A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain
NCT ID: NCT01032837
Last Updated: 2012-10-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
102 participants
INTERVENTIONAL
2009-11-30
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Oseltamivir standard dose 5 days
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.
Oseltamivir
Oseltamivir capsules for participants ≥ 13 years.
Oseltamivir
Pediatric suspension for participants aged ≤ 12 years.
Placebo
Matching placebo provided as capsules and as a suspension.
Oseltamivir standard dose 10 days
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.
Oseltamivir
Oseltamivir capsules for participants ≥ 13 years.
Oseltamivir
Pediatric suspension for participants aged ≤ 12 years.
Placebo
Matching placebo provided as capsules and as a suspension.
Oseltamivir high dose 5 days
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.
Oseltamivir
Oseltamivir capsules for participants ≥ 13 years.
Oseltamivir
Pediatric suspension for participants aged ≤ 12 years.
Placebo
Matching placebo provided as capsules and as a suspension.
Oseltamivir high dose 10 days
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.
Oseltamivir
Oseltamivir capsules for participants ≥ 13 years.
Oseltamivir
Pediatric suspension for participants aged ≤ 12 years.
Placebo
Matching placebo provided as capsules and as a suspension.
Interventions
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Oseltamivir
Oseltamivir capsules for participants ≥ 13 years.
Oseltamivir
Pediatric suspension for participants aged ≤ 12 years.
Placebo
Matching placebo provided as capsules and as a suspension.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Tuscaloosa, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Jonesboro, Arkansas, United States
Carmichael, California, United States
Downey, California, United States
Fountain Valley, California, United States
Huntington Beach, California, United States
Lomita, California, United States
National City, California, United States
Paramount, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
DeLand, Florida, United States
Fleming Island, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Saint Cloud, Florida, United States
Atlanta, Georgia, United States
Idaho Falls, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Newburgh, Indiana, United States
Dubuque, Iowa, United States
Overland Park, Kansas, United States
Bardstown, Kentucky, United States
Madisonville, Kentucky, United States
Lake Charles, Louisiana, United States
Mandeville, Louisiana, United States
Meltairie, Louisiana, United States
Shreveprt, Louisiana, United States
Brockton, Massachusetts, United States
Stevensville, Michigan, United States
Bridgeton, Missouri, United States
St Louis, Missouri, United States
Bozeman, Montana, United States
Bellevue, Nebraska, United States
Freemont, Nebraska, United States
Haddon Heights, New Jersey, United States
Sicklerville, New Jersey, United States
Camillus, New York, United States
Endwell, New York, United States
Johnson City, New York, United States
Asheboro, North Carolina, United States
Burlington, North Carolina, United States
Greensboro, North Carolina, United States
Harrisburg, North Carolina, United States
Mooresville, North Carolina, United States
Morganton, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Bismarck, North Dakota, United States
Canal Fulton, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Ashland, Oregon, United States
Medford, Oregon, United States
Collegeville, Pennsylvania, United States
Erie, Pennsylvania, United States
Jefferson Hills, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Reading, Pennsylvania, United States
Scotland, Pennsylvania, United States
Upland, Pennsylvania, United States
Charleston, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
Bristol, Tennessee, United States
Jackson, Tennessee, United States
Johnson City, Tennessee, United States
Kingsport, Tennessee, United States
Bedford, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
New Braunfels, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Clinton, Utah, United States
Magna, Utah, United States
Salt Lake City, Utah, United States
Saratoga Springs, Utah, United States
West Jordan, Utah, United States
Richmond, Virginia, United States
Vienna, Virginia, United States
Spokane, Washington, United States
Countries
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Other Identifiers
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NV22155
Identifier Type: -
Identifier Source: org_study_id