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

This study has been terminated.
(Study closed prematurely due to the end of the influenza (H1N1) 2009 pandemic)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01032837
First received: December 10, 2009
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
Results First Received: July 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Influenza
Interventions: Drug: Oseltamivir
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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 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 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 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.

Participant Flow:   Overall Study
    Oseltamivir Standard Dose 5 Days     Oseltamivir Standard Dose 10 Days     Oseltamivir High Dose 5 Days     Oseltamivir High Dose 10 Days  
STARTED     26     26     25     25  
Intent-to-Treat     26 [1]   26 [1]   25 [1]   24 [1]
COMPLETED     26 [2]   23 [2]   24 [2]   22 [2]
NOT COMPLETED     0     3     1     3  
Adverse event/internal illness                 0                 1                 0                 1  
Withdrew consent                 0                 2                 0                 1  
Failed to return                 0                 0                 1                 0  
Refused treatment                 0                 0                 0                 1  
[1] All patients randomized who received at least one dose of study medication.
[2] Represents patients who completed treatment.



  Baseline Characteristics
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Reporting Groups
  Description
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 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 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 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.
Total Total of all reporting groups

Baseline Measures
    Oseltamivir Standard Dose 5 Days     Oseltamivir Standard Dose 10 Days     Oseltamivir High Dose 5 Days     Oseltamivir High Dose 10 Days     Total  
Number of Participants  
[units: participants]
 		  26     26     25     24     101  
Age, Customized [1]
[units: participants]
 		         
1 to <13 years     7     7     7     6     27  
13 to ≤18 years     3     2     5     3     13  
>18 years     16     17     13     15     61  
Gender  
[units: participants]
 		         
Female     13     15     14     12     54  
Male     13     11     11     12     47  
Race/Ethnicity, Customized  
[units: participants]
 		         
Asian     1     2     1     0     4  
Black     2     1     3     4     10  
White     23     23     20     20     86  
White/Black     0     0     1     0     1  
[1] Overall number of baseline participants is based on the Intent-to-Treat population.



  Outcome Measures
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1.  Primary:   Time to Cessation of Viral Shedding   [ Time Frame: Day 1 to Day 40 ]
  Show Outcome Measure 1

2.  Secondary:   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 ]
  Show Outcome Measure 2

3.  Secondary:   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 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Influenza Titer Measured by Viral Culture   [ Time Frame: Baseline, Days 2 through 15 ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With Development of Oseltamivir-Resistant Influenza Virus   [ Time Frame: 40 days ]
  Show Outcome Measure 5

6.  Secondary:   Time to Resolution of Fever   [ Time Frame: Day 1 through Day 40 ]
  Show Outcome Measure 6

7.  Secondary:   Time to Alleviation of All Clinical Symptoms - Children   [ Time Frame: Day 1 to Day 40 ]
  Show Outcome Measure 7

8.  Secondary:   Time to Alleviation of All Clinical Symptoms - Adults   [ Time Frame: Day 1 to Day 40 ]
  Show Outcome Measure 8

9.  Secondary:   Number of Participants Who Developed Secondary Illnesses During the Study   [ Time Frame: Day 1 through Day 40 ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics   [ Time Frame: Day 1 through Day 40 ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01032837     History of Changes
Other Study ID Numbers: NV22155
Study First Received: December 10, 2009
Results First Received: July 12, 2012
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration