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CompletedNCT01249833FOCUSUpdated Mar 9, 2017Results posted

Effect of Oseltamivir on Cognitive Function in Subjects With Influenza

A Phase 4 interventional study of Oseltamivir in Influenza, sponsored by Trial Management Group Inc.. Completed at 16 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-09.

Sponsored by Trial Management Group Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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:

  1. To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in self-rated alertness as compared to subjects receiving standard of care alone.
  2. To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in self-rated calmness and contentment as compared to subjects receiving standard of care alone.
  3. To determine if there is a correlation between the rate of improvement in symptom scores and the rate of change in attention and working memory.
02

Conditions studied

  • Influenza

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Keywords

  • Influenza
  • Cognition
  • Attention
  • Simple Reaction Time
  • Alertness
  • Calmness
  • Contentment
  • Mood
03

In context

Influenza, Human

2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.

This study's enrollment of 122 is below the median of 240 across 1,894 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Trial Management Group Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult men and women, 18 - 65 years of age (inclusive)

  2. 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:

    • Fever
    • Respiratory symptoms (cough, coryza, sore throat, rhinitis)
    • Constitutional symptoms (headache, malaise, myalgia, sweats and/or chills, fatigue)
  3. Positive rapid antigen test for influenza (A or B strains) at Visit 1
  4. 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.

  5. Subjects must:

    • have daily access to a computer at home with: internet access (preferably high-speed for optimal performance but dial-up can be used as well); Microsoft operating system; Internet Explorer browser capability and an e-mail account. A Macintosh (Mac) computer cannot be used.
    • be capable of and willing to complete the required online assessments in English according to the protocol schedule
    • be willing to abstain from the use of an antiviral medication if they are randomised to the standard of care treatment arm
    • have provided written informed consent prior to the initiation of any study procedures

Exclusion criteria

Exclusion Criteria:

  1. More than 2 days since the onset of influenza symptoms
  2. Subjects who, in the Investigator's judgment, require treatment with an antiviral medication as per the Canadian "Clinical Recommendations for Patients Presenting with Respiratory Symptoms During the 2009 - 2010 Influenza Season" (see Appendix D)
  3. Clinical suspicion of infection with a respiratory virus other than influenza
  4. Any medical condition that is sufficiently severe or unstable such that the subject is considered to be at imminent risk of requiring hospitalisation
  5. History of conditions that may potentially affect cognitive function during the study, such as underlying neurologic conditions, depression or depressive disorders (unless the condition and treatment have been stable for 3 months), seasonal affective disorder (SAD), or any other cognitive impairment or dementia
  6. Intermittent use of sedative-hypnotics; subjects who have been taking a fixed dose of a sedative-hypnotic every day for a period of at least 30 days may be included provided that they continue the same regimen throughout the study.
  7. Intermittent or chronic use of psychiatric medications (with the exception of antidepressants that have been stable for 3 months) or anti-epileptic drugs
  8. Nursing home residents
  9. Known allergy to oseltamivir phosphate or any of the inactive ingredients of Tamiflu®
  10. Women who are pregnant, or planning to become pregnant, or who are lactating
  11. Current alcohol or drug abuse or substance dependence
  12. Participation in another clinical trial with an investigational drug within the last 30 days
  13. Patients vaccinated for influenza within 6 months of study enrollment
  14. In the Investigator's judgment, the subject will not be able to adhere to the protocol requirements or is not suitable for study participation for any reason
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
122 participants (actual)

Study arms

  • Active comparator
    Oseltamivir

    Added to standard of care for influenza

    Drug: Oseltamivir

  • No intervention
    Standard of care alone

    Standard of care for influenza

Interventions

  • DrugOseltamivir

    Oseltamivir 75mg BID for 5 days

    Also known as: Tamiflu

06

What researchers measure

Primary outcomes

  1. 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: * Reaction Time Subtest * Cued Reaction Time Subtest The lower the value, the better the attention.

    Time frame: Change from baseline at Day 4

Secondary outcomes

  1. Change in Working Memory Assessment

    Working memory assessed with the Dot Memory Test. The higher the value, the better the working memory.

    Time frame: Change from baseline at Day 4

  2. Change in Processing Speed Assessment

    Processing speed assessed with the animal number decoding subtest The lower the value, the better the processing speed

    Time frame: Change from baseline at Day 4

Other outcomes

  1. 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.

    Time frame: Change from baseline at Day 4

07

Results

Posted Mar 9, 2017

Participant flow

Participant flow — Overall Study
MilestoneOseltamivirStandard of Care Alone
Started5963
Completed5962
Not completed01
Withdrew: Lost to follow-up01

Outcome measures

PrimaryChange 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: * Reaction Time Subtest * Cued Reaction Time Subtest The lower the value, the better the attention.

Time frame:
Change from baseline at Day 4
Reported as:
Least squares mean · milliseconds
Change in Attention Assessment
millisecondsOseltamivirStandard of Care Alone
Change in Attention Assessment-70.0 ± 10.9-39.7 ± 10.9
Statistical analysis
  • Oseltamivir vs Standard of Care Alone · ANCOVA · p = .0492 · Ls means difference: -30.4 · 95% CI -60.7 to -0.1The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.
SecondaryChange in Working Memory Assessment

Working memory assessed with the Dot Memory Test. The higher the value, the better the working memory.

Time frame:
Change from baseline at Day 4
Reported as:
Least squares mean · Number of correct answers
Change in Working Memory Assessment
Number of correct answersOseltamivirStandard of Care Alone
Change in Working Memory Assessment8.2 ± 0.954.4 ± 0.94
Statistical analysis
  • Oseltamivir vs Standard of Care Alone · ANCOVA · p = 0.0054 · Ls means difference: 3.8 · 95% CI 1.14 to 6.42The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.
SecondaryChange in Processing Speed Assessment

Processing speed assessed with the animal number decoding subtest The lower the value, the better the processing speed

Time frame:
Change from baseline at Day 4
Reported as:
Least squares mean · Millliseconds
Change in Processing Speed Assessment
MilllisecondsOseltamivirStandard of Care Alone
Change in Processing Speed Assessment-551.9 ± 77.6-555.8 ± 78.2
Statistical analysis
  • Oseltamivir vs Standard of Care Alone · ANCOVA · p = .9685 · Ls means difference: 3.9 · 95% CI -190.1 to 197.9The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.
Other pre-specifiedChange 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.

Time frame:
Change from baseline at Day 4
Reported as:
Least squares mean · millimeter
Change in Mood Assessment
millimeterOseltamivirStandard of Care Alone
Change in Alertness Assessment19.1 ± 1.417.2 ± 1.4
Change in Calmness Assessment3.0 ± 1.33.6 ± 1.2
Change in Contentedness Assessment16.3 ± 1.513.0 ± 1.5
Statistical analysis
  • Oseltamivir vs Standard of Care Alone · ANCOVA · p = .3195 · Ls means difference: 1.9 · 95% CI -1.9 to 5.7The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.
  • Oseltamivir vs Standard of Care Alone · ANCOVA · p = .7219 · Ls means difference: -.6 · 95% CI -4.1 to 2.9The LS means for Standard of Care AL one was subtracted from that of Oseltamivir.
  • Oseltamivir vs Standard of Care Alone · ANCOVA · p = .1162 · Ls means difference: 3.3 · 95% CI -.8 to 7.4The LS means of Standard of Care Alone was subtracted from that of Oseltamivir.

Adverse events

Collected over 14 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oseltamivir—0/59 (0%)8/59 (13.6%)
Standard of Care Alone—0/63 (0%)8/63 (12.7%)
Most frequent other events
Showing 10 of 15
Most frequent other events
EventOseltamivirStandard of Care Alone
RashSkin and subcutaneous tissue disorders2/591/63
PneumoniaInfections and infestations0/592/63
NauseaGastrointestinal disorders1/590/63
BronchitisInfections and infestations1/590/63
FractureInjury, poisoning and procedural complications1/590/63
PharyngitisInfections and infestations1/590/63
Gastroenteritis viralInfections and infestations1/590/63
HeadacheNervous system disorders1/591/63
DizzinessNervous system disorders1/590/63
ContusionInjury, poisoning and procedural complications0/591/63

Baseline characteristics

Age, Continuous
Age, Continuous(years)OseltamivirStandard of Care AloneTotal
Median37.0 (17 to 66)32.0 (18 to 57)34.0 (17 to 66)
Sex: Female, Male
Sex: Female, Male(Participants)OseltamivirStandard of Care AloneTotal
Female293362
Male303060
Race (NIH/OMB)
Race (NIH/OMB)(Participants)OseltamivirStandard of Care AloneTotal
American Indian or Alaska Native101
Asian121224
Native Hawaiian or Other Pacific Islander000
Black or African American123
White434992
More than one race101
Unknown or Not Reported101
Region of Enrollment
Region of Enrollment(participants)OseltamivirStandard of Care AloneTotal
Canada5963122
Highest Education Level
Highest Education Level(Participants)OseltamivirStandard of Care AloneTotal
Grade 5 - 117310
High School Graduate121931
1 - 3 Years College202444
Bachelor's Degree161329
Post-Graduate448
Current Smoker
Current Smoker(Participants)OseltamivirStandard of Care AloneTotal
Count of participants71421
Time from Symptom Onset
Time from Symptom Onset(hours)OseltamivirStandard of Care AloneTotal
Median33.8 (2.0 to 51.5)36.7 (5.3 to 55.0)35.0 (2.0 to 55.0)
Baseline Symptom Score
Baseline Symptom Score(symptom score)OseltamivirStandard of Care AloneTotal
Median13 (3 to 21)14 (6 to 21)14 (3 to 21)

4 further baseline measures are reported on the registry.

08

Study locations

16 sites
  • Dr. Collette
    Vancouver, British Columbia, Canada
  • Dr. Lai
    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
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2010, a primary completion of Apr 2012 and a completion of Apr 2012. It does not say whether these dates are actual or estimated.

Results were first posted in Mar 2017, 4 years 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2010
First posted
Nov 30, 2010
Start
Nov 2010
Primary completionActual
Apr 2012
CompletionActual
Apr 2012
Results first posted
Mar 9, 2017
Last update
Mar 9, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01249833
Lead sponsor
Trial Management Group Inc.
Collaborators
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Nov 30, 2010
Start date
Nov 2010
Primary completion
Apr 2012
Completion
Apr 2012
Results posted
Mar 9, 2017
Last update
Mar 9, 2017

Study contacts

Dr. O'Mahony, M.D.
principal investigator · London Road Diagnostic Clinic and Medical Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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