A Multicenter, Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged = 13 Years. - ND

• Conditions: Treatment of Influenza [seasonal or pandemic (H1N1)2009]; MedDRA version: 9.1Level: PTClassification code 10022000; MedDRA version: 9.1Level: LLTClassification code 10022001

• Registration Number: EUCTR2010-020083-38-IT
• Lead Sponsor: F.Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-29
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

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

Inclusion Criteria

Patients are eligible for the study if they meet all of the following criteria: • Male and female adults and adolescents, 13 years of age and older • Diagnosis of influenza by virology testing or clinical diagnosis based on symptoms suggestive of influenza • = 96 hours between the onset of influenza-like illness and first dose of study medication • Patient is willing and able to comply with study requirements and give consent, or, if applicable, consent may be given by a parent, legal guardian or legal representative • Female patients who are pregnant may be enrolled only if the potential benefit justifies the potential risk to the fetus • Female patients who are lactating may be enrolled only if the potential benefit for the lactating mother justifies the potential risk to the breast-fed infant.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients meeting any of the following criteria are ineligible for participation in the study: • Patients with clinical evidence of severe hepatic decompensation at the time of randomization • Electrocardiogram showing acute ischemia or significant arrhythmia • Allergy to test medication • Patients taking probenicid medication within 7 days before starting study medication • Participation in a clinical trial or expanded access trial with an investigational drug in the 4 weeks prior to randomization.

Study & Design

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