The Efficacy and Safety of Dexibuprofen Syrup
Information source: Inje University
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fever; Respiratory Tract Infection
Intervention: Dexibuprofen (Drug); Dexibuprofen (Drug); Ibuprofen (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Inje University Official(s) and/or principal investigator(s):
Young Yull Koh, Study Director, Affiliation: Seoul National University Hospital
Chang-Keun Kim, Principal Investigator, Affiliation: Inje University Sanggye Paik Hospital
Overall contact:
Young Yull Koh, MD, PhD, Phone: 82-2-2072-3631, Email: kohyy@plaza.snu.ac.kr
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.
Clinical Details
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)
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: measure reduction in fever
Secondary outcome: determine safety of dexibuprofen by unwanted reaction, clinical laboratory test and physical examination.
Eligibility
Minimum age: 6 Months.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Common cold with fever
- Age 6 months to 14 years
Exclusion Criteria:
- Gastric ulcer
- Bleeding tendency
- Liver disease
- Kidney disease
- Hypertension
- Hypersensitivity to the drug
Locations and Contacts
Young Yull Koh, MD, PhD, Phone: 82-2-2072-3631, Email: kohyy@plaza.snu.ac.kr
Asan Medical Center, Seoul, Korea, Republic of; Recruiting
Korea University Hospital, Seoul, Korea, Republic of; Recruiting
Kyung Hee University Hospital, Seoul, Korea, Republic of; Recruiting
Inje University Sanggye Paik Hospital, Seoul, Korea, Republic of; Recruiting
Additional Information
Starting date: February 2008
Ending date: May 2009
Last updated: December 19, 2008
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