The Efficacy and Safety of Dexibuprofen Syrup

Phase 3

Completed

• Conditions: Fever; Respiratory Tract Infection
• Interventions: Drug: Dexibuprofen; Drug: Ibuprofen

• Registration Number: NCT00812422
• Lead Sponsor: Inje University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-15
• Last Update Posted: 2010-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexibuprofen 1	Dexibuprofen	Dexibuprofen 2.5 or 5 mg/kg
Dexibuprofen 2	Dexibuprofen	Dexibuprofen 3.5 or 7 mg/kg
Ibuprofen	Ibuprofen	Ibuprofen 5 or 10 mg/kg

Primary Outcome Measures

Name	Time	Method
measure reduction in fever	measure temperature every hour for 3 hours then once again 3 days later

Secondary Outcome Measures

Name	Time	Method
determine safety of dexibuprofen by unwanted reaction, clinical laboratory test and physical examination.	every hour for 3 hours (unwanted reaction). 3 days later (clinical laboratory test and physical examination).

Trial Locations

Locations (4)

Inje University Sanggye Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Hospital; 🇰🇷 Seoul, Korea, Republic of