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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00812422

Enrollment

260

Registered

2008-12-22

Start date

2008-02-29

Completion date

2009-05-31

Last updated

2010-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Respiratory Tract Infection

Keywords

Fever due to acute upper respiratory tract infection

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.

Interventions

DRUGDexibuprofen

one dose of Dexibuprofen 2.5 or 5 mg/kg

DRUGIbuprofen

one dose of Ibuprofen 5 or 10 mg/kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Months to 14 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026