Trial Outcomes & Findings for Effect of Oseltamivir on Cognitive Function in Subjects With Influenza (NCT NCT01249833)
NCT ID: NCT01249833
Last Updated: 2017-03-09
Results Overview
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.
COMPLETED
PHASE4
122 participants
Change from baseline at Day 4
2017-03-09
Participant Flow
Participant milestones
| Measure |
Oseltamivir
Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days
|
Standard of Care Alone
Standard of care for influenza
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
63
|
|
Overall Study
COMPLETED
|
59
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Oseltamivir
Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days
|
Standard of Care Alone
Standard of care for influenza
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Data was not collected for 1 patient in each group in error
Baseline characteristics by cohort
| Measure |
Oseltamivir
n=59 Participants
Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days
|
Standard of Care Alone
n=63 Participants
Standard of care for influenza
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.0 years
n=59 Participants
|
32.0 years
n=63 Participants
|
34.0 years
n=122 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=59 Participants
|
33 Participants
n=63 Participants
|
62 Participants
n=122 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=59 Participants
|
30 Participants
n=63 Participants
|
60 Participants
n=122 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=59 Participants
|
0 Participants
n=63 Participants
|
1 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=59 Participants
|
12 Participants
n=63 Participants
|
24 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=59 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=59 Participants
|
2 Participants
n=63 Participants
|
3 Participants
n=122 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=59 Participants
|
49 Participants
n=63 Participants
|
92 Participants
n=122 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=59 Participants
|
0 Participants
n=63 Participants
|
1 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=59 Participants
|
0 Participants
n=63 Participants
|
1 Participants
n=122 Participants
|
|
Region of Enrollment
Canada
|
59 participants
n=59 Participants
|
63 participants
n=63 Participants
|
122 participants
n=122 Participants
|
|
Highest Education Level
Grade 5 - 11
|
7 Participants
n=59 Participants
|
3 Participants
n=63 Participants
|
10 Participants
n=122 Participants
|
|
Highest Education Level
High School Graduate
|
12 Participants
n=59 Participants
|
19 Participants
n=63 Participants
|
31 Participants
n=122 Participants
|
|
Highest Education Level
1 - 3 Years College
|
20 Participants
n=59 Participants
|
24 Participants
n=63 Participants
|
44 Participants
n=122 Participants
|
|
Highest Education Level
Bachelor's Degree
|
16 Participants
n=59 Participants
|
13 Participants
n=63 Participants
|
29 Participants
n=122 Participants
|
|
Highest Education Level
Post-Graduate
|
4 Participants
n=59 Participants
|
4 Participants
n=63 Participants
|
8 Participants
n=122 Participants
|
|
Current Smoker
|
7 Participants
n=59 Participants
|
14 Participants
n=63 Participants
|
21 Participants
n=122 Participants
|
|
Time from Symptom Onset
|
33.8 hours
n=58 Participants • Data was not collected for 1 patient in each group in error
|
36.7 hours
n=62 Participants • Data was not collected for 1 patient in each group in error
|
35.0 hours
n=120 Participants • Data was not collected for 1 patient in each group in error
|
|
Baseline Symptom Score
|
13 symptom score
n=59 Participants
|
14 symptom score
n=63 Participants
|
14 symptom score
n=122 Participants
|
|
Body Temperature
|
38.1 Degrees centigrade
n=59 Participants
|
38.1 Degrees centigrade
n=63 Participants
|
38.1 Degrees centigrade
n=122 Participants
|
|
Health Assessment Question
|
3 Score
n=59 Participants
|
3 Score
n=63 Participants
|
3 Score
n=122 Participants
|
|
Influenza Type
Strain A
|
53 Participants
n=59 Participants
|
52 Participants
n=63 Participants
|
105 Participants
n=122 Participants
|
|
Influenza Type
Strain B
|
6 Participants
n=59 Participants
|
11 Participants
n=63 Participants
|
17 Participants
n=122 Participants
|
|
Cognitive/Mood Conditions
None
|
53 Participants
n=59 Participants
|
60 Participants
n=63 Participants
|
113 Participants
n=122 Participants
|
|
Cognitive/Mood Conditions
ADHD
|
0 Participants
n=59 Participants
|
1 Participants
n=63 Participants
|
1 Participants
n=122 Participants
|
|
Cognitive/Mood Conditions
Anxiety
|
1 Participants
n=59 Participants
|
1 Participants
n=63 Participants
|
2 Participants
n=122 Participants
|
|
Cognitive/Mood Conditions
Depression
|
5 Participants
n=59 Participants
|
1 Participants
n=63 Participants
|
6 Participants
n=122 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at Day 4Population: 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).
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.
Outcome measures
| Measure |
Oseltamivir
n=53 Participants
Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days
|
Standard of Care Alone
n=55 Participants
Standard of care for influenza
|
|---|---|---|
|
Change in Attention Assessment
|
-70.0 milliseconds
Standard Error 10.9
|
-39.7 milliseconds
Standard Error 10.9
|
SECONDARY outcome
Timeframe: Change from baseline at Day 4Population: 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)
Working memory assessed with the Dot Memory Test. The higher the value, the better the working memory.
Outcome measures
| Measure |
Oseltamivir
n=54 Participants
Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days
|
Standard of Care Alone
n=58 Participants
Standard of care for influenza
|
|---|---|---|
|
Change in Working Memory Assessment
|
8.2 Number of correct answers
Standard Error 0.95
|
4.4 Number of correct answers
Standard Error 0.94
|
SECONDARY outcome
Timeframe: Change from baseline at Day 4Population: 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).
Processing speed assessed with the animal number decoding subtest The lower the value, the better the processing speed
Outcome measures
| Measure |
Oseltamivir
n=54 Participants
Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days
|
Standard of Care Alone
n=58 Participants
Standard of care for influenza
|
|---|---|---|
|
Change in Processing Speed Assessment
|
-551.9 Millliseconds
Standard Error 77.6
|
-555.8 Millliseconds
Standard Error 78.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline at Day 4Population: 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).
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.
Outcome measures
| Measure |
Oseltamivir
n=54 Participants
Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days
|
Standard of Care Alone
n=58 Participants
Standard of care for influenza
|
|---|---|---|
|
Change in Mood Assessment
Change in Alertness Assessment
|
19.1 millimeter
Standard Error 1.4
|
17.2 millimeter
Standard Error 1.4
|
|
Change in Mood Assessment
Change in Calmness Assessment
|
3.0 millimeter
Standard Error 1.3
|
3.6 millimeter
Standard Error 1.2
|
|
Change in Mood Assessment
Change in Contentedness Assessment
|
16.3 millimeter
Standard Error 1.5
|
13.0 millimeter
Standard Error 1.5
|
Adverse Events
Oseltamivir
Standard of Care Alone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oseltamivir
n=59 participants at risk
Added to standard of care for influenza
Oseltamivir: Oseltamivir 75mg BID for 5 days
|
Standard of Care Alone
n=63 participants at risk
Standard of care for influenza
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/59 • Number of events 1 • 14 days
|
0.00%
0/63 • 14 days
|
|
Infections and infestations
Bronchitis
|
1.7%
1/59 • Number of events 1 • 14 days
|
0.00%
0/63 • 14 days
|
|
Injury, poisoning and procedural complications
Fracture
|
1.7%
1/59 • Number of events 1 • 14 days
|
0.00%
0/63 • 14 days
|
|
Infections and infestations
Pharyngitis
|
1.7%
1/59 • Number of events 1 • 14 days
|
0.00%
0/63 • 14 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
2/59 • Number of events 4 • 14 days
|
1.6%
1/63 • Number of events 1 • 14 days
|
|
Infections and infestations
Gastroenteritis viral
|
1.7%
1/59 • Number of events 1 • 14 days
|
0.00%
0/63 • 14 days
|
|
Nervous system disorders
Headache
|
1.7%
1/59 • Number of events 1 • 14 days
|
1.6%
1/63 • Number of events 1 • 14 days
|
|
Nervous system disorders
Dizziness
|
1.7%
1/59 • Number of events 1 • 14 days
|
0.00%
0/63 • 14 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/59 • 14 days
|
1.6%
1/63 • Number of events 1 • 14 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/59 • 14 days
|
1.6%
1/63 • Number of events 1 • 14 days
|
|
Psychiatric disorders
Anxiety Disorder
|
0.00%
0/59 • 14 days
|
1.6%
1/63 • Number of events 1 • 14 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/59 • 14 days
|
3.2%
2/63 • Number of events 2 • 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/59 • 14 days
|
1.6%
1/63 • Number of events 1 • 14 days
|
|
Psychiatric disorders
Anger
|
0.00%
0/59 • 14 days
|
1.6%
1/63 • Number of events 1 • 14 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/59 • 14 days
|
1.6%
1/63 • Number of events 1 • 14 days
|
Additional Information
Joanne Morris, Clinical Research Quality Manager
Trial Management Group Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER