A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain

Roche

Status and phase: Terminated; Phase 4

Conditions: Influenza

Treatments: Drug: Oseltamivir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01032837

NV22155

Details and patient eligibility

About

This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this study. Patients will be randomized to one of four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body weight-adjusted for pediatric patients.

Enrollment: 102 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric, adolescent and adult patients >/=1 year of age
• Fever >/=37.8 degrees C or at least one respiratory symptom (cough, coryza, sore throat, or rhinitis)
• Positive rapid diagnostic test for pandemic (H1N1) 2009 virus or influenza A in the 24 hours prior to the first dose of study drug
• </=96 hours between onset of influenza-like illness and first dose of oseltamivir

Exclusion criteria

• Currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, or hemofiltration
• History of chronic renal failure or clinical suspicion of renal failure at baseline
• Clinical evidence of hepatic compensation at the time of randomization
• Known HIV infection
• Vaccination with live attenuated influenza vaccine (LAIV) in the two weeks prior to first dose of study medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 4 patient groups

Oseltamivir standard dose 5 days

Experimental group

Description:

Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.

Treatment:

Drug: Oseltamivir

Drug: Placebo

Drug: Oseltamivir

Oseltamivir standard dose 10 days

Experimental group

Description:

Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.

Treatment:

Drug: Oseltamivir

Drug: Placebo

Drug: Oseltamivir

Oseltamivir high dose 5 days

Experimental group

Description:

Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.

Treatment:

Drug: Oseltamivir

Drug: Placebo

Drug: Oseltamivir

Oseltamivir high dose 10 days

Experimental group

Description:

Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.

Treatment:

Drug: Oseltamivir

Drug: Placebo

Drug: Oseltamivir