Clinical Trial Protocol Registry

Trial information

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

Status:
Completed
Protocol number:
NV22155
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific Title:
A randomized, multicenter trial of oseltamivir [Tamiflu] doses of 75 mg for 5 or 10 days versus 150 mg for 5 or 10 days to evaluate the effect on the duration of viral shedding in influenza patients with pandemic (H1N1) 2009
Brief summary:
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. The target sample size is 300-500 patients. Target sample size is 102.
Study phase:
IV
Study type:
Interventional; Treatment; Non-randomized; Active; Parallel; Safety/efficacy study
Conditions:
  • Influenza
Intervention type:
Drug
Intervention name:
Oseltamivir [Tamiflu]
Primary outcome:
  1. Efficacy on the duration of viral shedding Time frame: Day 11
Key secondary outcomes:
  1. Viral load, development of oseltamivir resistance, time to resolution of influenza symptoms (assessment by patients), clinical course of the influenza Time frame: Throughout study
  2. Safety and tolerability: AEs, laboratory parameters Time frame: AEs: Throughout study, laboratory assessment day 11
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
Gender:
Males or Females
Age limits:
Min: 1 year Max: N/A N/A
Accepts healthy volunteers:
No
Anticipated start date:
November, 2009
Trial registration date:
24.11.2009
Date last updated:
15.06.2011
This trial was conducted at the following locations:
U.S.A.
  • TUSCALOOSA, AL
  • JONESBORO, AR
  • PHOENIX, AZ
  • SCOTTSDALE, AZ
  • CARMICHAEL, CA
  • DOWNEY, CA
  • FOUNTAIN VALLEY, CA
  • HUNTINGTON BEACH, CA
  • LOMITA, CA
  • NATIONAL CITY, CA
  • PARAMOUNT, CA
  • SACRAMENTO, CA
  • SAN DIEGO, CA
  • COLORADO SPRINGS, CO
  • DELAND, FL
  • FLEMING ISLAND, FL
  • GAINESVILLE, FL
  • JACKSONVILLE, FL
  • LARGO, FL
  • MIAMI, FL
  • ORLANDO, FL
  • PEMBROKE PINES, FL
  • ST. CLOUD, FL
  • ATLANTA, GA
  • DUBUQUE, IA
  • IDAHO FALLS, ID
  • MERIDIAN, ID
  • CHICAGO, IL
  • INDIANAPOLIS, IN
  • NEWBURGH, IN
  • OVERLAND PARK, KS
  • BARDSTOWN, KY
  • MADISONVILLE, KY
  • LAKE CHARLES, LA
  • MANDEVILLE, LA
  • MELTAIRIE, LA
  • SHREVEPRT, LA
  • BROCKTON, MA
  • STEVENSVILLE, MI
  • BRIDGETON, MO
  • ST. LOUIS, MO
  • BOZEMAN, MT
  • ASHEBORO, NC
  • BURLINGTON, NC
  • GREENSBORO, NC
  • HARRISBURG, NC
  • MOORESVILLE, NC
  • MORGANTON, NC
  • RALEIGH, NC
  • SALISBURY, NC
  • BISMARCK, ND
  • BELLEVUE, NE
  • FREEMONT, NE
  • HADDON HEIGHTS, NJ
  • SICKLERVILLE, NJ
  • CAMILLUS, NY
  • ENDWELL, NY
  • JOHNSON CITY, NY
  • CANAL FULTON, OH
  • CINCINNATI, OH
  • CLEVELAND, OH
  • OKLAHOMA CITY, OK
  • ASHLAND, OR
  • MEDFORD, OR
  • COLLEGEVILLE, PA
  • ERIE, PA
  • JEFFERSON HILLS, PA
  • PITTSBURGH, PA
  • READING, PA
  • SCOTLAND, PA
  • UPLAND, PA
  • CHARLESTON, SC
  • MT. PLEASANT, SC
  • SIMPSONVILLE, SC
  • BRISTOL, TN
  • JACKSON, TN
  • JOHNSON CITY, TN
  • KINGSPORT, TN
  • BEDFORD, TX
  • CORPUS CHRISTI, TX
  • DALLAS, TX
  • EL PASO, TX
  • FORT WORTH, TX
  • NEW BRAUNFELS, TX
  • SAN ANTONIO, TX
  • TOMBALL, TX
  • CLINTON, UT
  • MAGNA, UT
  • SALT LAKE CITY, UT
  • SARATOGA SPRINGS, UT
  • WEST JORDAN, UT
  • RICHMOND, VA
  • VIENNA, VA
  • SPOKANE, WA

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