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Completed

NCT Number: NCT00812422

The Efficacy and Safety of Dexibuprofen Syrup

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.

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Key information

Conditions

Fever Body Temperature Changes Infections Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infection Respiratory Tract Infections Signs and Symptoms

Age range

6 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexibuprofen

Drug

one dose of Dexibuprofen 2.5 or 5 mg/kg

Ibuprofen

Drug

one dose of Ibuprofen 5 or 10 mg/kg

Primary outcomes

  1. measure reduction in fever

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

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

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)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 22, 2008
Registry last updated
Jan 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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