A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain

NCT01032837 | Terminated Phase 4 Results

• 1 other identifier: NV22155
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 100

Brief Summary

This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this study. Patients will be randomized to one of four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body weight-adjusted for pediatric patients.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Time to Cessation of Viral Shedding

  The time to cessation of viral shedding was measured by viral culture and defined as the time from treatment initiation to the time of the first negative culture with no subsequent positive cultures. Any patient with a positive culture at the last sample time was censored at that time point. Median time to cessation was estimated from the Kaplan-Meier curve.

  Day 1 to Day 40

Secondary Outcomes (9)

• Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture

  Baseline and Days 3, 6, 8, 11, 15 and 40

• Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction

  Baseline and Days 3, 6, 8, 11, 15 and 40

• Change From Baseline in Influenza Titer Measured by Viral Culture

  Baseline, Days 2 through 15

• Number of Participants With Development of Oseltamivir-Resistant Influenza Virus

  40 days

• Time to Resolution of Fever

  Day 1 through Day 40

Study Arms (4)

Oseltamivir standard dose 5 days

EXPERIMENTAL

Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.

Drug: Oseltamivir; Drug: Placebo

Oseltamivir standard dose 10 days

EXPERIMENTAL

Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.

Drug: Oseltamivir; Drug: Placebo

Oseltamivir high dose 5 days

EXPERIMENTAL

Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.

Drug: Oseltamivir; Drug: Placebo

Oseltamivir high dose 10 days

EXPERIMENTAL

Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.

Drug: Oseltamivir; Drug: Placebo

Interventions

Oseltamivir DRUG

Oseltamivir capsules for participants ≥ 13 years.

Also known as: Tamiflu

Oseltamivir high dose 10 days; Oseltamivir high dose 5 days; Oseltamivir standard dose 10 days; Oseltamivir standard dose 5 days

Placebo DRUG

Matching placebo provided as capsules and as a suspension.

Oseltamivir high dose 10 days; Oseltamivir high dose 5 days; Oseltamivir standard dose 10 days; Oseltamivir standard dose 5 days

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pediatric, adolescent and adult patients \>/=1 year of age
• Fever \>/=37.8 degrees C or at least one respiratory symptom (cough, coryza, sore throat, or rhinitis)
• Positive rapid diagnostic test for pandemic (H1N1) 2009 virus or influenza A in the 24 hours prior to the first dose of study drug
• \</=96 hours between onset of influenza-like illness and first dose of oseltamivir

You may not qualify if:

• Currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, or hemofiltration
• History of chronic renal failure or clinical suspicion of renal failure at baseline
• Clinical evidence of hepatic compensation at the time of randomization
• Known HIV infection
• Vaccination with live attenuated influenza vaccine (LAIV) in the two weeks prior to first dose of study medication

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (100)

Unknown Facility

Tuscaloosa, Alabama, 35406, United States

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Phoenix, Arizona, 85016, United States

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Phoenix, Arizona, 85050, United States

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Scottsdale, Arizona, 85248, United States

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Jonesboro, Arkansas, 72401, United States

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Carmichael, California, 95608, United States

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Downey, California, 90241, United States

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Fountain Valley, California, 92708, United States

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Huntington Beach, California, 92647, United States

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Lomita, California, 90717, United States

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National City, California, 91950, United States

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Paramount, California, 90723, United States

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Sacramento, California, 95823, United States

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San Diego, California, 92103-6204, United States

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San Diego, California, 92120, United States

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Colorado Springs, Colorado, 80909, United States

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DeLand, Florida, 32720, United States

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Fleming Island, Florida, 32003, United States

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Gainesville, Florida, 32607, United States

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Jacksonville, Florida, 32205, United States

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Largo, Florida, 33770, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33135, United States

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Orlando, Florida, 32806, United States

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Pembroke Pines, Florida, 33026, United States

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Saint Cloud, Florida, 34769, United States

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Atlanta, Georgia, 30342, United States

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Idaho Falls, Idaho, 83404, United States

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Meridian, Idaho, 83642, United States

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Chicago, Illinois, 60622, United States

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Indianapolis, Indiana, 46268, United States

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Newburgh, Indiana, 47630, United States

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Dubuque, Iowa, 52002, United States

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Overland Park, Kansas, 66210, United States

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Bardstown, Kentucky, 40004, United States

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Madisonville, Kentucky, 42431, United States

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Lake Charles, Louisiana, 70601, United States

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Mandeville, Louisiana, 70471, United States

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Meltairie, Louisiana, 70006, United States

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Shreveprt, Louisiana, 71106, United States

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Brockton, Massachusetts, 02301, United States

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Stevensville, Michigan, 49127, United States

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Bridgeton, Missouri, 63044, United States

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St Louis, Missouri, 63141, United States

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Bozeman, Montana, 59715, United States

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Bellevue, Nebraska, 68005, United States

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Freemont, Nebraska, 68025, United States

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Haddon Heights, New Jersey, 08035, United States

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Sicklerville, New Jersey, 08081, United States

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Camillus, New York, 13031, United States

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Endwell, New York, 13780, United States

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Johnson City, New York, 13790, United States

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Asheboro, North Carolina, 27203, United States

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Burlington, North Carolina, 27215, United States

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Greensboro, North Carolina, 27408, United States

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Harrisburg, North Carolina, 28075, United States

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Mooresville, North Carolina, 28117, United States

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Morganton, North Carolina, 28655, United States

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Raleigh, North Carolina, 27612, United States

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Salisbury, North Carolina, 28144, United States

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Bismarck, North Dakota, 58501, United States

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Canal Fulton, Ohio, 44614, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44121, United States

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Cleveland, Ohio, 44122, United States

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Oklahoma City, Oklahoma, 73112, United States

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Ashland, Oregon, 97520, United States

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Medford, Oregon, 97504, United States

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Collegeville, Pennsylvania, 19426, United States

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Erie, Pennsylvania, 16506, United States

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Jefferson Hills, Pennsylvania, 15025, United States

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Pittsburgh, Pennsylvania, 15236, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Reading, Pennsylvania, 19606, United States

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Scotland, Pennsylvania, 17254, United States

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Upland, Pennsylvania, 19013, United States

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Charleston, South Carolina, 29412, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Simpsonville, South Carolina, 29681, United States

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Bristol, Tennessee, 37620, United States

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Jackson, Tennessee, 38305, United States

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Johnson City, Tennessee, 37604, United States

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Kingsport, Tennessee, 37660, United States

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Bedford, Texas, 76022, United States

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Corpus Christi, Texas, 78411, United States

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Dallas, Texas, 75220, United States

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El Paso, Texas, 79912, United States

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Fort Worth, Texas, 76109, United States

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New Braunfels, Texas, 78130, United States

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San Antonio, Texas, 78215, United States

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San Antonio, Texas, 78238, United States

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Tomball, Texas, 77375, United States

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Clinton, Utah, 84015, United States

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Magna, Utah, 84044, United States

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Salt Lake City, Utah, 84107, United States

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Saratoga Springs, Utah, 84045, United States

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West Jordan, Utah, 84088, United States

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Richmond, Virginia, 23219, United States

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Vienna, Virginia, 22180, United States

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Spokane, Washington, 99204, United States

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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: Medical Communications
• Organization: Hoffman-LaRoche

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 16, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 2, 2012
• Results First Posted: August 20, 2012

Record last verified: 2012-09

Locations

US (100)