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A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00949533
First Posted: July 30, 2009
Last Update Posted: August 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
Results First Submitted: April 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Influenza
Intervention: Drug: Oseltamivir

  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
Out of 199 participants, 162 were considered as screening failures, mainly due to the negative result detected by the quick test for Influenza A Antigen. Therefore, 37 participants included in the study.

Reporting Groups
  Description
Standard Dose Oseltamivir (Tamiflu) capsule was administered orally at a dose of 75 milligrams (mg) twice a day (BID) in adult participants and children received oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter [mg/mL]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
Double Dose Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.

Participant Flow:   Overall Study
    Standard Dose   Double Dose
STARTED   19   18 
COMPLETED   19   17 
NOT COMPLETED   0   1 
Lost to Follow-up                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention-to-treat (ITT) population included all enrolled participants who received at least one dose of the study drug.

Reporting Groups
  Description
Standard Dose Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
Double Dose Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
Total Total of all reporting groups

Baseline Measures
   Standard Dose   Double Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   18   37 
Age 
[Units: Years]
Mean (Standard Deviation)
 21.6  (11.0)   22.0  (12.7)   21.8  (11.7) 
Gender 
[Units: Participants]
     
Female   11   9   20 
Male   8   9   17 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Excreting Resistant Virus   [ Time Frame: Day 5 ]

2.  Secondary:   Percentage of Participants With A Reduction in Viral Load   [ Time Frame: Baseline, Day 5 ]

3.  Secondary:   Number of Participants With Various Clinical Signs and Symptoms   [ Time Frame: Day 5 ]

4.  Secondary:   Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected   [ Time Frame: Day 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00949533     History of Changes
Other Study ID Numbers: ML22789
First Submitted: July 15, 2009
First Posted: July 30, 2009
Results First Submitted: April 29, 2016
Results First Posted: August 8, 2016
Last Update Posted: August 8, 2016