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Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza (Igloo)

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
40 mg Laninamivir Octanoate
80 mg Laninamivir Octanoate
Placebo
Sponsored by
Biota Scientific Management Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza focused on measuring Influenza Laninamivir Octanoate

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  1. Provide written informed consent
  2. Males or females aged 18-64 years, inclusive

  3. Symptomatic presumptive influenza A or B infection defined as the presence of:

    1. a fever of ≥38.0ºC (≥100.4 ºF) at the screening visit OR a history of fever within the 24 hours prior to the screening visit and has administered antipyretic(s) in the 6 hours prior to the screening visit AND
    2. ≥1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) AND
    3. ≥1 moderate respiratory symptom (cough, sore throat and nasal congestion)

  4. Onset of illness no more than 40 hours prior to randomization. Onset of illness is defined as the time, the first of any one of the following, occurred:

    1. time when the subjects' temperature was measured as elevated (≥38.0°C (≥100.4ºF) OR
    2. time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion) OR
    3. time when the subject first experienced at least one systemic symptom (headache, feeling feverish, body aches and pains, and fatigue)

Main Exclusion Criteria:

  1. Use of antiviral treatment for influenza (e.g. zanamivir, oseltamivir, rimantadine, or amantadine) within 14 days prior to screening
  2. Received live attenuated or trivalent inactivated influenza virus vaccine in the previous 3 weeks.
  3. History or presence of clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis) or asthma
  4. History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status (See Appendix A: ) within the past 12 months
  5. Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants
  6. Presence of clinically significant signs of acute respiratory distress during screening
  7. Current use of inhaled medications (nasal or oral) or anticipated use of inhaled medications (nasal or oral) at any time during the study.
  8. Current or a history of acute or chronic renal impairment requiring hemodialysis and/or a known or calculated creatinine clearance (CLCR) of <60 mL/min
  9. History or presence of any clinical condition or evidence of organ dysfunction on examination which, in the opinion of the investigator, may affect either the subject's ability to participate in the study or the study results

Sites / Locations

  • Scottsboro Quick Care Clinic
  • Clinical Trial Connection
  • Warner Family Practice
  • Clinical Research Connections, LLC
  • NEA Baptist Clinic
  • eStudySite
  • Beach Physicians Medical Group, Inc.
  • eStudySite
  • Novo Research, Inc.
  • Lucita M. Cruz, MD, Inc
  • eStudySite
  • Clinical Trials of Orange County, Inc
  • California Research Foundation
  • San Diego Sports Medicine & Family Health Center
  • Orange County Research Center, Inc
  • SC Clinical Research, Inc.
  • Complete Family Care
  • BRCR Medical Center, Inc DBA Boca Raton Clinical Research
  • Zasa Clinical Research, LLC
  • Southeast Clinical Research, LLC
  • Sanitas Research
  • Southeast Clinical Research, LLC - Parent
  • Crystal Biomedical Research
  • Columbus Clinical Services, LLC
  • New Horizon Research Center, Inc
  • DCT - FMC, LLC, d/b/a Discovery Clinical Trials
  • Advanced Medical Research Center
  • Dr. B. Abraham, PC
  • Women's Healthcare Associates P.A.
  • Baptist Health Clinical Studies
  • Clinical Trials Management, LLC
  • Clinical Trials Management, LLC
  • Medipharmics, LLC
  • KAMP Medical Research
  • Paul Shapero, MD
  • Bethesda Allergy, Asthma & Research Center, LLC
  • Neccr Imca, Llc
  • University of Massachusetts Medical Center
  • Oakland Medical Research Center
  • Olive Branch Family Medical Center
  • Pioneer Clinical Research, LLC
  • The Asthma & Allergy Center, P.C. master
  • Beacom Family Health Connection
  • eStudySite
  • Comprehensive Clinical Research
  • PMG Research of Hickory, LLC
  • Sentral Clinical Research Services, LLC
  • Hometown Urgent Care & Occupational Health
  • ProMedica Health System, Inc
  • Vital Prospects Clinical Research Institute, P.C.
  • Detweiler Family Medicine & Associates
  • Warminster Medical Associates, PC
  • AAPRI Clinical Research Institute
  • Hillcrest Clinical Research, LLC
  • Clinical Research Solutions, PC
  • HCCA Clinical Research Solutions
  • Clinical Research Solutions, PC
  • HCCA Clinical Research Solutions
  • PMG Research of Knoxville
  • Clinical Research Solutions, PC
  • Clinical Research Solutions, PC
  • ACRC Trials
  • Sun Research Institute, LLC
  • Oakwell Clinical Research
  • DBA Southwest Clinic
  • DCT-Stone Oak, LLC dba Discovery Clinical Trials
  • Westside Medical
  • Focus Clinical Research
  • J. Lewis Research - FirstMed East
  • Carilion Infectious Disease
  • Dr Doong's Surgery
  • Hyde Park Medical
  • Westmead Hospital
  • Cairns Base Hospital
  • Jimboomba Junction Family Practice & Skin Cancer Clinic
  • Mermaid Beach Medical Centre
  • Morayfield 7 Day Medical Centre
  • AusTrials Pty Ltd. Sherwood
  • Pain & Anaesthesia Research Clinic
  • Hunter Clinical Research
  • Dokter Luc Timmermans
  • Vereecken Guy
  • Calozet, Yven
  • Hutsebaut, Andre
  • Van Mulders, Norbert
  • Parque, Jean-Luc
  • Mortelmans, Jaak
  • Private Practice
  • BVBA Dr. Luc Capiau
  • SHATPPD-Ruse EOOD
  • DCARC "Hill Clinic"
  • Diagnostic Consultative Center II - Sofia OOD
  • Fifth MHAT-Sofia, EAD
  • MHAT "Lyulin", EAD
  • Military Medical Academy - MHAT - Sofia
  • NMTH "Tsar Boris III"
  • UMHAT " Alexandrovska" EAD
  • UMHAT 'Lozenets"
  • MDHAT Dr Stefan Cherkezov, AD
  • Aggarwal and Associates Ltd
  • Dr. Anil K. Gupta Medicine Professional Corporation
  • SKDS Research Inc.
  • Omnispec Clinical Research Inc
  • Clinique Medicale St-Louis (Recherche) Inc
  • Administradora Country S.A.
  • Centro de Investigacion Clinica - CAFAM
  • Clinica Colsanitas S.A. sede Clinica Universitaria Columbia
  • Vee Family Doctor's Center OY
  • Medicum Perearstikeskus AS
  • Meie Tervis OU
  • Merekivi Perearstid OU
  • Merelahe Family Doctors Centre
  • Mustamae Health Centre
  • Pirita Family Doctors Centre
  • Dr Monika Vask Ltd.
  • Marje Toom Family Doctors Practice
  • Cabinet Medical
  • Cabinet Medical
  • Cabinet Medical
  • Cabinet Medical - Alain Boye
  • Cabinet Medical
  • Cabinet Medical Jacques Marty
  • Cabinet Medical Jean Charcot
  • Cabinet Medical
  • Institut fuer Praeventive Medizin Freiburg
  • Gemeinschaftspraxis Dr. med. Reinhold Jerwan-Keim, Renate Metz
  • Gemeinschaftspraxis Dres. Hagemann, Duerfeld und Breiderhoff
  • Hausarztzentrum Bocholder Strasse
  • Medizentrum Essen Borbeck
  • Unterfrintroper Hausarztzentrum
  • medicoKIT
  • Gemeinschaftspraxis Heisters und Sungen
  • Gemeinschaftspraxis Dres. Kleinecke-Pohl, Kirsch, Benner-Hemsen
  • ABX-CRO advanced pharmaceuticals Forschungsqesellschaft mbH
  • Praxis Dr. Schiewe
  • Clinexpert Egeszsegugyi Szolg. es Ker. Kft.
  • CSALADGYOGYYASZ Szolgaltato es Oktato Bt.
  • Haziorvosi Rendelo
  • QUALICLINIC Eu-i Szolg. es Kutatasszervezo Kft
  • Kenezy Korhaz es Rendelointezet
  • Bekes Megyei Pandy Kalman Korhaz
  • Felnott Haziorvosi Rendelo
  • Haziorvosi Rendelo
  • Felnott Haziorvosi Rendelo
  • Revamed Kft.
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Liga Kozlovska Family Doctor Practice
  • Jelgava Outpatient Clinic
  • Dr. R. Eglite's Private Practice
  • Dr. Dz.Trosk's practice
  • Regional Hospital of Liepaja
  • Hospital of Reseknes
  • Clinic of GP A.Lasmanis "ALMA"
  • Vecverdina Vizma - GP Practice
  • Centro de Investigacion Clinica Acelerada, S.C.
  • Centro de Investigacion Clinica GRAMEL S.C
  • Facultad Mexicana de Medicina, Universidad La Salle A.C.
  • Hospital Angeles Lindavista
  • Mexico Centre for Clinical Research S.A. de C.V
  • Phylasis Clinicas Research S de RL de CV
  • Clinical Research Institute S.C.
  • Centro de Investigacion Medico Biologica y Terapia Avanzada (CIMBYTA)
  • Hospital de Especialidades Centro Medico Puerta de Hierro
  • Centro de Investigaction y Transferencia en Salud del Tecnologico de Monterrey
  • Hospital Universitario de Monterrey
  • Nucleo Victoria de Investigacion Clinica S.C.
  • Oaxaca Site Management Organization S.C.
  • Optimal Clinical Trials
  • Primorus Clinical Trials Ltd
  • Shirley Medical Centre
  • Clinical Trials New Zealand Ltd
  • Auckland Family Medical Centre
  • Hospital Nacional Carlos Alberto Seguin Escobedo
  • Hospital Nacional Adolfo Guevara Velasco
  • Clinica Internacional Sede San Borja
  • Clinica San Borja
  • Hospital Maria Auxiliadora
  • Hospital Nacional Arzobispo Loayza
  • Global Clinical Trials PE
  • Iatros International
  • Josha Research
  • Drs YAK Vahed and Partners
  • Maphutha, MB
  • Medicross Roodepoort Clinical Research
  • Clinresco Centres (Pty) Ltd
  • DJW Research
  • Synexus SA, Stanza Bopape Clinical Research Centre
  • Emmed Research
  • Engelbrecht, I
  • Global Clinical Trials Pretoria
  • Jongaie Research
  • Synexus SA - Watermeyer Clinical Research Centre
  • Syzygy Clinical Research Services Wilgers
  • University of Pretoria Clinical Research Unit
  • De Villiers Clinical Trials
  • Sebastian, Peter
  • Synapta Clinical Research
  • van Rensburg, CJJ
  • Vawda, ZFA
  • Brookdale Clinical Research Centre
  • Richards Bay Trial Centre (Pty) Ltd
  • Aliwal Shoal Medical Centre
  • Limpopo Clinical Research Initiative
  • Mzansi Ethical Research Centre
  • Africa International Research
  • Allergy Diagnostic & Clinical Research Unit
  • Boyd, WV
  • Helderberg Clinical Trials Centre
  • Langeberg Clinical Trials
  • Tiervlei Trial Centre
  • Western Cape Clinical Trials
  • Excellentis Clinical Trial Consultants
  • Somerset West Clinical Trial Unit
  • Clinical Projects Research SA (PTY) LTD
  • Staploe Medical Centre
  • Avondale Surgery Research
  • Knowle House Surgery
  • Sheepcot Medical Centre
  • CPS Ltd
  • Holbrook Lane Surgery
  • Bradford on Avon Health Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

40 mg Laninamivir Octanoate DPI

80 mg Laninamivir Octanoate DPI

Placebo

Arm Description

40 mg Laninamivir Octanoate and matching placebo

80 mg Laninamivir

Matching Placebo

Outcomes

Primary Outcome Measures

Time to Alleviation of Influenza Symptoms
Time to alleviation of influenza will be assessed through Flu-iiQ (Influenza intensity and impact Questionnaire) and diary cards from Day 1 to 14.

Secondary Outcome Measures

Full Information

First Posted
February 13, 2013
Last Updated
May 29, 2018
Sponsor
Biota Scientific Management Pty Ltd
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT01793883
Brief Title
Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza
Acronym
Igloo
Official Title
A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Symptomatic Influenza A or B Infection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biota Scientific Management Pty Ltd
Collaborators
Department of Health and Human Services

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.
Detailed Description
Approximately 636 subjects will be randomized into the Study. Following confirmation of circulating influenza in the local area, eligible subjects with recent onset of symptomatic presumptive influenza A or B infection will be enrolled in the study. Subjects must be randomized within 40 hours of the first symptom onset. Subjects will be randomized to placebo, 40 or 80 mg of laninamivir octanoate. The study will be conducted on an outpatient basis. The first dose of study drug will be administered via inhalation within 4 hours of randomization in the clinic, followed by a second dose at home. Participants will be followed for 14 days to assess efficacy, virology and safety. Outpatient visits to the investigational site are scheduled on Days 2 (optional PK Sub-study Visit) 3, 5, 8, 15. An End of study visit will be performed on Day 29.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza Laninamivir Octanoate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
639 (Actual)

8. Arms, Groups, and Interventions

Arm Title
40 mg Laninamivir Octanoate DPI
Arm Type
Active Comparator
Arm Description
40 mg Laninamivir Octanoate and matching placebo
Arm Title
80 mg Laninamivir Octanoate DPI
Arm Type
Active Comparator
Arm Description
80 mg Laninamivir
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo
Intervention Type
Drug
Intervention Name(s)
40 mg Laninamivir Octanoate
Other Intervention Name(s)
CS-8958
Intervention Type
Drug
Intervention Name(s)
80 mg Laninamivir Octanoate
Other Intervention Name(s)
CS-8958
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Lactose
Primary Outcome Measure Information:
Title
Time to Alleviation of Influenza Symptoms
Description
Time to alleviation of influenza will be assessed through Flu-iiQ (Influenza intensity and impact Questionnaire) and diary cards from Day 1 to 14.
Time Frame
Efficacy will be assessed over 14 days post-randomization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Provide written informed consent Males or females aged 18-64 years, inclusive Symptomatic presumptive influenza A or B infection defined as the presence of: a fever of ≥38.0ºC (≥100.4 ºF) at the screening visit OR a history of fever within the 24 hours prior to the screening visit and has administered antipyretic(s) in the 6 hours prior to the screening visit AND ≥1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) AND ≥1 moderate respiratory symptom (cough, sore throat and nasal congestion) Onset of illness no more than 40 hours prior to randomization. Onset of illness is defined as the time, the first of any one of the following, occurred: time when the subjects' temperature was measured as elevated (≥38.0°C (≥100.4ºF) OR time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion) OR time when the subject first experienced at least one systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) Main Exclusion Criteria: Use of antiviral treatment for influenza (e.g. zanamivir, oseltamivir, rimantadine, or amantadine) within 14 days prior to screening Received live attenuated or trivalent inactivated influenza virus vaccine in the previous 3 weeks. History or presence of clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis) or asthma History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status (See Appendix A: ) within the past 12 months Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants Presence of clinically significant signs of acute respiratory distress during screening Current use of inhaled medications (nasal or oral) or anticipated use of inhaled medications (nasal or oral) at any time during the study. Current or a history of acute or chronic renal impairment requiring hemodialysis and/or a known or calculated creatinine clearance (CLCR) of <60 mL/min History or presence of any clinical condition or evidence of organ dysfunction on examination which, in the opinion of the investigator, may affect either the subject's ability to participate in the study or the study results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Lambert, PhD
Organizational Affiliation
Biota Scientific Management Pty Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Scottsboro Quick Care Clinic
City
Scottsboro
State/Province
Alabama
ZIP/Postal Code
35768
Country
United States
Facility Name
Clinical Trial Connection
City
Camp Verde
State/Province
Arizona
ZIP/Postal Code
86322
Country
United States
Facility Name
Warner Family Practice
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Clinical Research Connections, LLC
City
Harrisburg
State/Province
Arkansas
ZIP/Postal Code
72432
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
eStudySite
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Beach Physicians Medical Group, Inc.
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
eStudySite
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Novo Research, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90813-3296
Country
United States
Facility Name
Lucita M. Cruz, MD, Inc
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
eStudySite
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Clinical Trials of Orange County, Inc
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92103-6204
Country
United States
Facility Name
San Diego Sports Medicine & Family Health Center
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Orange County Research Center, Inc
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
SC Clinical Research, Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Complete Family Care
City
Northglenn
State/Province
Colorado
ZIP/Postal Code
80234
Country
United States
Facility Name
BRCR Medical Center, Inc DBA Boca Raton Clinical Research
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
Zasa Clinical Research, LLC
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Southeast Clinical Research, LLC
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
Sanitas Research
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Southeast Clinical Research, LLC - Parent
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Crystal Biomedical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Columbus Clinical Services, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
New Horizon Research Center, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
DCT - FMC, LLC, d/b/a Discovery Clinical Trials
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Advanced Medical Research Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Dr. B. Abraham, PC
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30039
Country
United States
Facility Name
Women's Healthcare Associates P.A.
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Baptist Health Clinical Studies
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431-1665
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Mandeville
State/Province
Louisiana
ZIP/Postal Code
70471
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Medipharmics, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
KAMP Medical Research
City
Natchitoches
State/Province
Louisiana
ZIP/Postal Code
71457
Country
United States
Facility Name
Paul Shapero, MD
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Bethesda Allergy, Asthma & Research Center, LLC
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Neccr Imca, Llc
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
University of Massachusetts Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Oakland Medical Research Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Olive Branch Family Medical Center
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Pioneer Clinical Research, LLC
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
Facility Name
The Asthma & Allergy Center, P.C. master
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123-4303
Country
United States
Facility Name
Beacom Family Health Connection
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
eStudySite
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
PMG Research of Hickory, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Sentral Clinical Research Services, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Hometown Urgent Care & Occupational Health
City
Milford
State/Province
Ohio
ZIP/Postal Code
45150
Country
United States
Facility Name
ProMedica Health System, Inc
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, P.C.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Detweiler Family Medicine & Associates
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Warminster Medical Associates, PC
City
Warminster
State/Province
Pennsylvania
ZIP/Postal Code
18974
Country
United States
Facility Name
AAPRI Clinical Research Institute
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Hillcrest Clinical Research, LLC
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Clinical Research Solutions, PC
City
Columbia
State/Province
Tennessee
ZIP/Postal Code
38401
Country
United States
Facility Name
HCCA Clinical Research Solutions
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Clinical Research Solutions, PC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
HCCA Clinical Research Solutions
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
Clinical Research Solutions, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Clinical Research Solutions, PC
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
ACRC Trials
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Sun Research Institute, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Oakwell Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
DBA Southwest Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78221-1615
Country
United States
Facility Name
DCT-Stone Oak, LLC dba Discovery Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Westside Medical
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Focus Clinical Research
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
J. Lewis Research - FirstMed East
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Carilion Infectious Disease
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Dr Doong's Surgery
City
Burwood
State/Province
New South Wales
Country
Australia
Facility Name
Hyde Park Medical
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Westmead Hospital
City
Wentworthville
State/Province
New South Wales
Country
Australia
Facility Name
Cairns Base Hospital
City
Cairns
State/Province
Queensland
Country
Australia
Facility Name
Jimboomba Junction Family Practice & Skin Cancer Clinic
City
Jimboomba
State/Province
Queensland
Country
Australia
Facility Name
Mermaid Beach Medical Centre
City
Mermaid Beach
State/Province
Queensland
Country
Australia
Facility Name
Morayfield 7 Day Medical Centre
City
Morayfield
State/Province
Queensland
Country
Australia
Facility Name
AusTrials Pty Ltd. Sherwood
City
Sherwood
State/Province
Queensland
Country
Australia
Facility Name
Pain & Anaesthesia Research Clinic
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Hunter Clinical Research
City
Broadmeadows
State/Province
Victoria
Country
Australia
Facility Name
Dokter Luc Timmermans
City
Borgerhout
Country
Belgium
Facility Name
Vereecken Guy
City
Halen
Country
Belgium
Facility Name
Calozet, Yven
City
Herbeumont
Country
Belgium
Facility Name
Hutsebaut, Andre
City
Moerkerke
Country
Belgium
Facility Name
Van Mulders, Norbert
City
Moorsel
Country
Belgium
Facility Name
Parque, Jean-Luc
City
Mouscron
Country
Belgium
Facility Name
Mortelmans, Jaak
City
Oostham
Country
Belgium
Facility Name
Private Practice
City
Oudenaarde
Country
Belgium
Facility Name
BVBA Dr. Luc Capiau
City
Wetteren
Country
Belgium
Facility Name
SHATPPD-Ruse EOOD
City
Ruse
Country
Bulgaria
Facility Name
DCARC "Hill Clinic"
City
Sofia
Country
Bulgaria
Facility Name
Diagnostic Consultative Center II - Sofia OOD
City
Sofia
Country
Bulgaria
Facility Name
Fifth MHAT-Sofia, EAD
City
Sofia
Country
Bulgaria
Facility Name
MHAT "Lyulin", EAD
City
Sofia
Country
Bulgaria
Facility Name
Military Medical Academy - MHAT - Sofia
City
Sofia
Country
Bulgaria
Facility Name
NMTH "Tsar Boris III"
City
Sofia
Country
Bulgaria
Facility Name
UMHAT " Alexandrovska" EAD
City
Sofia
Country
Bulgaria
Facility Name
UMHAT 'Lozenets"
City
Sofia
Country
Bulgaria
Facility Name
MDHAT Dr Stefan Cherkezov, AD
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
Aggarwal and Associates Ltd
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Dr. Anil K. Gupta Medicine Professional Corporation
City
Etobicoke
State/Province
Ontario
Country
Canada
Facility Name
SKDS Research Inc.
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Omnispec Clinical Research Inc
City
Mirabel
State/Province
Quebec
Country
Canada
Facility Name
Clinique Medicale St-Louis (Recherche) Inc
City
Quebec
Country
Canada
Facility Name
Administradora Country S.A.
City
Bogota
Country
Colombia
Facility Name
Centro de Investigacion Clinica - CAFAM
City
Bogota
Country
Colombia
Facility Name
Clinica Colsanitas S.A. sede Clinica Universitaria Columbia
City
Bogota
Country
Colombia
Facility Name
Vee Family Doctor's Center OY
City
Paide
Country
Estonia
Facility Name
Medicum Perearstikeskus AS
City
Tallinn
Country
Estonia
Facility Name
Meie Tervis OU
City
Tallinn
Country
Estonia
Facility Name
Merekivi Perearstid OU
City
Tallinn
Country
Estonia
Facility Name
Merelahe Family Doctors Centre
City
Tallinn
Country
Estonia
Facility Name
Mustamae Health Centre
City
Tallinn
Country
Estonia
Facility Name
Pirita Family Doctors Centre
City
Tallinn
Country
Estonia
Facility Name
Dr Monika Vask Ltd.
City
Tartu
Country
Estonia
Facility Name
Marje Toom Family Doctors Practice
City
Voru
Country
Estonia
Facility Name
Cabinet Medical
City
La Bouexiere
State/Province
Ille Et Vilaine
Country
France
Facility Name
Cabinet Medical
City
Tours
State/Province
Indre Et Loire
Country
France
Facility Name
Cabinet Medical
City
La Montagne
State/Province
Loire Atlantique
Country
France
Facility Name
Cabinet Medical - Alain Boye
City
Nantes
State/Province
Loire Atlantique
Country
France
Facility Name
Cabinet Medical
City
Briollay
State/Province
Maine Et Loire
Country
France
Facility Name
Cabinet Medical Jacques Marty
City
Murs-Erigne
State/Province
Maine Et Loire
Country
France
Facility Name
Cabinet Medical Jean Charcot
City
Segre
State/Province
Maine Et Loire
Country
France
Facility Name
Cabinet Medical
City
Vihiers
Country
France
Facility Name
Institut fuer Praeventive Medizin Freiburg
City
Freiburg
State/Province
Baden Wuerttemberg
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. Reinhold Jerwan-Keim, Renate Metz
City
Dietzenbach
State/Province
Hessen
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Hagemann, Duerfeld und Breiderhoff
City
Essen
State/Province
Nordrhein Westfalen
Country
Germany
Facility Name
Hausarztzentrum Bocholder Strasse
City
Essen
State/Province
Nordrhein Westfalen
Country
Germany
Facility Name
Medizentrum Essen Borbeck
City
Essen
State/Province
Nordrhein Westfalen
Country
Germany
Facility Name
Unterfrintroper Hausarztzentrum
City
Essen
State/Province
Nordrhein Westfalen
Country
Germany
Facility Name
medicoKIT
City
Goch
State/Province
Nordrhein Westfalen
Country
Germany
Facility Name
Gemeinschaftspraxis Heisters und Sungen
City
Kamp-Lintfort
State/Province
Nordrhein Westfalen
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Kleinecke-Pohl, Kirsch, Benner-Hemsen
City
Koein
State/Province
Nordrhein Westfalen
Country
Germany
Facility Name
ABX-CRO advanced pharmaceuticals Forschungsqesellschaft mbH
City
Dresden
State/Province
Sachsen
Country
Germany
Facility Name
Praxis Dr. Schiewe
City
Hamburg
Country
Germany
Facility Name
Clinexpert Egeszsegugyi Szolg. es Ker. Kft.
City
Budapest
Country
Hungary
Facility Name
CSALADGYOGYYASZ Szolgaltato es Oktato Bt.
City
Budapest
Country
Hungary
Facility Name
Haziorvosi Rendelo
City
Budapest
Country
Hungary
Facility Name
QUALICLINIC Eu-i Szolg. es Kutatasszervezo Kft
City
Budapest
Country
Hungary
Facility Name
Kenezy Korhaz es Rendelointezet
City
Debrecen
Country
Hungary
Facility Name
Bekes Megyei Pandy Kalman Korhaz
City
Gyula
Country
Hungary
Facility Name
Felnott Haziorvosi Rendelo
City
Kecskemet
Country
Hungary
Facility Name
Haziorvosi Rendelo
City
Kecskemet
Country
Hungary
Facility Name
Felnott Haziorvosi Rendelo
City
Miskolc
Country
Hungary
Facility Name
Revamed Kft.
City
Nyiregyhaza
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Szekesfehervar
Country
Hungary
Facility Name
Liga Kozlovska Family Doctor Practice
City
Balvi
Country
Latvia
Facility Name
Jelgava Outpatient Clinic
City
Jelgava
Country
Latvia
Facility Name
Dr. R. Eglite's Private Practice
City
Kuldiga
Country
Latvia
Facility Name
Dr. Dz.Trosk's practice
City
Lielvarde
Country
Latvia
Facility Name
Regional Hospital of Liepaja
City
Liepaja
Country
Latvia
Facility Name
Hospital of Reseknes
City
Rezekne
Country
Latvia
Facility Name
Clinic of GP A.Lasmanis "ALMA"
City
Riga
Country
Latvia
Facility Name
Vecverdina Vizma - GP Practice
City
Riga
Country
Latvia
Facility Name
Centro de Investigacion Clinica Acelerada, S.C.
City
Mexico
State/Province
Distrito Federal
Country
Mexico
Facility Name
Centro de Investigacion Clinica GRAMEL S.C
City
Mexico
State/Province
Distrito Federal
Country
Mexico
Facility Name
Facultad Mexicana de Medicina, Universidad La Salle A.C.
City
Mexico
State/Province
Distrito Federal
Country
Mexico
Facility Name
Hospital Angeles Lindavista
City
Mexico
State/Province
Distrito Federal
Country
Mexico
Facility Name
Mexico Centre for Clinical Research S.A. de C.V
City
Mexico
State/Province
Distrito Federal
Country
Mexico
Facility Name
Phylasis Clinicas Research S de RL de CV
City
Cuautitlan Izcalli
State/Province
Estado De Mexico
Country
Mexico
Facility Name
Clinical Research Institute S.C.
City
Tlalnepantla
State/Province
Estado De Mexico
Country
Mexico
Facility Name
Centro de Investigacion Medico Biologica y Terapia Avanzada (CIMBYTA)
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Hospital de Especialidades Centro Medico Puerta de Hierro
City
Zapopan
State/Province
Jalisco
Country
Mexico
Facility Name
Centro de Investigaction y Transferencia en Salud del Tecnologico de Monterrey
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Hospital Universitario de Monterrey
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Nucleo Victoria de Investigacion Clinica S.C.
City
Durango
Country
Mexico
Facility Name
Oaxaca Site Management Organization S.C.
City
Oaxaca
Country
Mexico
Facility Name
Optimal Clinical Trials
City
Auckland
Country
New Zealand
Facility Name
Primorus Clinical Trials Ltd
City
Christchurch
Country
New Zealand
Facility Name
Shirley Medical Centre
City
Christchurch
Country
New Zealand
Facility Name
Clinical Trials New Zealand Ltd
City
Hamilton
Country
New Zealand
Facility Name
Auckland Family Medical Centre
City
Remuera
Country
New Zealand
Facility Name
Hospital Nacional Carlos Alberto Seguin Escobedo
City
Arequipa
Country
Peru
Facility Name
Hospital Nacional Adolfo Guevara Velasco
City
Cusco
Country
Peru
Facility Name
Clinica Internacional Sede San Borja
City
Lima
Country
Peru
Facility Name
Clinica San Borja
City
Lima
Country
Peru
Facility Name
Hospital Maria Auxiliadora
City
Lima
Country
Peru
Facility Name
Hospital Nacional Arzobispo Loayza
City
Lima
Country
Peru
Facility Name
Global Clinical Trials PE
City
Port Elizabeth
State/Province
Eastern Cape
Country
South Africa
Facility Name
Iatros International
City
Bloemfontein
State/Province
Free State
Country
South Africa
Facility Name
Josha Research
City
Bloemfontein
State/Province
Free State
Country
South Africa
Facility Name
Drs YAK Vahed and Partners
City
Welkom
State/Province
Free State
Country
South Africa
Facility Name
Maphutha, MB
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Medicross Roodepoort Clinical Research
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Clinresco Centres (Pty) Ltd
City
Kempton Park
State/Province
Gauteng
Country
South Africa
Facility Name
DJW Research
City
Krugersdorp
State/Province
Gauteng
Country
South Africa
Facility Name
Synexus SA, Stanza Bopape Clinical Research Centre
City
Mamelodi East
State/Province
Gauteng
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Engelbrecht, I
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Global Clinical Trials Pretoria
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Jongaie Research
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Synexus SA - Watermeyer Clinical Research Centre
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Syzygy Clinical Research Services Wilgers
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
University of Pretoria Clinical Research Unit
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
De Villiers Clinical Trials
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Sebastian, Peter
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Synapta Clinical Research
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
van Rensburg, CJJ
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Vawda, ZFA
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Brookdale Clinical Research Centre
City
Phoenix
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Richards Bay Trial Centre (Pty) Ltd
City
Richards Bay
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Aliwal Shoal Medical Centre
City
Umkomaas
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Limpopo Clinical Research Initiative
City
Thabazimbi
State/Province
Limpopo
Country
South Africa
Facility Name
Mzansi Ethical Research Centre
City
Middelburg
State/Province
Mpumalanga
Country
South Africa
Facility Name
Africa International Research
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Allergy Diagnostic & Clinical Research Unit
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Boyd, WV
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Helderberg Clinical Trials Centre
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Langeberg Clinical Trials
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Tiervlei Trial Centre
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Western Cape Clinical Trials
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Excellentis Clinical Trial Consultants
City
George
State/Province
Western Cape
Country
South Africa
Facility Name
Somerset West Clinical Trial Unit
City
Somerset West
State/Province
Western Cape
Country
South Africa
Facility Name
Clinical Projects Research SA (PTY) LTD
City
Worcester
State/Province
Western Cape
Country
South Africa
Facility Name
Staploe Medical Centre
City
Ely
State/Province
Cambridgeshire
Country
United Kingdom
Facility Name
Avondale Surgery Research
City
Chesterfield
State/Province
Derbyshire
Country
United Kingdom
Facility Name
Knowle House Surgery
City
Plymouth
State/Province
Devon
Country
United Kingdom
Facility Name
Sheepcot Medical Centre
City
Watford
State/Province
Hertfordshire
Country
United Kingdom
Facility Name
CPS Ltd
City
Glasgow
State/Province
Strathclyde
Country
United Kingdom
Facility Name
Holbrook Lane Surgery
City
Coventry
State/Province
Warwickshire
Country
United Kingdom
Facility Name
Bradford on Avon Health Centre
City
Bradford-on-Avon
State/Province
Wiltshire
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza

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