NCT00979667

Brief Summary

To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza A (H1N1) virus.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_3

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 11, 2011

Status Verified

May 1, 2010

Enrollment Period

10 months

First QC Date

September 17, 2009

Last Update Submit

April 8, 2011

Conditions

Upper Respiratory Tract InfectionInfluenza

Keywords

Upper respiratory tract infectionInfluenza AHuman Swine Influenza

Outcome Measures

Primary Outcomes (1)

  • Time to symptoms resolution as reported by the patient

    one week

Secondary Outcomes (3)

  • Treatment failure including hospitalization due to disease worsening.

    one week

  • Viral load

    one week

  • Severity of disease as measured by the patient diary and quality of life using SF12v2.

    one week

Study Arms (3)

Oseltamivir

EXPERIMENTAL
Drug: Oseltamivir

Zanamivir

EXPERIMENTAL
Drug: Zanamivir

Placebo of Oseltamivir

PLACEBO COMPARATOR
Drug: Placebo of Oseltamivir

Interventions

OseltamivirDRUG

75 mg twice daily for 5 days

Also known as: Tamiflu
Oseltamivir
ZanamivirDRUG

10 mg twice daily for 5 days

Also known as: Relenza
Zanamivir
Placebo of OseltamivirDRUG

twice daily for 5 days

Also known as: Tamiflu Placebo
Placebo of Oseltamivir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients 18 years or older with body weight \>40kg
  • Written informed consent
  • Presented within 48 hours of onset of influenza-like illness
  • Presumptive diagnosis of H1N1 satisfying the following clinical and laboratory criteria:
  • Clinical criteria
  • Fever \>38 oC (Infrared Forehead Thermometer will be used to measure the Temporal Artery Temperature under the skin) AND
  • At least one upper respiratory tract infection (cough, running nose, sore throat)
  • Laboratory criteria Positive rapid test result for influenza A (by Influenza Rapid Diagnostic test) within 48 hours of onset of flu-like symptoms

You may not qualify if:

  • Age below 18 years
  • Persons who lack the ability to care for themselves
  • Patient with critical condition or already developed severe respiratory distress with hypoxaemia on presentation
  • Pregnancy or lactation
  • Coexisting liver disease
  • Coexisting cardiovascular disease except stable hypertension without complication
  • Coexisting chronic pulmonary disease
  • Coexisting immuno-compromised medical conditions or on concurrent immunosuppressive therapies
  • Renal failure
  • Terminal malignancies or terminal end-organ failure with an estimated life-expectancy of less than 3 months
  • Known intolerance to oseltamivir or zanamivir
  • Known history of significant neurological disorders that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk for aspiration or those
  • Subjects who have received oseltamivir as prophylaxis for H1N1 infection
  • Subjects who have received any investigational drug within 1 month prior to study entry
  • Subjects with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shau Kei Wan Jockey Club Clinic

Hong Kong, Hong Kong, 852, China

Location

Fanling Family Medicine Centre

Hong Kong, Hong Kong

Location

Sai Ying Pun Jockey Club General Outpatient Clinic

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsInfluenza, Human

Interventions

OseltamivirZanamivir

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesOrthomyxoviridae InfectionsRNA Virus InfectionsVirus Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsGuanidinesAmidinesSialic AcidsNeuraminic AcidsSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmino SugarsCarbohydrates

Study Officials

  • Augustine T. LAM, MBBS

    Prince of Wales Hospital, Shatin, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 17, 2009

First Posted

September 18, 2009

Study Start

October 1, 2009

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

April 11, 2011

Record last verified: 2010-05

Locations

CN(1)HK(2)