Effect of Oseltamivir on Cognitive Function in Subjects With Influenza

NCT01249833 | Completed Phase 4 Results

• 1 other identifier: CAI-001-10
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Influenza

Keywords

Influenza; Cognition; Attention; Simple Reaction Time; Alertness; Calmness; Contentment; Mood

Outcome Measures

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.

  Change from baseline at Day 4

Secondary Outcomes (2)

• Change in Working Memory Assessment

  Change from baseline at Day 4

• Change in Processing Speed Assessment

  Change from baseline at Day 4

Other Outcomes (1)

• Change in Mood Assessment

  Change from baseline at Day 4

Study Arms (2)

Oseltamivir

ACTIVE COMPARATOR

Added to standard of care for influenza

Drug: Oseltamivir

Standard of care alone

NO INTERVENTION

Standard of care for influenza

Interventions

Oseltamivir DRUG

Oseltamivir 75mg BID for 5 days

Also known as: Tamiflu

Oseltamivir

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Fever
• Respiratory symptoms (cough, coryza, sore throat, rhinitis)
• Constitutional symptoms (headache, malaise, myalgia, sweats and/or chills, fatigue)
• 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:
• 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

You may not qualify if:

• More than 2 days since the onset of influenza symptoms
• 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)
• Clinical suspicion of infection with a respiratory virus other than influenza
• Any medical condition that is sufficiently severe or unstable such that the subject is considered to be at imminent risk of requiring hospitalisation
• 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
• 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.
• Intermittent or chronic use of psychiatric medications (with the exception of antidepressants that have been stable for 3 months) or anti-epileptic drugs
• Nursing home residents
• Known allergy to oseltamivir phosphate or any of the inactive ingredients of Tamiflu®
• Women who are pregnant, or planning to become pregnant, or who are lactating
• Current alcohol or drug abuse or substance dependence
• Participation in another clinical trial with an investigational drug within the last 30 days
• Patients vaccinated for influenza within 6 months of study enrollment
• 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

Sponsors & Collaborators

• Trial Management Group Inc.: lead
• Hoffmann-La Roche: collaborator

Study Sites (16)

Dr. Collette

Vancouver, British Columbia, Canada

Location

Dr. Lai

Vancouver, British Columbia, Canada

Location

Topsail Road Medical Clinic

St. John's, Newfoundland and Labrador, Canada

Location

Moran Medical Centre

Collingwood, Ontario, Canada

Location

Dr. Kanani

Etobicoke, Ontario, Canada

Location

Dr. Herman

London, Ontario, Canada

Location

Milestone Research

London, Ontario, Canada

Location

SKDS Research Inc

Newmarket, Ontario, Canada

Location

Family First Medical Centre

Orléans, Ontario, Canada

Location

Steeple Hill Medical Centre

Pickering, Ontario, L1V 2A6, Canada

Location

Dr. Martyn Chilvers - London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, Canada

Location

Dr. Michael O'Mahony - London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, Canada

Location

DCTM Clinical Trials Group Ltd.

Strathroy, Ontario, Canada

Location

Dr. Gupta

Toronto, Ontario, Canada

Location

Devonshire Clinical Research Inc.

Woodstock, Ontario, Canada

Location

Regina Medical Centre

Regina, Saskatchewan, S4P 3X1, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Joanne Morris, Clinical Research Quality Manager
• Organization: Trial Management Group Inc.

joanne@tmginvestigators.com

4169297717

Study Officials

• Dr. O'Mahony, M.D.

  London Road Diagnostic Clinic and Medical Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2010
• First Posted: November 30, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 9, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-01

Locations

CA (16)