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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FujiFilm Pharmaceuticals U.S.A., Inc.
ClinicalTrials.gov Identifier:
NCT01068912
First received: February 12, 2010
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza
 Drug: Favipiravir
Drug: Placebo comparator
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by FujiFilm Pharmaceuticals U.S.A., Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 530
Study Start Date: February 2010
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: Favipiravir
1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
Experimental: 2: Experimental
High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 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
Placebo Comparator: Placebo
Placebo
 Drug: Placebo comparator
Placebo BID x 1 day, and Placebo BID x 4 days

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068912

  Show 228 Study Locations
Sponsors and Collaborators
FujiFilm Pharmaceuticals U.S.A., Inc.
Investigators
Study Director: Macy Guiont INC Research
  More Information

No publications provided

Responsible Party: FujiFilm Pharmaceuticals U.S.A., Inc.
ClinicalTrials.gov Identifier: NCT01068912     History of Changes
Other Study ID Numbers: T705aUS204
Study First Received: February 12, 2010
Last Updated: November 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by FujiFilm Pharmaceuticals U.S.A., Inc.:
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013