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The primary objective of this study is to confirm the efficacy of CS-8958 administered as a single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir phosphate using the time to alleviation of influenza illness. For safety evaluation, between-group comparisons will be made with regard to incidence of adverse events and other safety measures.
In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS-8958 Low Dose | Experimental | CS-8958 powder to be inhaled - low-dose arm |
|
| CS-8958 High Dose | Experimental | CS-8958 powder to be inhaled - high-dose arm |
|
| Oseltamivir phosphate | Active Comparator | oseltamivir phosphate oral capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS-8958 | Drug | CS-8958 powder 20 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Alleviation of Influenza Illness | The time to illness alleviation which was defined as the time from the initiation of trial treatment to the beginning of the first 21.5-h period in which all influenza symptoms were "absent" or "mild." Patients recorded their severity of influenza symptoms (headache, myalgia/arthralgia, fatigue, chills/sweats, nasal symptom, sore throat, and cough) 4 times daily for 15 days. Patients whose influenza symptoms had not been alleviated at the time of their withdrawal from the study or at the end of the observation period were censored. | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time for Body Temperature to Return to Normal | Time for return to normal axillary temperature was was defined as the time until the beginning of the first 21.5-hour period in which the axillary temperature returned to 36.9°C. Patients recorded their axillary temperature 4 times daily for 15 days. Patients whose axillary temperature had not been returned to 36.9°C at the time of their withdrawal from the study or at the end of the observation period were censored. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong | China | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20936975 | Derived | Watanabe A, Chang SC, Kim MJ, Chu DW, Ohashi Y; MARVEL Study Group. Long-acting neuraminidase inhibitor laninamivir octanoate versus oseltamivir for treatment of influenza: A double-blind, randomized, noninferiority clinical trial. Clin Infect Dis. 2010 Nov 15;51(10):1167-75. doi: 10.1086/656802. Epub 2010 Oct 11. |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Full analysis set (FAS) was defined as the set of subjects who had a positive test result using the influenza rapid diagnostic kit, received at least 1 dose of the study drug, and had valid efficacy data. The data for the baseline characteristics is provided for this analysis set, not for all participants who entered the trial.
This multicenter, double-blind,randomized, active-controlled trial was conducted from November 2008 through March 2009 at 117 institutions in Japan, Taiwan, Korea, and China (Hong Kong).
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| ID | Title | Description |
|---|---|---|
| FG000 | CS-8958 High Dose 40 mg | CS-8958 powder to be inhaled - high-dose arm |
| FG001 | CS-8958 Low Dose 20 mg | CS-8958 powder to be inhaled - low-dose arm |
| FG002 | Oseltamivir 75 mg | oseltamivir phosphate oral capsules |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CS-8958 High Dose 40 mg | CS-8958 powder to be inhaled - high-dose arm |
| BG001 | CS-8958 Low Dose 20 mg | CS-8958 powder to be inhaled - low-dose arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Alleviation of Influenza Illness | The time to illness alleviation which was defined as the time from the initiation of trial treatment to the beginning of the first 21.5-h period in which all influenza symptoms were "absent" or "mild." Patients recorded their severity of influenza symptoms (headache, myalgia/arthralgia, fatigue, chills/sweats, nasal symptom, sore throat, and cough) 4 times daily for 15 days. Patients whose influenza symptoms had not been alleviated at the time of their withdrawal from the study or at the end of the observation period were censored. | Full analysis set (FAS) was defined as the set of subjects who had a positive test result using the influenza rapid diagnostic kit, received at least 1 dose of the study drug, and had valid efficacy data. | Posted | Median | 95% Confidence Interval | hours | 15 days |
|
15 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CS-8958 High Dose 40 mg | CS-8958 powder to be inhaled - high-dose arm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA Japan (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Japan (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Kessler | Daiichi Sankyo Pharma Development | 732-590-5032 | hmkessler@dsi.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C546919 | CS 8958 |
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| CS-8958 | Drug | CS-8958 powder 40 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days |
|
| oseltamivir phosphate | Drug | CS-8958 placebo powder to be inhaled one time. Oseltamivir phosphate oral capsules taken twice daily for 5 days. |
|
| 15 days |
| Tokyo |
| Japan |
| Seoul | South Korea |
| Taipei | Taiwan |
| Withdrawal by Subject |
|
| BG002 | Oseltamivir 75 mg | oseltamivir phosphate oral capsules |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Laboratory confirmed influenza | Number | Participants |
|
| OG001 | CS-8958 Low Dose 20 mg | CS-8958 powder to be inhaled - low-dose arm |
| OG002 | Oseltamivir 75 mg | oseltamivir phosphate oral capsules |
|
|
|
| Secondary | Time for Body Temperature to Return to Normal | Time for return to normal axillary temperature was was defined as the time until the beginning of the first 21.5-hour period in which the axillary temperature returned to 36.9°C. Patients recorded their axillary temperature 4 times daily for 15 days. Patients whose axillary temperature had not been returned to 36.9°C at the time of their withdrawal from the study or at the end of the observation period were censored. | Posted | Median | 95% Confidence Interval | hours | 15 days |
|
|
|
|
| 0 |
| 337 |
| 63 |
| 337 |
| EG001 | CS-8958 Low Dose 20 mg | CS-8958 powder to be inhaled - low-dose arm | 0 | 326 | 54 | 326 |
| EG002 | Oseltamivir 75 mg | oseltamivir phosphate oral capsules | 2 | 336 | 63 | 336 |
| Wallenberg syndrome | Nervous system disorders | MedDRA Japan (12.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Japan (12.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Japan (12.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Japan (12.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Japan (12.0) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA Japan (12.0) | Systematic Assessment |
|
| Alanine aminotransferase increase | Investigations | MedDRA Japan (12.0) | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA Japan (12.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Japan (12.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Japan (12.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Japan (12.0) | Systematic Assessment |
|
Principle investigator shall not publish the results of the study at any time without the prior written approval of Sponsor.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Null hypothesis was that there was no difference in the time for return to normal axillary temperature. |
| Generalized Wilcoxon test |
| 0.981 |
2-sided P value without adjustments for multiple testing. |
| Median Difference (Final Values) |
| 0.6 |
| 2-Sided |
| 95 |
| -5.8 |
| 5.7 |
| Superiority or Other |
| Null hypothesis was that there was no difference in the time for return to normal axillary temperature. | Generalized Wilcoxon test | 0.344 | 2-sided P value without adjustments for multiple testing. | Median Difference (Final Values) | -2.7 | 2-Sided | 95 | -9.1 | 3.1 | Superiority or Other |