NCT01146535

Brief Summary

This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

4 active sites

Status
completed

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

June 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 21, 2013

Status Verified

August 1, 2013

Enrollment Period

1.9 years

First QC Date

June 16, 2010

Last Update Submit

August 19, 2013

Conditions

Influenza A Virus Infection

Keywords

interferon-alphaoseltamivirdrug therapy, combinationinfluenzatherapies, investigational

Outcome Measures

Primary Outcomes (1)

  • Resolution of fever and flu symptoms

    Time to resolution of influenza symptoms defined as all flu symptoms scored as \<=1 and change in viral load (RT-PCR).

    Days 1-5

Secondary Outcomes (8)

  • Clinical response

    Day 3 and Day 6

  • Proportion of poor responders

    Day 3 and Day 6

  • Time to resolution of fever

    Days 1-5

  • Time to resolution of influenza illness

    Days 1-5

  • Symptom improvement

    Days 1-5

  • +3 more secondary outcomes

Study Arms (2)

Interferon-alpha

EXPERIMENTAL

Interferon-alpha 150 IU lozenges bid for 5 days

Drug: Interferon-alphaDrug: Oseltamivir

maltose

PLACEBO COMPARATOR

maltose 200 mg maltose lozenges bid for 5 days

Drug: OseltamivirOther: maltose

Interventions

Interferon-alphaDRUG

150 IU lozenges bid for 5 days

Also known as: IFN lozenge
Interferon-alpha
OseltamivirDRUG

75 mg capsules bid for 5 days

Also known as: Tamiflu
Interferon-alphamaltose
maltoseOTHER

200 mg maltose lozenges bid for 5 days

Also known as: placebo
maltose

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fever \>=38C
  • one or more respiratory symptoms (e.g. cough, rhinorrhea or sore throat) plus one or more constitutional symptoms (e.g. chills, headache, malaise and myalgias)of \< 48 hours' duration
  • body weight \> 40 kg
  • positive for influenza A (nasal swab rapid test)

You may not qualify if:

  • pregnancy/lactation
  • history of depression or psychiatric disorders
  • history of conditions that could complicate flu infection, such as chronic pulmonary, cardiac, renal, or metabolic disorders
  • use of immunosuppressive therapy
  • HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chang Gung Medical Foundation, LinKou Branch

Guishan, Taoyuan County, 333, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Zuoying District, 81362, Taiwan

Location

Show-Chwan Memorial Hospital

Changhua, 800, Taiwan

Location

Taiwan Municipal Hospital

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Interferon-alphaOseltamivirMaltose

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsGlucansPolysaccharidesCarbohydratesDisaccharidesOligosaccharidesSugars

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2010

First Posted

June 17, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 21, 2013

Record last verified: 2013-08

Locations

TW(4)