Trial record 4 of 6 for:
Oseltamivir | Studies With Results
A Study of Tamiflu (Oseltamivir) for the Seasonal Prophylaxis of Influenza in Immunocompromised Patients.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00412737
First received: December 15, 2006
Last updated: July 30, 2010
Last verified: July 2010
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Results First Received: August 3, 2009
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention |
| Condition: |
Influenza |
| Interventions: |
Drug: oseltamivir [Tamiflu] Drug: Placebo |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Patients were recruited from 44 centers over the period of 17 January 2007 to 3 June 2008. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Placebo | No text entered. |
| Oseltamivir 75 mg | No text entered. |
Participant Flow: Overall Study
| Placebo | Oseltamivir 75 mg | |
|---|---|---|
| STARTED | 237 [1] | 238 [1] |
| COMPLETED | 208 [2] | 220 [2] |
| NOT COMPLETED | 29 | 18 |
| [1] | No. randomized |
|---|---|
| [2] | No. included in Per Protocol analysis |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Placebo | No text entered. |
| Oseltamivir 75 mg | No text entered. |
| Total | Total of all reporting groups |
Baseline Measures
| Placebo | Oseltamivir 75 mg | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
237 | 238 | 475 |
|
Age
[units: years] Mean ± Standard Deviation |
48.9 ± 15.57 | 49.4 ± 15.47 | 49.2 ± 15.56 |
|
Gender
[units: participants] |
|||
| Female | 86 | 74 | 160 |
| Male | 151 | 164 | 315 |
|
Height
[units: cm] Mean ± Standard Deviation |
167.8 ± 14.57 | 168.7 ± 16.07 | 168.3 ± 15.33 |
|
Weight
[units: kg] Mean ± Standard Deviation |
76.42 ± 20.358 | 76.40 ± 21.269 | 76.4 ± 20.80 |
Outcome Measures
| 1. Primary: | No. of Patients With Laboratory-confirmed Clinical Influenza [ Time Frame: 12 weeks ] |
| Measure Type | Primary |
|---|---|
| Measure Title | No. of Patients With Laboratory-confirmed Clinical Influenza |
| Measure Description | No text entered. |
| Time Frame | 12 weeks |
| Safety Issue | No |
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. |
|---|
| intent-to-treat (ITT) population |
Reporting Groups
| Description | |
|---|---|
| Placebo | No text entered. |
| Oseltamivir 75 mg | No text entered. |
Measured Values
| Placebo | Oseltamivir 75 mg | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
238 | 237 |
|
No. of Patients With Laboratory-confirmed Clinical Influenza
[units: participants] |
||
| Number | 7 | 5 |
No statistical analysis provided for No. of Patients With Laboratory-confirmed Clinical Influenza
| 2. Secondary: | No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture [ Time Frame: 12 weeks ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture |
| Measure Description | No text entered. |
| Time Frame | 12 weeks |
| Safety Issue | No |
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. |
|---|
| per protocol population |
Reporting Groups
| Description | |
|---|---|
| Placebo | No text entered. |
| Oseltamivir 75 mg | No text entered. |
Measured Values
| Placebo | Oseltamivir 75 mg | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
208 | 220 |
|
No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture
[units: participants] |
6 | 4 |
No statistical analysis provided for No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture
| 3. Secondary: | No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture [ Time Frame: 12 weeks ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture |
| Measure Description | No text entered. |
| Time Frame | 12 weeks |
| Safety Issue | No |
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. |
|---|
| Intent-to-treat Virus Negative at Baseline population (ITTNAB) |
Reporting Groups
| Description | |
|---|---|
| Placebo | No text entered. |
| Oseltamivir 75 mg | No text entered. |
Measured Values
| Placebo | Oseltamivir 75 mg | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
231 | 232 |
|
No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture
[units: participants] |
7 | 4 |
No statistical analysis provided for No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture
| 4. Secondary: | No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) [ Time Frame: 12 weeks ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) |
| Measure Description | No text entered. |
| Time Frame | 12 weeks |
| Safety Issue | No |
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. |
|---|
| intent-to-treat (ITT) population |
Reporting Groups
| Description | |
|---|---|
| Placebo | No text entered. |
| Oseltamivir 75 mg | No text entered. |
Measured Values
| Placebo | Oseltamivir 75 mg | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
238 | 237 |
|
No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
[units: participants] |
7 | 2 |
No statistical analysis provided for No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
| 5. Secondary: | No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) [ Time Frame: 12 weeks ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) |
| Measure Description | No text entered. |
| Time Frame | 12 weeks |
| Safety Issue | No |
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. |
|---|
| Intent-to-treat Virus Negative at Baseline population (ITTNAB) |
Reporting Groups
| Description | |
|---|---|
| Placebo | No text entered. |
| Oseltamivir 75 mg | No text entered. |
Measured Values
| Placebo | Oseltamivir 75 mg | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
231 | 232 |
|
No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
[units: participants] |
7 | 1 |
No statistical analysis provided for No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
| 6. Secondary: | No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) [ Time Frame: 12 weeks ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) |
| Measure Description | No text entered. |
| Time Frame | 12 weeks |
| Safety Issue | No |
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. |
|---|
| intent-to-treat (ITT) population |
Reporting Groups
| Description | |
|---|---|
| Placebo | No text entered. |
| Oseltamivir 75 mg | No text entered. |
Measured Values
| Placebo | Oseltamivir 75 mg | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
238 | 237 |
|
No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
[units: participants] |
8 | 5 |
No statistical analysis provided for No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
| 7. Secondary: | No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) [ Time Frame: 12 weeks ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) |
| Measure Description | No text entered. |
| Time Frame | 12 weeks |
| Safety Issue | No |
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. |
|---|
| Intent-to-treat Virus Negative at Baseline population (ITTNAB) |
Reporting Groups
| Description | |
|---|---|
| Placebo | No text entered. |
| Oseltamivir 75 mg | No text entered. |
Measured Values
| Placebo | Oseltamivir 75 mg | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
231 | 232 |
|
No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
[units: participants] |
8 | 4 |
No statistical analysis provided for No. of Patients With Laboratory Confirmed Clinical Influenza Confirmed by Serology/Viral Culture or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided by Hoffmann-La Roche
Publications automatically indexed to this study:
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT 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. |
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 |
|---|
| There were no overall limitations and caveats. |
Results Point of Contact:
Name/Title: Medical Communications Specialist
Organization: Hoffmann-La Roche
phone: 800-821-8590
Organization: Hoffmann-La Roche
phone: 800-821-8590
No publications provided by Hoffmann-La Roche
Publications automatically indexed to this study:
| Responsible Party: | Clinical Trials, Study Director, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00412737 History of Changes |
| Other Study ID Numbers: | NV20235 |
| Study First Received: | December 15, 2006 |
| Results First Received: | August 3, 2009 |
| Last Updated: | July 30, 2010 |
| Health Authority: | United States: Food and Drug Administration |