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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Oseltamivir (Drug); Oseltamivir (Drug); Placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Time to Cessation of Viral Shedding

Secondary outcome:

Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture

Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction

Change From Baseline in Influenza Titer Measured by Viral Culture

Number of Participants With Development of Oseltamivir-Resistant Influenza Virus

Time to Resolution of Fever

Time to Alleviation of All Clinical Symptoms - Children

Time to Alleviation of All Clinical Symptoms - Adults

Number of Participants Who Developed Secondary Illnesses During the Study

Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics

Eligibility

Minimum age: 1 Year. Maximum age: N/A. Gender(s): Both.

Criteria:

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

- 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

Locations and Contacts

Tuscaloosa, Alabama 35406, United States

Phoenix, Arizona 85016, United States

Phoenix, Arizona 85050, United States

Scottsdale, Arizona 85248, United States

Jonesboro, Arkansas 72401, United States

Carmichael, California 95608, United States

Downey, California 90241, United States

Fountain Valley, California 92708, United States

Huntington Beach, California 92647, United States

Lomita, California 90717, United States

National City, California 91950, United States

Paramount, California 90723, United States

Sacramento, California 95823, United States

San Diego, California 92103-6204, United States

San Diego, California 92120, United States

Colorado Springs, Colorado 80909, United States

Deland, Florida 32720, United States

Fleming Island, Florida 32003, United States

Gainesville, Florida 32607, United States

Jacksonville, Florida 32205, United States

Largo, Florida 33770, United States

Miami, Florida 33126, United States

Miami, Florida 33135, United States

Orlando, Florida 32806, United States

Pembroke Pines, Florida 33026, United States

St. Cloud, Florida 34769, United States

Atlanta, Georgia 30342, United States

Idaho Falls, Idaho 83404, United States

Meridian, Idaho 83642, United States

Chicago, Illinois 60622, United States

Indianapolis, Indiana 46268, United States

Newburgh, Indiana 47630, United States

Dubuque, Iowa 52002, United States

Overland Park, Kansas 66210, United States

Bardstown, Kentucky 40004, United States

Madisonville, Kentucky 42431, United States

Lake Charles, Louisiana 70601, United States

Mandeville, Louisiana 70471, United States

Meltairie, Louisiana 70006, United States

Shreveprt, Louisiana 71106, United States

Brockton, Massachusetts 02301, United States

Stevensville, Michigan 49127, United States

Bridgeton, Missouri 63044, United States

Saint Louis, Missouri 63141, United States

Bozeman, Montana 59715, United States

Bellevue, Nebraska 68005, United States

Freemont, Nebraska 68025, United States

Haddon Heights, New Jersey 08035, United States

Sicklerville, New Jersey 08081, United States

Camillus, New York 13031, United States

Endwell, New York 13780, United States

Johnson City, New York 13790, United States

Asheboro, North Carolina 27203, United States

Burlington, North Carolina 27215, United States

Greensboro, North Carolina 27408, United States

Harrisburg, North Carolina 28075, United States

Mooresville, North Carolina 28117, United States

Morganton, North Carolina 28655, United States

Raleigh, North Carolina 27612, United States

Salisbury, North Carolina 28144, United States

Bismarck, North Dakota 58501, United States

Canal Fulton, Ohio 44614, United States

Cincinnati, Ohio 45219, United States

Cleveland, Ohio 44122, United States

Cleveland, Ohio 44121, United States

Oklahoma City, Oklahoma 73112, United States

Ashland, Oregon 97520, United States

Medford, Oregon 97504, United States

Collegeville, Pennsylvania 19426, United States

Erie, Pennsylvania 16506, United States

Jefferson Hills, Pennsylvania 15025, United States

Pittsburgh, Pennsylvania 15236, United States

Pittsburgh, Pennsylvania 15241, United States

Reading, Pennsylvania 19606, United States

Scotland, Pennsylvania 17254, United States

Upland, Pennsylvania 19013, United States

Charleston, South Carolina 29412, United States

Mt. Pleasant, South Carolina 29464, United States

Simpsonville, South Carolina 29681, United States

Bristol, Tennessee 37620, United States

Jackson, Tennessee 38305, United States

Johnson City, Tennessee 37604, United States

Kingsport, Tennessee 37660, United States

Bedford, Texas 76022, United States

Corpus Christi, Texas 78411, United States

Dallas, Texas 75220, United States

El Paso, Texas 79912, United States

Fort Worth, Texas 76109, United States

New Braunfels, Texas 78130, United States

San Antonio, Texas 78238, United States

San Antonio, Texas 78215, United States

Tomball, Texas 77375, United States

Clinton, Utah 84015, United States

Magna, Utah 84044, United States

Salt Lake City, Utah 84107, United States

Saratoga Springs, Utah 84045, United States

West Jordan, Utah 84088, United States

Richmond, Virginia 23219, United States

Vienna, Virginia 22180, United States

Spokane, Washington 99204, United States

Additional Information

Starting date: November 2009
Last updated: September 18, 2012

Page last updated: August 23, 2015

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