The Efficacy and Safety of Dexibuprofen Syrup

Inje University260 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

260

Conditions

Fever Respiratory Tract Infection

Interventions

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 14 Years

Medical Language ↔ Plain English

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 (4)

Asan Medical Center

Seoul, South Korea

Inje University Sanggye Paik Hospital

Seoul, South Korea

Korea University Hospital

Seoul, South Korea

Kyung Hee University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

measure reduction in fever

Time frame: measure temperature every hour for 3 hours then once again 3 days later

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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