NCT00812422

The Efficacy and Safety of Dexibuprofen Syrup

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Inje University · Academic / Other
• Sex: All
• Age: 6 Months – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fever
• Respiratory Tract Infection

Interventions

Type	Name	Description
DRUG	Dexibuprofen	one dose of Dexibuprofen 2.5 or 5 mg/kg
DRUG	Dexibuprofen	one dose of Dexibuprofen 3.5 or 7 mg/kg
DRUG	Ibuprofen	one dose of Ibuprofen 5 or 10 mg/kg

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-12-22
• Last updated: 2010-01-18

Locations

4 sites across 1 country: South Korea