Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MDVI, LLC
ClinicalTrials.gov Identifier:
NCT01068912
First received: February 12, 2010
Last updated: May 19, 2014
Last verified: May 2014

February 12, 2010
May 19, 2014
February 2010
April 2012   (final data collection date for primary outcome measure)
Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
Overall time required from first study drug administration to alleviation of the 6 primary influenza symptoms and for temperature (oral) measurements to be less than 38.0°C for patients aged 20 to less than 65 years and less than 37.8°C for patients aged 65 years or older. "Alleviated" was defined as all 6 symptom scores had to be decreased to 1 or below and the decrease remain unchanged for 21.5 hours.
To evaluate the clinical efficacy of 2 dose regimens of favipiravir compared with placebo in treating patients with influenza [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01068912 on ClinicalTrials.gov Archive Site
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Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza
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

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.

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of a 5-day regimen of favipiravir in influenza patients aged 20-80 years. Enrolled patients will be randomly assigned to 1 of 3 parallel treatment dose groups:Placebo; Low-dose favipiravir (1000 mg favipiravir BID for 1 day, followed by 400 mg favipiravir BID for 4 days); High-dose favipiravir (1200 mg favipiravir BID for 1 day, followed by 800 mg favipiravir BID for 4 days).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Influenza
  • Drug: Favipiravir
    1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
  • Drug: Favipiravir
    High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
  • Drug: Placebo comparator
    Placebo BID x 1 day, and Placebo BID x 4 days
  • Experimental: 1: Experimental
    Low-dose favipiravir regimen: 1000 mg favipiravir twice a day (BID) x 1 day, and 400 mg favipiravir BID x 4 days
    Intervention: Drug: Favipiravir
  • Experimental: 2: Experimental
    High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
    Intervention: Drug: Favipiravir
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
530
May 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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)

Exclusion Criteria:

  1. 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.
  2. 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).
  3. 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.).
  4. 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.
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Chile,   New Zealand,   Paraguay,   Peru,   South Africa
 
NCT01068912
T705aUS204
Yes
MDVI, LLC
MDVI, LLC
Not Provided
Study Director: Macy Guiont INC Research
MDVI, LLC
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP