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InfluenzaPhase 4NCT01032837

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

A Phase 4 study testing Oseltamivir in people with Influenza, run by Hoffmann-La Roche at 100 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year and older
Conditions the study is for
Influenza
What is being tested?
Oseltamivir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
100 sitesUnited States
Study dates
Nov 2009to Oct 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

100 sites in 1 country.

100 sites in 1 country

United States100 sites

  • Study site

    Asheboro, North Carolina, 27203

  • Study site

    Ashland, Oregon, 97520

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Bardstown, Kentucky, 40004

  • Study site

    Bedford, Texas, 76022

  • Study site

    Bellevue, Nebraska, 68005

  • Study site

    Bismarck, North Dakota, 58501

  • Study site

    Bozeman, Montana, 59715

  • Study site

    Bridgeton, Missouri, 63044

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Brockton, Massachusetts, 02301

  • Study site

    Burlington, North Carolina, 27215

  • Study site

    Camillus, New York, 13031

  • Study site

    Canal Fulton, Ohio, 44614

  • Study site

    Carmichael, California, 95608

  • Study site

    Charleston, South Carolina, 29412

  • Study site

    Chicago, Illinois, 60622

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cleveland, Ohio, 44121

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Clinton, Utah, 84015

  • Study site

    Collegeville, Pennsylvania, 19426

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Corpus Christi, Texas, 78411

  • Study site

    Dallas, Texas, 75220

  • Study site

    DeLand, Florida, 32720

  • Study site

    Downey, California, 90241

  • Study site

    Dubuque, Iowa, 52002

  • Study site

    El Paso, Texas, 79912

  • Study site

    Endwell, New York, 13780

  • Study site

    Erie, Pennsylvania, 16506

  • Study site

    Fleming Island, Florida, 32003

  • Study site

    Fort Worth, Texas, 76109

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Freemont, Nebraska, 68025

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Greensboro, North Carolina, 27408

  • Study site

    Haddon Heights, New Jersey, 08035

  • Study site

    Harrisburg, North Carolina, 28075

  • Study site

    Huntington Beach, California, 92647

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Indianapolis, Indiana, 46268

  • Study site

    Jackson, Tennessee, 38305

  • Study site

    Jacksonville, Florida, 32205

  • Study site

    Jefferson Hills, Pennsylvania, 15025

  • Study site

    Johnson City, New York, 13790

  • Study site

    Johnson City, Tennessee, 37604

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Lake Charles, Louisiana, 70601

  • Study site

    Largo, Florida, 33770

  • Study site

    Lomita, California, 90717

  • Study site

    Madisonville, Kentucky, 42431

  • Study site

    Magna, Utah, 84044

  • Study site

    Mandeville, Louisiana, 70471

  • Study site

    Medford, Oregon, 97504

  • Study site

    Meltairie, Louisiana, 70006

  • Study site

    Meridian, Idaho, 83642

  • Study site

    Miami, Florida, 33126

  • Study site

    Miami, Florida, 33135

  • Study site

    Mooresville, North Carolina, 28117

  • Study site

    Morganton, North Carolina, 28655

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    National City, California, 91950

  • Study site

    New Braunfels, Texas, 78130

  • Study site

    Newburgh, Indiana, 47630

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Orlando, Florida, 32806

  • Study site

    Overland Park, Kansas, 66210

  • Study site

    Paramount, California, 90723

  • Study site

    Pembroke Pines, Florida, 33026

  • Study site

    Phoenix, Arizona, 85016

  • Study site

    Phoenix, Arizona, 85050

  • Study site

    Pittsburgh, Pennsylvania, 15236

  • Study site

    Pittsburgh, Pennsylvania, 15241

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Reading, Pennsylvania, 19606

  • Study site

    Richmond, Virginia, 23219

  • Study site

    Sacramento, California, 95823

  • Study site

    Saint Cloud, Florida, 34769

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Antonio, Texas, 78238

  • Study site

    San Diego, California, 92103-6204

  • Study site

    San Diego, California, 92120

  • Study site

    Saratoga Springs, Utah, 84045

  • Study site

    Scotland, Pennsylvania, 17254

  • Study site

    Scottsdale, Arizona, 85248

  • Study site

    Shreveprt, Louisiana, 71106

  • Study site

    Sicklerville, New Jersey, 08081

  • Study site

    Simpsonville, South Carolina, 29681

  • Study site

    Spokane, Washington, 99204

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Stevensville, Michigan, 49127

  • Study site

    Tomball, Texas, 77375

  • Study site

    Tuscaloosa, Alabama, 35406

  • Study site

    Upland, Pennsylvania, 19013

  • Study site

    Vienna, Virginia, 22180

  • Study site

    West Jordan, Utah, 84088

Other trials in United States

About this study

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

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.

Conditions
Influenza
Being tested
Oseltamivir, Placebo
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OseltamivirDrug

    Also called Tamiflu

    Oseltamivir capsules for participants ≥ 13 years.

  • OseltamivirDrug

    Also called Tamiflu

    Pediatric suspension for participants aged ≤ 12 years.

  • PlaceboDrug

    Matching placebo provided as capsules and as a suspension.

Study groups in NCT01032837
Study groupRoleWhat they receive
Oseltamivir standard dose 5 daysExperimentalAdults 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.
Receives: Drug: Oseltamivir; Drug: Placebo
Oseltamivir standard dose 10 daysExperimentalAdults 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.
Receives: Drug: Oseltamivir; Drug: Placebo
Oseltamivir high dose 5 daysExperimentalAdults 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.
Receives: Drug: Oseltamivir; Drug: Placebo
Oseltamivir high dose 10 daysExperimentalAdults 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.
Receives: Drug: Oseltamivir; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Cessation of Viral Shedding

    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.

    Measured: Day 1 to Day 40

Secondary outcomes (9)

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

    Viral shedding was measured by viral culture from samples obtained from nasal and throat swabs and performed by the central laboratory.

    Measured: Baseline and Days 3, 6, 8, 11, 15 and 40

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

    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.

    Measured: Baseline and Days 3, 6, 8, 11, 15 and 40

  3. Change From Baseline in Influenza Titer Measured by Viral Culture

    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).

    Measured: Baseline, Days 2 through 15

  4. Number of Participants With Development of Oseltamivir-Resistant Influenza Virus

    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.

    Measured: 40 days

  5. Time to Resolution of Fever

    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.

    Measured: Day 1 through Day 40

  6. Time to Alleviation of All Clinical Symptoms - Children

    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.

    Measured: Day 1 to Day 40

  7. Time to Alleviation of All Clinical Symptoms - Adults

    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.

    Measured: Day 1 to Day 40

  8. Number of Participants Who Developed Secondary Illnesses During the Study

    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.

    Measured: Day 1 through Day 40

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

    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.

    Measured: Day 1 through Day 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionOct 2010
  4. Study completionOct 2010

Why it stopped: Study closed prematurely due to the end of the influenza (H1N1) 2009 pandemic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01032837
Sponsor's protocol ID
NV22155
Status last verified
Sep 2012
First submitted
10 Dec 2009
Last updated
2 Oct 2012

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oseltamivir in people with Influenza, run by Hoffmann-La Roche at 100 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Cessation of Viral Shedding (time frame: Day 1 to Day 40). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01032837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012.

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