Pediatric Fever

• Conditions: fever; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2010-024387-17-PL
• Lead Sponsor: Cumberland Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-12
• Last Update Posted: 25 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Parent or Legal Guardian able to provide written Informed Consent prior to participation in the study
2. Be between birth (28 weeks to < 40 weeks gestational age) to = 16 years
3. Inpatient status: currently inpatient or have admission scheduled and will soon become an inpatient
4. Febrile (temperature > 101.0°F

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Inadequate IV access
2. Have received antipyretic drug therapy within 2 hours before dosing
3. Have any history of allergy or hypersensitivity to NSAIDs, aspirin, or APAP
4. Have received another investigational drug within the past 30 days
5. Be otherwise unsuitable for the study, in the opinion of the Investigator
6. Fever due to Hyperthermia
7. Pregnant or nursing

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified