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

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Roche

Status and phase

Terminated
Phase 4

Conditions

Influenza

Treatments

Drug: Placebo
Drug: Oseltamivir

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

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
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
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
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

Trial contacts and locations

100

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Data sourced from clinicaltrials.gov

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