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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

Tracking Information
First Submitted Date  ICMJE December 10, 2009
First Posted Date  ICMJE December 16, 2009
Results First Submitted Date  ICMJE July 12, 2012
Results First Posted Date  ICMJE August 20, 2012
Last Update Posted Date October 2, 2012
Study Start Date  ICMJE November 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2009)
Efficacy on the duration of viral shedding [ Time Frame: Day 11 ]
Change History Complete list of historical versions of study NCT01032837 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2009)
  • Viral load, development of oseltamivir resistance, time to resolution of influenza symptoms (assessment by patients), clinical course of the influenza [ Time Frame: Throughout study ]
  • Safety and tolerability: AEs, laboratory parameters [ Time Frame: AEs: Throughout study, laboratory assessment day 11 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Influenza
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Oseltamivir
    • Drug: Oseltamivir
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Oseltamivir
    • Drug: Oseltamivir
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Oseltamivir
    • Drug: Oseltamivir
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Oseltamivir
    • Drug: Oseltamivir
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 20, 2011)
102
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2009)
400
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01032837
Other Study ID Numbers  ICMJE NV22155
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP