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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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This study has been designed to determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention / working memory / processing speed / mood as compared to subjects receiving standard of care alone. The cognitive tests employed are objective measures developed and administered online by HeadMinder Inc.
Primary Objective:
To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention as compared to subjects receiving standard of care alone.
Secondary Objectives:
To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in working memory and processing speed as compared to subjects receiving standard of care alone.
Supportive Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oseltamivir | Active Comparator | Added to standard of care for influenza |
|
| Standard of care alone | No Intervention | Standard of care for influenza |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir | Drug | Oseltamivir 75mg BID for 5 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Attention Assessment | Attention assessed using simple reaction time measured in milliseconds. Simple reaction time calculated as the mean of the following 2 sub-tests:
The lower the value, the better the attention. | Change from baseline at Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Working Memory Assessment | Working memory assessed with the Dot Memory Test. The higher the value, the better the working memory. | Change from baseline at Day 4 |
| Change in Processing Speed Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mood Assessment | Mood was assessed using the Bond-Lader 10 cm (100 mm) visual analogue scales for mood (16 scales in total); factored for alertness (mean of 9 scales), calmness (mean of 2 scales) and contentment (mean of 5 scales). The range in score for each scale and for each factor (alertness, calmness and contentment) was 0 - 100 mm. Each scale was anchored such that the lower the value, the better the mood. |
Inclusion Criteria:
Adult men and women, 18 - 65 years of age (inclusive)
Indicative symptoms/signs of uncomplicated acute illness due to influenza infection (A or B strains) that started within a maximum of 2 days prior to Visit 1 as per the Tamiflu® Canadian product label. Signs and symptoms may include the following:
Positive rapid antigen test for influenza (A or B strains) at Visit 1
Negative urine pregnancy test at Visit 1 for women of childbearing potential; women of childbearing potential who are sexually active must agree to use a suitable form of contraception during the study. Acceptable birth control measures include: hysterectomy, birth control pills, tubal ligation, intrauterine device, hormonal injections and implants, double barrier methods (such as a condom with a diaphragm or a condom with spermicide), and abstinence. Oral contraceptives must be in stable use for 2 or more cycles prior to screening. Intrauterine device (IUD) must be in use at least 30 days prior to study drug administration. Barrier methods must be in use at least 14 days prior to study drug administration.
Subjects must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. O'Mahony, M.D. | London Road Diagnostic Clinic and Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Collette | Vancouver | British Columbia | Canada | |||
| Dr. Lai |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oseltamivir | Added to standard of care for influenza Oseltamivir: Oseltamivir 75mg BID for 5 days |
| FG001 | Standard of Care Alone | Standard of care for influenza |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oseltamivir | Added to standard of care for influenza Oseltamivir: Oseltamivir 75mg BID for 5 days |
| BG001 | Standard of Care Alone | Standard of care for influenza |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Change in Attention Assessment | Attention assessed using simple reaction time measured in milliseconds. Simple reaction time calculated as the mean of the following 2 sub-tests:
The lower the value, the better the attention. | All randomised subjects for whom data was collected at both baseline and Day 4. Oseltamivir group: baseline data available for 58 of 59 randomised subjects and Day 4 data for 53 subjects (53 subjects analysed). Standard of Care Alone group: baseline data available for 61 of 63 subjects and Day 4 data for 55 subjects (55 subjects analysed). | Posted | Least Squares Mean | Standard Error | milliseconds | Change from baseline at Day 4 |
|
14 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 | Oseltamivir | Added to standard of care for influenza Oseltamivir: Oseltamivir 75mg BID for 5 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joanne Morris, Clinical Research Quality Manager | Trial Management Group Inc. | 4169297717 | joanne@tmginvestigators.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 |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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Open Label
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Processing speed assessed with the animal number decoding subtest
The lower the value, the better the processing speed
| Change from baseline at Day 4 |
| Change from baseline at Day 4 |
| Vancouver |
| British Columbia |
| Canada |
| Topsail Road Medical Clinic | St. John's | Newfoundland and Labrador | Canada |
| Moran Medical Centre | Collingwood | Ontario | Canada |
| Dr. Kanani | Etobicoke | Ontario | Canada |
| Dr. Herman | London | Ontario | Canada |
| Milestone Research | London | Ontario | Canada |
| SKDS Research Inc | Newmarket | Ontario | Canada |
| Family First Medical Centre | Orléans | Ontario | Canada |
| Steeple Hill Medical Centre | Pickering | Ontario | L1V 2A6 | Canada |
| Dr. Martyn Chilvers - London Road Diagnostic Clinic and Medical Centre | Sarnia | Ontario | Canada |
| Dr. Michael O'Mahony - London Road Diagnostic Clinic and Medical Centre | Sarnia | Ontario | Canada |
| DCTM Clinical Trials Group Ltd. | Strathroy | Ontario | Canada |
| Dr. Gupta | Toronto | Ontario | Canada |
| Devonshire Clinical Research Inc. | Woodstock | Ontario | Canada |
| Regina Medical Centre | Regina | Saskatchewan | S4P 3X1 | Canada |
| BG002 | 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 |
|
| Highest Education Level | Count of Participants | Participants |
|
| Current Smoker | Count of Participants | Participants |
|
| Time from Symptom Onset | Data was not collected for 1 patient in each group in error | Median | Full Range | hours |
|
| Baseline Symptom Score | Participants recorded the severity of 7 influenza symptoms (cough, nasal obstruction, sore throat, fatigue, headache, myalgia, and feverishness) using a 4-point scale (0, absent; 3, severe) each day for 14 days. Symptom severity was assessed by summing the severity rating (0-3) for the seven symptoms at each day. | Median | Full Range | symptom score |
|
| Body Temperature | Median | Full Range | Degrees centigrade |
|
| Health Assessment Question | Subjects rated their general health status each day using an 11-point VAS (0 = worst possible health; 10 = normal health for someone your age). | Median | Full Range | Score |
|
| Influenza Type | Assessed through Rapid Antigen Test | Count of Participants | Participants |
|
| Cognitive/Mood Conditions | Count of Participants | Participants |
|
| OG001 |
| Standard of Care Alone |
Standard of care for influenza |
|
|
|
| Secondary | Change in Working Memory Assessment | Working memory assessed with the Dot Memory Test. The higher the value, the better the working memory. | All randomised subjects with data collected at both Baseline and Day 4. Oseltamivir Group: Baseline values collected for all randomized subjects (59); Day 4 data available for 54 subjects (54 analysed). Standard of Care Alone Group: Baseline values collected for all randomized subjects (63); Day 4 data available for 58 subjects (58 analysed) | Posted | Least Squares Mean | Standard Error | Number of correct answers | Change from baseline at Day 4 |
|
|
|
|
| Secondary | Change in Processing Speed Assessment | Processing speed assessed with the animal number decoding subtest The lower the value, the better the processing speed | All randomized subjects for whom data was collected at both Baseline and Day 4. Oseltamivr Group: Baseline data available for all randomized subjects (59); Day 4 data available for 54 subjects (54 analysed). Standard of Care Alone Group: Baseline data available for all randomized subjects (63); Day 4 data available for 58 subjects (58 analysed). | Posted | Least Squares Mean | Standard Error | Millliseconds | Change from baseline at Day 4 |
|
|
|
|
| Other Pre-specified | Change in Mood Assessment | Mood was assessed using the Bond-Lader 10 cm (100 mm) visual analogue scales for mood (16 scales in total); factored for alertness (mean of 9 scales), calmness (mean of 2 scales) and contentment (mean of 5 scales). The range in score for each scale and for each factor (alertness, calmness and contentment) was 0 - 100 mm. Each scale was anchored such that the lower the value, the better the mood. | All randomised subjects with data collected at both Baseline and Day 4. Baseline data was available for all randomized subjects in both groups; Day 4 data was available for 54 of 59 randomized subjects in the Oseltamivir Group (54 analysed) and for 58 of 63 randomized subjects in the Standard of Care Alone Group (58 analysed). | Posted | Least Squares Mean | Standard Error | millimeter | Change from baseline at Day 4 |
|
|
|
|
| 0 |
| 59 |
| 8 |
| 59 |
| EG001 | Standard of Care Alone | Standard of care for influenza | 0 | 63 | 8 | 63 |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Anxiety Disorder | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Anger | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
If Sponsor has not submitted a manuscript for publication for this multi-center study within 12 months of study completion/termination, the PI will be free to publish separately. Sponsor can review results communications prior to public release and can embargo communications for up to 90 days if the proposed publication contains information relating to patentable items. If Sponsor believes proposed communications contain any confidential information, Sponsor has the right to remove it.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 - 3 Years College |
|
| Bachelor's Degree |
|
| Post-Graduate |
|
| Anxiety |
|
| Depression |
|
| Change in Contentedness Assessment |
|
Calmness: the higher the value, the greater the calmness.
| ANCOVA |
| .7219 |
| LS Means Difference |
| -.6 |
| 2-Sided |
| 95 |
| -4.1 |
| 2.9 |
The LS means for Standard of Care AL one was subtracted from that of Oseltamivir. |
| Superiority or Other |
| Contentedness: the higher the value, the greater the contentedness. | ANCOVA | .1162 | LS Means Difference | 3.3 | 2-Sided | 95 | -.8 | 7.4 | The LS means of Standard of Care Alone was subtracted from that of Oseltamivir. | Superiority or Other |