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

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.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Influenza
Interventions Drug: Oseltamivir
Drug: Placebo
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
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
Reason Not Completed
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.
Arm/Group Title Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 26 26 25 24 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 25 participants 24 participants 101 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
[1]
Measure Description: Overall number of baseline participants is based on the Intent-to-Treat population.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 25 participants 24 participants 101 participants
Female
13
  50.0%
15
  57.7%
14
  56.0%
12
  50.0%
54
  53.5%
Male
13
  50.0%
11
  42.3%
11
  44.0%
12
  50.0%
47
  46.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 25 participants 24 participants 101 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.Primary Outcome
Title Time to Cessation of Viral Shedding
Hide Description 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.
Time Frame Day 1 to Day 40
Hide Outcome Measure Data
Hide Analysis Population Description
ITT infected (ITTI) Population, including all patients randomized who received at least one dose of study medication with laboratory confirmation of pandemic (H1N1) 2009 influenza infection, excluding patients infected with oseltamivir-resistant influenza A H1N1 H275Y at baseline and patients not shedding virus at baseline.
Arm/Group Title Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 19 18 16 17
Median (95% Confidence Interval)
Unit of Measure: hours
65.6
(47.5 to 79.9)
70.8
(62.1 to 101.7)
58.1
(27.3 to 93.3)
74.1
(48.6 to 117.5)
2.Secondary Outcome
Title Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture
Hide Description Viral shedding was measured by viral culture from samples obtained from nasal and throat swabs and performed by the central laboratory.
Time Frame Baseline and Days 3, 6, 8, 11, 15 and 40
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI
Arm/Group Title Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 19 18 16 17
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n=19, 18, 16, 17) 100 100 100 100
Day 3 (n=19, 17, 15, 15) 37 61 44 53
Day 6 (n=19, 17, 15, 15) 0 0 6 12
Day 8 (n=18, 17, 15, 15) 5 0 0 6
Day 11 (n=18, 18, 15, 14) 5 11 0 0
Day 15 (n=18, 14, 15, 12) 0 0 0 0
Day 40 (n=16, 15, 16, 14) 5 11 0 12
3.Secondary Outcome
Title Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction
Hide Description 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.
Time Frame Baseline and Days 3, 6, 8, 11, 15 and 40
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI
Arm/Group Title Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 19 18 16 17
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n=19, 18, 16, 17) 89 100 100 100
Day 3 (n=19, 17, 15, 15) 79 83 69 76
Day 6 (n=19, 17, 16, 15) 26 28 50 47
Day 8 (n=18, 17, 15, 15) 11 11 13 12
Day 11 (n=18, 18, 15, 14) 5 6 25 18
Day 15 (n=18, 14, 15, 12) 0 6 0 6
Day 40 (n=16, 15, 16, 14) 5 6 6 0
4.Secondary Outcome
Title Change From Baseline in Influenza Titer Measured by Viral Culture
Hide Description 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).
Time Frame Baseline, Days 2 through 15
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI
Arm/Group Title Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 19 18 16 17
Mean (Standard Deviation)
Unit of Measure: Log10 TCID50
Baseline (n=19, 18, 16, 17) 3.74  (1.478) 4.06  (1.235) 4.14  (1.338) 4.54  (0.746)
Day 2 (n=19, 18, 15, 17) -1.82  (1.457) -1.17  (1.138) -1.97  (1.584) -1.15  (1.425)
Day 3 (n=19, 18, 15, 17) -2.38  (1.670) -2.18  (1.221) -2.95  (1.286) -2.88  (1.296)
Day 4 (n=19, 18, 15, 17) -3.18  (1.511) -3.29  (1.129) -3.33  (1.368) -3.76  (0.859)
Day 5 (n=19, 18, 16, 17) -3.00  (1.656) -3.43  (1.140) -3.45  (1.453) -3.91  (0.765)
Day 6 (n=19, 18, 15, 17) -3.22  (1.488) -3.56  (1.235) -3.45  (1.530) -3.99  (0.726)
Day 7 (n=19, 18, 16, 17) -3.22  (1.469) -3.53  (1.218) -3.58  (1.331) -4.04  (0.746)
Day 8 (n=19, 18, 15, 17) -3.18  (1.457) -3.56  (1.235) -3.65  (1.385) -4.04  (0.746)
Day 9 (n=19, 18, 14, 16) -3.24  (1.478) -3.53  (1.218) -3.57  (1.381) -4.08  (0.688)
Day 10 (n=19, 18, 15, 16) -3.21  (1.463) -3.50  (1.260) -3.55  (1.334) -4.14  (0.652)
Day 11 (n=19, 16, 16, 15) -3.22  (1.469) -3.42  (1.524) -3.64  (1.338) -4.08  (0.632)
Day 12 (n=19, 18, 15, 15) -3.11  (1.669) -3.47  (1.289) -3.63  (1.385) -4.10  (0.653)
Day 13 (n=19, 18, 16, 15) -3.17  (1.458) -3.43  (1.248) -3.64  (1.338) -4.10  (0.653)
Day 14 (n=18, 18, 15, 15) -3.17  (1.488) -3.56  (1.235) -3.55  (1.334) -4.10  (0.653)
Day 15 (n=18, 17, 14, 15) -3.14  (1.456) -3.50  (1.250) -3.55  (1.401) -4.10  (0.653)
5.Secondary Outcome
Title Number of Participants With Development of Oseltamivir-Resistant Influenza Virus
Hide Description 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 Frame 40 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI Population
Arm/Group Title Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 19 18 16 17
Measure Type: Number
Unit of Measure: participants
0 1 1 0
6.Secondary Outcome
Title Time to Resolution of Fever
Hide Description 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 Frame Day 1 through Day 40
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population with fever at Baseline.
Arm/Group Title Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 10 6 8 3
Median (95% Confidence Interval)
Unit of Measure: hours
19.3
(10.6 to 58.4)
35.5
(12.7 to 53.1)
24.9
(15.7 to 45.2)
20.0
(15.9 to 74.3)
7.Secondary Outcome
Title Time to Alleviation of All Clinical Symptoms - Children
Hide Description 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 Frame Day 1 to Day 40
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population including children only (ages 1 - 12 years).
Arm/Group Title Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 4 4 3
Median (95% Confidence Interval)
Unit of Measure: hours
176.8
(67.5 to 302.0)
127.7
(32.6 to 281.8)
118.8
(46.3 to 228.2)
123.1
(7.1 to 232.3)
8.Secondary Outcome
Title Time to Alleviation of All Clinical Symptoms - Adults
Hide Description 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.
Time Frame Day 1 to Day 40
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population including adults only (>12 years old).
Arm/Group Title Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 13 14 12 14
Median (95% Confidence Interval)
Unit of Measure: hours
140.0
(99.8 to 183.1)
181.8
(87.0 to 354.6)
146.8
(109.1 to 237.8)
94.9
(57.2 to 261.2)
9.Secondary Outcome
Title Number of Participants Who Developed Secondary Illnesses During the Study
Hide Description 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.
Time Frame Day 1 through Day 40
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population
Arm/Group Title Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 19 18 16 17
Measure Type: Number
Unit of Measure: participants
Bronchitis 1 0 0 0
Otitis media 0 0 0 0
Pneumonia 0 0 0 0
Sinusitis 0 0 0 2
Any secondary illness 1 0 0 2
10.Secondary Outcome
Title Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics
Hide Description 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.
Time Frame Day 1 through Day 40
Hide Outcome Measure Data
Hide Analysis Population Description
ITTI population
Arm/Group Title Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 19 18 16 17
Measure Type: Number
Unit of Measure: participants
0 0 0 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/26 (0.00%)   0/25 (0.00%)   0/24 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oseltamivir Standard Dose 5 Days Oseltamivir Standard Dose 10 Days Oseltamivir High Dose 5 Days Oseltamivir High Dose 10 Days
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/26 (11.54%)   5/26 (19.23%)   3/25 (12.00%)   6/24 (25.00%) 
Gastrointestinal disorders         
Vomiting  1  0/26 (0.00%)  2/26 (7.69%)  0/25 (0.00%)  6/24 (25.00%) 
Nausea  1  1/26 (3.85%)  1/26 (3.85%)  1/25 (4.00%)  2/24 (8.33%) 
Infections and infestations         
Upper respiratory tract infection  1  1/26 (3.85%)  2/26 (7.69%)  0/25 (0.00%)  0/24 (0.00%) 
Injury, poisoning and procedural complications         
Accidental overdose  1  0/26 (0.00%)  0/26 (0.00%)  2/25 (8.00%)  2/24 (8.33%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  2/26 (7.69%)  0/26 (0.00%)  0/25 (0.00%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01032837    
Other Study ID Numbers: NV22155
First Submitted: December 10, 2009
First Posted: December 16, 2009
Results First Submitted: July 12, 2012
Results First Posted: August 20, 2012
Last Update Posted: October 2, 2012