Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza
Completed · Phase 2 · Has a placebo group
Conditions studied: Influenza
In brief
This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated influenza.
Key facts
- Study ID
- NCT01068912
- Run by
- MDVI, LLC
- People needed
- 530
- Starts
- 2010-02-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2015-11-18
Who can join
Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients who test positive for influenza A or B by a commercially available Rapid Antigen Test (RAT) of the nasopharynx. A patient with a negative RAT result may still enroll if the sponsor and investigator agree that there is a known influenza outbreak circulating in the community.
- Patients ≥ 20 but < 65 years of age with a temperature (oral) of 100.4°F (38.0°C) or more; patients ≥ 65 years of age with a temperature (oral) of 100.0°F (37.8°C) or more at the first visit, or in the 6 hours prior if antipyretics were taken.
- Patients with 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrollment:
- Cough
- Sore throat
- Headache
- Nasal congestion
- Feeling feverish
- Body aches and pains
- Fatigue (tiredness)
You may not qualify if…
- Patients who have had influenza symptoms or fever (i.e., one of the symptoms listed under the inclusion criteria) for 36 hours or more prior to study screening.
- Patients who have underlying chronic respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], chronic bronchitis, diffuse panbronchiolitis, bronchiectasis, pulmonary emphysema, pulmonary fibrosis, bronchial asthma, or old tuberculosis).
- Patients who at the beginning of the study are suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung in a chest x-ray, etc.).
- Patients who have serious chronic diseases. For example, patients with HIV, cancer (i.e., requiring chemotherapy within the preceding 6 months), cirrhosis (end-stage), and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.
Where it is running
- #156 — Huntsville, Alabama, United States
- #151 — Mobile, Alabama, United States
- #155 — Scottsboro, Alabama, United States
- #173 — Toney, Alabama, United States
- #161 — Tuscumbia, Alabama, United States
- #089 — Chandler, Arizona, United States
- #018 — Green Valley, Arizona, United States
- #110 — Mesa, Arizona, United States
- #105 — Phoenix, Arizona, United States
- #188 — Tucson, Arizona, United States
- #107 — Jonesboro, Arkansas, United States
- #019 — North Little Rock, Arkansas, United States
- #140 — Searcy, Arkansas, United States
- #059 — Anaheim, California, United States
- #179 — Anaheim, California, United States
- #032 — Chino, California, United States
- #154 — Cypress, California, United States
- #004 — Garden Grove, California, United States
- #144 — Long Beach, California, United States
- #043 — Los Angeles, California, United States
- #139 — Los Angeles, California, United States
- #096 — Oxnard, California, United States
- #091 — Pacific Palisades, California, United States
- #114 — Pasadena, California, United States
- #065 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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