Clinical Trial Results:
A randomized, multicenter trial of oseltamivir doses of 75 mg for 5 or 10 days versus 150 mg for 5 or 10 days in influenza patients with pandemic (H1N1) 2009
Summary
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EudraCT number |
2016-001008-49 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
28 Jun 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Mar 2017
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First version publication date |
07 Mar 2017
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
NV22155
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01032837 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
F. Hoffmann-La Roche Ltd
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Sponsor organisation address |
Grenzacherstrasse 124, Basel, Switzerland, CH-4070
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Public contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
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Scientific contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Jun 2010
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Jun 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To prospectively evaluate the efficacy of four regimens of oseltamivir on the duration of viral shedding in patients infected with pandemic (H1N1) 2009.
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Protection of trial subjects |
The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. A Data Review committee (DRC) supervised the participants’ safety and performed the pre-specified interim analyses according to the protocol. Before entering the study, the informed consent form was read by and explained to all participants and/or their legally authorized representative. Participants signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Nov 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 101
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Worldwide total number of subjects |
101
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
4
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Children (2-11 years) |
21
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Adolescents (12-17 years) |
11
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Adults (18-64 years) |
65
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted at 27 centers in the United States (US). In all, 102 participants were enrolled in this study and 101 received the study medication | ||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Overall, 574 participants were screened during the study; 102 were randomized to receive study treatment and one patient withdrew consent prior to first dose. There were 472 screen failures and the main reason for screen failures were a result of a negative rapid influenza test. | ||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Oseltamivir Standard Dose 5 Days | ||||||||||||||||||||||||||||||||||||||||
Arm 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. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Oseltamivir
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Investigational medicinal product code |
Ro 64-0796
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Adults and children 13 years and older received 75mg oral capsule two times a day for five days.
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Investigational medicinal product name |
Oseltamivir
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Investigational medicinal product code |
Ro 64-0796
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Other name |
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Pharmaceutical forms |
Powder for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension orally twice daily for five days.
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Adults and children 13 years and older received 75 mg matching oral placebo capsule twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) matching placebo suspension orally twice daily for five days. Participants received matching placebo for the second 5 days of treatment.
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Arm title
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Oseltamivir Standard Dose 10 Days | ||||||||||||||||||||||||||||||||||||||||
Arm description |
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. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Oseltamivir
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Investigational medicinal product code |
Ro 64-0796
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Adults and children 13 years and older received 75mg oral capsule two times a day for ten days.
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Investigational medicinal product name |
Oseltamivir
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Investigational medicinal product code |
Ro 64-0796
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Other name |
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Pharmaceutical forms |
Powder for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension orally twice daily for ten days.
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Adults and children 13 years and older received 75 mg matching oral placebo capsule twice daily for 10 days.
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) matching placebo suspension orally twice daily for ten days.
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Arm title
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Oseltamivir High Dose 5 Days | ||||||||||||||||||||||||||||||||||||||||
Arm description |
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. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Oseltamivir
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Investigational medicinal product code |
Ro 64-0796
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir oral capsule two times a day for five days.
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Investigational medicinal product name |
Oseltamivir
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Investigational medicinal product code |
Ro 64-0796
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Other name |
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Pharmaceutical forms |
Powder for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for five days.
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received matching placebo for the second 5 days of treatment.
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received matching placebo for the second 5 days of treatment.
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Arm title
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Oseltamivir High Dose 10 Days | ||||||||||||||||||||||||||||||||||||||||
Arm description |
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 | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Oseltamivir
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Investigational medicinal product code |
Ro 64-0796
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days.
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Investigational medicinal product name |
Oseltamivir
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Investigational medicinal product code |
Ro 64-0796
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Other name |
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Pharmaceutical forms |
Powder for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
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Baseline characteristics reporting groups
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Reporting group title |
Oseltamivir Standard Dose 5 Days
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Reporting 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Oseltamivir Standard Dose 10 Days
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Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Oseltamivir High Dose 5 Days
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Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Oseltamivir High Dose 10 Days
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Reporting group description |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Oseltamivir Standard Dose 5 Days
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Reporting 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. | ||
Reporting group title |
Oseltamivir Standard Dose 10 Days
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Reporting group description |
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. | ||
Reporting group title |
Oseltamivir High Dose 5 Days
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Reporting group description |
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. | ||
Reporting group title |
Oseltamivir High Dose 10 Days
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Reporting group description |
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 |
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End point title |
Time to Cessation of Viral Shedding [1] | |||||||||||||||||||||||||
End point 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.
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End point type |
Primary
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End point timeframe |
Day 1 to Day 40
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Study data were analyzed by descriptive summaries. No formal hypothesis testing was planned. |
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No statistical analyses for this end point |
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End point title |
Number of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture | ||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Viral shedding was measured by viral culture from samples obtained from nasal and throat swabs and performed by the central laboratory. Only the numbers of participants available at the particular time point were included in the analysis.
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End point type |
Secondary
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End point timeframe |
Baseline and Days 3, 6, 8, 11, 15 and 40
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No statistical analyses for this end point |
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End point title |
Number of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction | ||||||||||||||||||||||||||||||||||||||||||||||||||
End point 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. Only the numbers of participants available at the particular time point were included in the analysis.
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End point type |
Secondary
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End point timeframe |
Baseline and Days 3, 6, 8, 11, 15 and 40
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Influenza Titer Measured by Viral Culture | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point 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).
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End point type |
Secondary
|
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End point timeframe |
Baseline, Days 2 through 15
|
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No statistical analyses for this end point |
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End point title |
Number of Participants With Development of Oseltamivir-Resistant Influenza Virus | ||||||||||||||||||||
End point 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.
|
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End point type |
Secondary
|
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End point timeframe |
40 Days
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No statistical analyses for this end point |
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End point title |
Time to Resolution of Fever | |||||||||||||||||||||||||
End point 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.
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End point type |
Secondary
|
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End point timeframe |
Day 1 through Day 40
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No statistical analyses for this end point |
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End point title |
Time to Alleviation of All Clinical Symptoms - Children | |||||||||||||||||||||||||
End point 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.
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End point type |
Secondary
|
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End point timeframe |
Day 1 to Day 40
|
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No statistical analyses for this end point |
|
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End point title |
Time to Alleviation of All Clinical Symptoms - Adults | |||||||||||||||||||||||||
End point 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.
|
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End point type |
Secondary
|
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End point timeframe |
Day 1 to Day 40
|
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No statistical analyses for this end point |
|
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End point title |
Number of Participants Who Developed Secondary Illnesses During the Study | ||||||||||||||||||||||||||||||||||||||||
End point 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.
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End point type |
Secondary
|
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End point timeframe |
Day 1 through Day 40
|
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No statistical analyses for this end point |
|
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End point title |
Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics | |||||||||||||||
End point 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.
|
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End point type |
Secondary
|
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End point timeframe |
Day 1 through Day 40
|
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|
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No statistical analyses for this end point |
|
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End point title |
Number of Participants with any Adverse Event (AE) or Serious Adverse Event (SAE) | |||||||||||||||||||||||||||||||||||
End point description |
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly.
|
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End point type |
Secondary
|
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End point timeframe |
Up to 1 year
|
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|
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No statistical analyses for this end point |
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Adverse events information
|
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Timeframe for reporting adverse events |
Up to Day 40
|
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.1
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Reporting groups
|
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Reporting group title |
Oseltamivir Standard Dose 5 Days
|
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Reporting 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Oseltamivir Standard Dose 10 Days
|
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Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Oseltamivir High Dose 5 Days
|
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Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Oseltamivir High Dose 10 Days
|
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Reporting group description |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
30 Oct 2009 |
This protocol amendment included addition of the exclusion criterion for vaccination with live attenuated influenza vaccine and Inclusion of patients with influenza A without further specification of pandemic influenza A (H1N1) 2009 |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |