairment (serum creatinine value is more than 2 times the upper limit of the normal range)
- Patients with severe left ventricular dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Multi-center, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3 Clinical trial to assess the efficacy and safety of Pelubiprofen Compared to Loxoprofen in patients with Acute upper respiratory infection.
- Conditions
- Acute Upper Respiratory Infection, Fever
- Being tested
- Pelubiprofen, Loxoprofen
- Keywords
- Pelubi, Pelubiprofen, Loxoprofen, Anti-pyretic, Fever
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PelubiprofenDrug
Also called Pelubiprofen 30 mg
LoxoprofenDrug
Also called Loxoprofen 60mg
| Study group | Role | What they receive |
|---|---|---|
| Pelubiprofen | Experimental | Not described Receives: Drug: Pelubiprofen |
| Loxoprofen | Active comparator | Not described Receives: Drug: Loxoprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Body temperature from baseline
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Upper Respiratory InfectionStudies 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
- 183 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
- NCT01779271
- Sponsor's protocol ID
- Plb CD 301 Version 3.10
- Status last verified
- Oct 2016
- First submitted
- 21 Jan 2013
- Last updated
- 10 Oct 2016
- Results posted
- No
Publications
Jang AS, Kim SH, Lee SP, Na MJ, Yoo KH, Park CH, Park SY, Choi BW. The Efficacy and Safety of Pelubiprofen in the Treatment of Acute Upper Respiratory Tract Infection: A Multicenter, Randomized, Double-Blind, Non-Inferiority Phase III Clinical Trial Compared to Loxoprofen. J Clin Med. 2025 Feb 21;14(5):1450. doi: 10.3390/jcm14051450.
PubMed 40094866
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 Pelubiprofen & Loxoprofen in Patients With Upper Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT01779271
- Acronym / sponsor ID
- Plb CD 301 Version 3.10
- Conditions
- Acute Upper Respiratory Infection, Fever
- Keywords
- Pelubi, Pelubiprofen, Loxoprofen, Anti-pyretic, Fever
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Mar 2016 (actual)
- First posted
- 30 Jan 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, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3 Clinical trial to assess the efficacy and safety of Pelubiprofen Compared to Loxoprofen in patients with Acute upper respiratory infection.
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 |
| Loxoprofen | Active comparator | Drug: Loxoprofen |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Over 15 years old
- Male and Female
- Patients with fever over 38.0°C due to cold (acute upper respiratory tract infection)
- Patients with upper respiratory tract infection outbreak within 2 days and who did not received drug administration
- Subjects who voluntarily or legal guardian agreed with written consent
Key exclusion criteria (8 listed)
- Fever reducer administration Within 4 hours from the screening point
- Any incidence of febrile crisis from the past six months
- Patients with Ulcers, gastrointestinal disorders which are confirmed by endoscopy
- Patients with continuously administrating gastrointestinal disorder related drug
- Patients with severe blood damage
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 |
|---|---|---|
| PelubiprofenAlso: Pelubiprofen 30 mg | Drug | Pelubiprofen |
| LoxoprofenAlso: Loxoprofen 60mg | Drug | Loxoprofen |
Primary outcome
Changes in Body temperature from baseline
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour
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.
- Derived from this study: PubMed 40094866Jang AS, Kim SH, Lee SP, Na MJ, Yoo KH, Park CH, Park SY, Choi BW. The Efficacy and Safety of Pelubiprofen in the Treatment of Acute Upper Respiratory Tract Infection: A Multicenter, Randomized, Double-Blind, Non-Inferiority Phase III Clinical Trial Compared to Loxoprofen. J Clin Med. 2025 Feb 21;14(5):1450. doi: 10.3390/jcm14051450.
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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.
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 and Loxoprofen in people with Acute Upper Respiratory Infection and Fever, 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 5 inclusion and 8 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.
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. 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 in Body temperature from baseline (time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01779271, which also lists 1 linked publication.
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.