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

September 18, 2012 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35406
    • Arizona
      • Phoenix, Arizona, United States, 85050
      • Phoenix, Arizona, United States, 85016
      • Scottsdale, Arizona, United States, 85248
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
    • 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, 92120
      • San Diego, California, United States, 92103-6204
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
    • 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
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
      • Meridian, Idaho, United States, 83642
    • Illinois
      • Chicago, Illinois, United States, 60622
    • Indiana
      • Indianapolis, Indiana, United States, 46268
      • Newburgh, Indiana, United States, 47630
    • Iowa
      • Dubuque, Iowa, United States, 52002
    • Kansas
      • Overland Park, Kansas, United States, 66210
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
      • Madisonville, Kentucky, United States, 42431
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
      • Mandeville, Louisiana, United States, 70471
      • Meltairie, Louisiana, United States, 70006
      • Shreveprt, Louisiana, United States, 71106
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
    • Michigan
      • Stevensville, Michigan, United States, 49127
    • Missouri
      • Bridgeton, Missouri, United States, 63044
      • Saint Louis, Missouri, United States, 63141
    • Montana
      • Bozeman, Montana, United States, 59715
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
      • Freemont, Nebraska, United States, 68025
    • New Jersey
      • Haddon Heights, New Jersey, United States, 08035
      • Sicklerville, New Jersey, United States, 08081
    • New York
      • Camillus, New York, United States, 13031
      • Endwell, New York, United States, 13780
      • Johnson City, New York, United States, 13790
    • 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
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
    • Ohio
      • Canal Fulton, Ohio, United States, 44614
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44122
      • Cleveland, Ohio, United States, 44121
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
    • Oregon
      • Ashland, Oregon, United States, 97520
      • Medford, Oregon, United States, 97504
    • 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
    • South Carolina
      • Charleston, South Carolina, United States, 29412
      • Mt. Pleasant, South Carolina, United States, 29464
      • Simpsonville, South Carolina, United States, 29681
    • Tennessee
      • Bristol, Tennessee, United States, 37620
      • Jackson, Tennessee, United States, 38305
      • Johnson City, Tennessee, United States, 37604
      • Kingsport, Tennessee, United States, 37660
    • 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
    • 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
    • Virginia
      • Richmond, Virginia, United States, 23219
      • Vienna, Virginia, United States, 22180
    • Washington
      • Spokane, Washington, United States, 99204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Tamiflu
Drug: Oseltamivir
Pediatric suspension for participants aged ≤ 12 years.
Other Names:
  • 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 Names:
  • Tamiflu
Drug: Oseltamivir
Pediatric suspension for participants aged ≤ 12 years.
Other Names:
  • 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 Names:
  • Tamiflu
Drug: Oseltamivir
Pediatric suspension for participants aged ≤ 12 years.
Other Names:
  • 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 Names:
  • Tamiflu
Drug: Oseltamivir
Pediatric suspension for participants aged ≤ 12 years.
Other Names:
  • Tamiflu
Drug: Placebo
Matching placebo provided as capsules and as a suspension.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1 to Day 40

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and Days 3, 6, 8, 11, 15 and 40
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.
Baseline and Days 3, 6, 8, 11, 15 and 40
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).
Baseline, Days 2 through 15
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.
40 days
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.
Day 1 through Day 40
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.
Day 1 to Day 40
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.
Day 1 to Day 40
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.
Day 1 through Day 40
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.
Day 1 through Day 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NV22155

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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