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Trial record 31 of 118 for:    oseltamivir

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

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ClinicalTrials.gov Identifier: NCT01032837
Recruitment Status : Terminated (Study closed prematurely due to the end of the influenza (H1N1) 2009 pandemic)
First Posted : December 16, 2009
Results First Posted : August 20, 2012
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Influenza Drug: Oseltamivir Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: 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.
Drug: Oseltamivir
Oseltamivir capsules for participants ≥ 13 years.
Other Name: Tamiflu

Drug: Oseltamivir
Pediatric suspension for participants aged ≤ 12 years.
Other Name: Tamiflu

Drug: Placebo
Matching placebo provided as capsules and as a suspension.

Experimental: 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.
Drug: Oseltamivir
Oseltamivir capsules for participants ≥ 13 years.
Other Name: Tamiflu

Drug: Oseltamivir
Pediatric suspension for participants aged ≤ 12 years.
Other Name: Tamiflu

Drug: Placebo
Matching placebo provided as capsules and as a suspension.

Experimental: 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.
Drug: Oseltamivir
Oseltamivir capsules for participants ≥ 13 years.
Other Name: Tamiflu

Drug: Oseltamivir
Pediatric suspension for participants aged ≤ 12 years.
Other Name: Tamiflu

Drug: Placebo
Matching placebo provided as capsules and as a suspension.

Experimental: 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.
Drug: Oseltamivir
Oseltamivir capsules for participants ≥ 13 years.
Other Name: Tamiflu

Drug: Oseltamivir
Pediatric suspension for participants aged ≤ 12 years.
Other Name: Tamiflu

Drug: Placebo
Matching placebo provided as capsules and as a suspension.




Primary Outcome Measures :
  1. Time to Cessation of Viral Shedding [ Time Frame: Day 1 to Day 40 ]
    The time to cessation of viral shedding was measured by viral culture and defined as the time from treatment initiation to the time of the first negative culture with no subsequent positive cultures. Any patient with a positive culture at the last sample time was censored at that time point. Median time to cessation was estimated from the Kaplan-Meier curve.


Secondary Outcome Measures :
  1. Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture [ Time Frame: Baseline and Days 3, 6, 8, 11, 15 and 40 ]
    Viral shedding was measured by viral culture from samples obtained from nasal and throat swabs and performed by the central laboratory.

  2. Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction [ Time Frame: Baseline and Days 3, 6, 8, 11, 15 and 40 ]
    Viral shedding was measured by reverse transcriptase polymerase chain reaction (RT-PCR) from samples obtained from nasal and throat swabs and performed by the central laboratory.

  3. Change From Baseline in Influenza Titer Measured by Viral Culture [ Time Frame: Baseline, Days 2 through 15 ]
    Influenza virus titer measured by viral culture and expressed on a Log10 scale of the 50% Tissue Culture Infective Dose (TCID50; amount of virus required to kill 50% of inoculated tissue culture cells).

  4. Number of Participants With Development of Oseltamivir-Resistant Influenza Virus [ Time Frame: 40 days ]
    The last positive viral isolate from each patient was tested for reduced sensitivity to oseltamivir. Phenotypic assay was performed to determine the susceptibility of the last positive viral isolate from each patient. If required, a genotypic assay to determine the contribution of both the neuraminidase (NA) and hemagglutinin (HA) genes to decreased susceptibility was also performed.

  5. Time to Resolution of Fever [ Time Frame: Day 1 through Day 40 ]
    Temperature was recorded by the patient in a diary twice daily for 10 days and once daily thereafter. Fever was defined as a body temperature greater than or including 37.8 degrees Celsius (or ≥ 100.04 Fahrenheit). Time to resolution of fever was defined as the total number of hours from the first dose of study medication to the first time at which temperature is ≤ 37.2 degrees Celsius and lasts at least 21.5 hours. Patients who were still febrile at the end of the study period were censored at that time.

  6. Time to Alleviation of All Clinical Symptoms - Children [ Time Frame: Day 1 to Day 40 ]
    Daily influenza-like symptoms (such as poor appetite, irritability, low energy, nasal congestion, runny nose etc) were recorded in a diary on a scale from 0 (no problem) to 3 (major problem). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'no problem' or 'minor problem' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.

  7. Time to Alleviation of All Clinical Symptoms - Adults [ Time Frame: Day 1 to Day 40 ]
    Daily influenza-like symptoms (such as nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills) were recorded in a diary on a scale from 0 (absent) to 3 (severe). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'absent' or 'mild' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.

  8. Number of Participants Who Developed Secondary Illnesses During the Study [ Time Frame: Day 1 through Day 40 ]
    The number of participants who developed secondary illnesses due to influenza, including four pre-defined adverse events: otitis media, bronchitis, pneumonia, or sinusitis at any time during the study.

  9. Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics [ Time Frame: Day 1 through Day 40 ]
    The number of participants who developed secondary illnesses due to influenza, including otitis media, bronchitis, pneumonia, or sinusitis at any time during the study which were treated with antibiotics.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • </=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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032837


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Locations
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United States, Alabama
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
Phoenix, Arizona, United States, 85016
Phoenix, Arizona, United States, 85050
Scottsdale, Arizona, United States, 85248
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
United States, California
Carmichael, California, United States, 95608
Downey, California, United States, 90241
Fountain Valley, California, United States, 92708
Huntington Beach, California, United States, 92647
Lomita, California, United States, 90717
National City, California, United States, 91950
Paramount, California, United States, 90723
Sacramento, California, United States, 95823
San Diego, California, United States, 92103-6204
San Diego, California, United States, 92120
United States, Colorado
Colorado Springs, Colorado, United States, 80909
United States, Florida
Deland, Florida, United States, 32720
Fleming Island, Florida, United States, 32003
Gainesville, Florida, United States, 32607
Jacksonville, Florida, United States, 32205
Largo, Florida, United States, 33770
Miami, Florida, United States, 33126
Miami, Florida, United States, 33135
Orlando, Florida, United States, 32806
Pembroke Pines, Florida, United States, 33026
St. Cloud, Florida, United States, 34769
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Idaho
Idaho Falls, Idaho, United States, 83404
Meridian, Idaho, United States, 83642
United States, Illinois
Chicago, Illinois, United States, 60622
United States, Indiana
Indianapolis, Indiana, United States, 46268
Newburgh, Indiana, United States, 47630
United States, Iowa
Dubuque, Iowa, United States, 52002
United States, Kansas
Overland Park, Kansas, United States, 66210
United States, Kentucky
Bardstown, Kentucky, United States, 40004
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Lake Charles, Louisiana, United States, 70601
Mandeville, Louisiana, United States, 70471
Meltairie, Louisiana, United States, 70006
Shreveprt, Louisiana, United States, 71106
United States, Massachusetts
Brockton, Massachusetts, United States, 02301
United States, Michigan
Stevensville, Michigan, United States, 49127
United States, Missouri
Bridgeton, Missouri, United States, 63044
Saint Louis, Missouri, United States, 63141
United States, Montana
Bozeman, Montana, United States, 59715
United States, Nebraska
Bellevue, Nebraska, United States, 68005
Freemont, Nebraska, United States, 68025
United States, New Jersey
Haddon Heights, New Jersey, United States, 08035
Sicklerville, New Jersey, United States, 08081
United States, New York
Camillus, New York, United States, 13031
Endwell, New York, United States, 13780
Johnson City, New York, United States, 13790
United States, North Carolina
Asheboro, North Carolina, United States, 27203
Burlington, North Carolina, United States, 27215
Greensboro, North Carolina, United States, 27408
Harrisburg, North Carolina, United States, 28075
Mooresville, North Carolina, United States, 28117
Morganton, North Carolina, United States, 28655
Raleigh, North Carolina, United States, 27612
Salisbury, North Carolina, United States, 28144
United States, North Dakota
Bismarck, North Dakota, United States, 58501
United States, Ohio
Canal Fulton, Ohio, United States, 44614
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44121
Cleveland, Ohio, United States, 44122
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Ashland, Oregon, United States, 97520
Medford, Oregon, United States, 97504
United States, Pennsylvania
Collegeville, Pennsylvania, United States, 19426
Erie, Pennsylvania, United States, 16506
Jefferson Hills, Pennsylvania, United States, 15025
Pittsburgh, Pennsylvania, United States, 15236
Pittsburgh, Pennsylvania, United States, 15241
Reading, Pennsylvania, United States, 19606
Scotland, Pennsylvania, United States, 17254
Upland, Pennsylvania, United States, 19013
United States, South Carolina
Charleston, South Carolina, United States, 29412
Mt. Pleasant, South Carolina, United States, 29464
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Bristol, Tennessee, United States, 37620
Jackson, Tennessee, United States, 38305
Johnson City, Tennessee, United States, 37604
Kingsport, Tennessee, United States, 37660
United States, Texas
Bedford, Texas, United States, 76022
Corpus Christi, Texas, United States, 78411
Dallas, Texas, United States, 75220
El Paso, Texas, United States, 79912
Fort Worth, Texas, United States, 76109
New Braunfels, Texas, United States, 78130
San Antonio, Texas, United States, 78215
San Antonio, Texas, United States, 78238
Tomball, Texas, United States, 77375
United States, Utah
Clinton, Utah, United States, 84015
Magna, Utah, United States, 84044
Salt Lake City, Utah, United States, 84107
Saratoga Springs, Utah, United States, 84045
West Jordan, Utah, United States, 84088
United States, Virginia
Richmond, Virginia, United States, 23219
Vienna, Virginia, United States, 22180
United States, Washington
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01032837     History of Changes
Other Study ID Numbers: NV22155
First Posted: December 16, 2009    Key Record Dates
Results First Posted: August 20, 2012
Last Update Posted: October 2, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Oseltamivir
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action