FeverPhase 3NCT00812422
The Efficacy and Safety of Dexibuprofen Syrup
A Phase 3 study testing Dexibuprofen and Ibuprofen in people with Fever and Respiratory Tract Infection, run by Inje University at 4 sites in South Korea.
Trial summary
The purpose of this study is to compare the safety and efficacy of dexibuprofen syrup and ibuprofen syrup in patients with fever due to common cold. Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- Fever, Respiratory Tract Infection
- What is being tested?
- Dexibuprofen and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Feb 2008to May 2009
- 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 6 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Common cold with fever
- Age 6 months to 14 years
Who cannot join
- Gastric ulcer
- Bleeding tendency
- Liver disease
- Kidney disease
- Hypertension
- Hypersensitivity to the drug
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Asan Medical Center
Seoul
Inje University Sanggye Paik Hospital
Seoul
Korea University Hospital
Seoul
Kyung Hee University Hospital
Seoul
About this study
Official title: Multi-center, Randomized, Double Blinded (Double-dummy), Active-Controlled Parallel-group Comparative, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Dexibuprofen Syrup Compared to Ibuprofen Syrup in Patients With Fever of Common Cold (Acute Upper Respiratory Infection)
The purpose of this study is to compare the safety and efficacy of dexibuprofen syrup and ibuprofen syrup in patients with fever due to common cold.
- Conditions
- Fever, Respiratory Tract Infection
- Being tested
- Dexibuprofen, Ibuprofen
- Keywords
- Fever due to acute upper respiratory tract infection
- Medical subject headings
- Fever, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexibuprofenDrug
one dose of Dexibuprofen 2.5 or 5 mg/kg
DexibuprofenDrug
one dose of Dexibuprofen 3.5 or 7 mg/kg
IbuprofenDrug
one dose of Ibuprofen 5 or 10 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Dexibuprofen 1 | Experimental | Dexibuprofen 2.5 or 5 mg/kg Receives: Drug: Dexibuprofen |
| Dexibuprofen 2 | Experimental | Dexibuprofen 3.5 or 7 mg/kg Receives: Drug: Dexibuprofen |
| Ibuprofen | Active comparator | Ibuprofen 5 or 10 mg/kg Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure reduction in fever
Measured: measure temperature every hour for 3 hours then once again 3 days later
Secondary outcomes (1)
determine safety of dexibuprofen by unwanted reaction, clinical laboratory test and physical examination.
Measured: every hour for 3 hours (unwanted reaction). 3 days later (clinical laboratory test and physical examination).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies 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
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Investigators
- Young Yull Koh, Study director, Seoul National University HospitalChang-Keun Kim, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812422
- Sponsor's protocol ID
- AG_DIBU_2007
- Status last verified
- Jan 2010
- First submitted
- 19 Dec 2008
- Last updated
- 18 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double Blinded (Double-dummy), Active-Controlled Parallel-group Comparative, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Dexibuprofen Syrup Compared to Ibuprofen Syrup in Patients With Fever of Common Cold (Acute Upper Respiratory Infection)
- ClinicalTrials.gov ID
- NCT00812422
- Acronym / sponsor ID
- AG_DIBU_2007
- Conditions
- Fever, Respiratory Tract Infection
- Keywords
- Fever due to acute upper respiratory tract infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Dec 2008 (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.
The purpose of this study is to compare the safety and efficacy of dexibuprofen syrup and ibuprofen syrup in patients with fever due to common cold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexibuprofen 1 | Experimental | Drug: DexibuprofenDexibuprofen 2.5 or 5 mg/kg |
| Dexibuprofen 2 | Experimental | Drug: DexibuprofenDexibuprofen 3.5 or 7 mg/kg |
| Ibuprofen | Active comparator | Drug: IbuprofenIbuprofen 5 or 10 mg/kg |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Common cold with fever
- Age 6 months to 14 years
Key exclusion criteria (6 listed)
- Gastric ulcer
- Bleeding tendency
- Liver disease
- Kidney disease
- Hypertension
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 |
|---|---|---|
| Dexibuprofenone dose of Dexibuprofen 2.5 or 5 mg/kg | Drug | Dexibuprofen 1 |
| Dexibuprofenone dose of Dexibuprofen 3.5 or 7 mg/kg | Drug | Dexibuprofen 2 |
| Ibuprofenone dose of Ibuprofen 5 or 10 mg/kg | Drug | Ibuprofen |
Primary outcome
measure reduction in fever
Time frame: measure temperature every hour for 3 hours then once again 3 days later
1 secondary outcome
determine safety of dexibuprofen by unwanted reaction, clinical laboratory test and physical examination.
Time frame: every hour for 3 hours (unwanted reaction). 3 days later (clinical laboratory test and physical examination).
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 18 Jan 2010.
Related trials for Fever
Recruiting
Assessment of Communication Interventions on Vaccination Knowledge and Acceptance
Vaccination Knowledge and Acceptance, Informed Vaccine-decision Making
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
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.
Young Yull Koh study director
Seoul National University Hospital
Chang-Keun Kim principal investigator
Inje University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexibuprofen and Ibuprofen in people with Fever and Respiratory Tract Infection, run by Inje University at 4 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 2 inclusion and 6 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 18 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
measure reduction in fever (time frame: measure temperature every hour for 3 hours then once again 3 days later). 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 18 Jan 2010.