The Efficacy and Safety of Dexibuprofen Syrup

Inje University

Status and phase: Completed; Phase 3

Conditions: Fever; Respiratory Tract Infection

Treatments: Drug: Ibuprofen; Drug: Dexibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT00812422

AG_DIBU_2007

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 6 months to 14 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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260 participants in 3 patient groups

Dexibuprofen 1

Experimental group

Description:

Dexibuprofen 2.5 or 5 mg/kg

Treatment:

Drug: Dexibuprofen

Drug: Dexibuprofen

Dexibuprofen 2

Experimental group

Description:

Dexibuprofen 3.5 or 7 mg/kg

Treatment:

Drug: Dexibuprofen

Drug: Dexibuprofen

Ibuprofen

Active Comparator group

Description:

Ibuprofen 5 or 10 mg/kg

Treatment:

Drug: Ibuprofen