InfluenzaPhase 4NCT00436124
A Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza.
A Phase 4 study testing oseltamivir [Tamiflu] in people with Influenza, run by Hoffmann-La Roche at 1 site in Italy.
Trial summary
This study will evaluate the efficacy and safety of Tamiflu in patients with clinically-diagnosed influenza occurring during an influenza outbreak within the community. Patients will be randomized to receive Tamiflu 75mg bid orally plus support therapy (NSAIDs and antibiotics) or support therapy alone. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Influenza
- What is being tested?
- oseltamivir [Tamiflu]
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Jan 2007to Apr 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult patients, 18-64 years of age;
- ambulatory;
- influenza-like illness;
- positive rapid assay for detection of influenza antigen.
Who cannot join
- presentation >36h after onset of symptoms;
- influenza-like symptoms outside an outbreak based on local surveillance activities;
- influenza vaccination between November 2006 and January 2007;
- receipt of antiviral therapy, systemic steroids or immunosuppressants within 2 weeks prior to study day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label Study to Evaluate the Effect of Tamiflu on Viral Shedding and on Serum and Cytoplasmic Inflammatory Cytokine Concentrations in Patients With Laboratory-confirmed Influenza
This study will evaluate the efficacy and safety of Tamiflu in patients with clinically-diagnosed influenza occurring during an influenza outbreak within the community. Patients will be randomized to receive Tamiflu 75mg bid orally plus support therapy (NSAIDs and antibiotics) or support therapy alone. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
- Conditions
- Influenza
- Being tested
- oseltamivir [Tamiflu]
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oseltamivir [Tamiflu]Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12).
Secondary outcomes (1)
Efficacy: Duration of illness, health and functional status, extent and severity of symptoms, incidence of resistant viruses. Safety: AEs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: poor recruitment, no patients were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436124
- Sponsor's protocol ID
- ML20910
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2007
- Last updated
- 17 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Study to Evaluate the Effect of Tamiflu on Viral Shedding and on Serum and Cytoplasmic Inflammatory Cytokine Concentrations in Patients With Laboratory-confirmed Influenza
- ClinicalTrials.gov ID
- NCT00436124
- Acronym / sponsor ID
- ML20910
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment, no patients were enrolled
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2007 (actual)
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 16 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of Tamiflu in patients with clinically-diagnosed influenza occurring during an influenza outbreak within the community. Patients will be randomized to receive Tamiflu 75mg bid orally plus support therapy (NSAIDs and antibiotics) or support therapy alone. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- adult patients, 18-64 years of age;
- ambulatory;
- influenza-like illness;
- positive rapid assay for detection of influenza antigen.
Key exclusion criteria (4 listed)
- presentation >36h after onset of symptoms;
- influenza-like symptoms outside an outbreak based on local surveillance activities;
- influenza vaccination between November 2006 and January 2007;
- receipt of antiviral therapy, systemic steroids or immunosuppressants within 2 weeks prior to study day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oseltamivir [Tamiflu] | Drug | – |
Primary outcome
Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12).
1 secondary outcome
Efficacy: Duration of illness, health and functional status, extent and severity of symptoms, incidence of resistant viruses. Safety: AEs.
Results and safety
The study was stopped early (reason given: poor recruitment, no patients were enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oseltamivir [Tamiflu] in people with Influenza, run by Hoffmann-La Roche at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: poor recruitment, no patients were enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.