Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit

This study has been withdrawn prior to enrollment.
(Study has been withdrawn as the H1N1 epidemic made this study redundant)
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00844155
First received: February 13, 2009
Last updated: April 1, 2010
Last verified: February 2010

February 13, 2009
April 1, 2010
March 2009
July 2009   (final data collection date for primary outcome measure)
Oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults . [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00844155 on ClinicalTrials.gov Archive Site
Test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability. [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit
A Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir (Tamiflu®) in Patients in the Intensive Care Unit

This proposed pharmacokinetic study will test the hypothesis that in critically ill patients with respiratory failure requiring mechanical ventilation such as might be anticipated to be needed to treat patients with severe influenza pneumonia, oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults ill with influenza in whom oseltamivir therapy 75 mg BID is efficacious and well tolerated. Additionally, this experiment will test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability. Relative oral bioavailability will be assessed from plasma concentration vs. time over 12 hrs and urinary recovery of drug from 0 to 48 hrs after administration.

Not required

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Influenza A Virus Infection
  • Influenza B Virus Infection
Drug: Oseltamivir 75 mg
The primary objective of this study is to demonstrate that the pharmacokinetics of oseltamivir, when given enterally to critically ill patients, in the standard treatment dose of 75 mg or double that dose, 150 mg, will yield a plasma concentration - versus - Time Area under the curve (AUC) similar to that observed in adults with influenza treated successfully with a dose of 75 mg, that the disposition characteristics are dose proportionate and are not altered by the concomitant administration of enteral feedings.
Other Name: Tamiflu
  • Active Comparator: A.Oseltamivir 75 mg dose
    Patients will be randomized to two groups (group A) to receive oseltamivir at 75 mg, or (group B) to receive the drug at 150 mg in the fasting or fed state.
    Intervention: Drug: Oseltamivir 75 mg
  • Active Comparator: B. Oseltamivir 150mg
    Patients will be randomized to groups (group A) to receive oseltamivir at 75 mg, or group B to receive the drug at 150 mg in the fasting or fed state.
    Intervention: Drug: Oseltamivir 75 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients admitted to the Intensive Care Unit requiring mechanical ventilation due to respiratory failure
  • must be within the ages of 18-75 yrs

Exclusion Criteria:

  • patients unable to have enteral feeding
  • intolerance to oseltamivir
  • pregnancy
  • gastrointestinal or malabsorptive disease
  • intestinal bypass surgery
  • diarrhea (>2 loose bowel movements per day)
  • receipt of prokinetic medications (metoclopramide, domperidone, erythromycin)
  • severe liver disease (hepatocellular enzymes > 3 times the upper limit of normal)
  • renal failure (Cockroft-Gault Creatinine Clearance < 30 ml/min, Dialysis dependant)
  • cystic fibrosis
  • intoxication or drug overdose
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00844155
#ML25018, Contract ID # 17908C
No
Faisal Siddiqui MD, University of Manitoba
University of Manitoba
Hoffmann-La Roche
Principal Investigator: Faisal Siddiqui, MD University of Manitoba
University of Manitoba
February 2010

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