Acute Upper Respiratory Infection, Fever
Conditions
Keywords
Pelubi, Pelubiprofen, Loxoprofen, Anti-pyretic, Fever
Brief 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.
Interventions
DRUGPelubiprofen
DRUGLoxoprofen
Sponsors
Daewon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over 15 years old 2. Male and Female 3. Patients with fever over 38.0°C due to cold (acute upper respiratory tract infection) 4. Patients with upper respiratory tract infection outbreak within 2 days and who did not received drug administration 5. Subjects who voluntarily or legal guardian agreed with written consent
Exclusion criteria
1. Fever reducer administration Within 4 hours from the screening point 2. Any incidence of febrile crisis from the past six months 3. Patients with Ulcers, gastrointestinal disorders which are confirmed by endoscopy 4. Patients with continuously administrating gastrointestinal disorder related drug 5. Patients with severe blood damage 6. Severe hepatic impairment (ALT, AST value more than 2 times the upper limit of the normal range) 7. With severe renal impairment (serum creatinine value is more than 2 times the upper limit of the normal range) 8. Patients with severe left ventricular dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Body temperature from baseline | 0, 0.5, 1, 1.5, 2, 3, 4, 6 Hour |
Countries
South Korea
Outcome results
None listed