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InfluenzaPhase 2IglooNCT01793883

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

A Phase 2 study testing 40 mg Laninamivir Octanoate and 80 mg Laninamivir Octanoate in people with Influenza, run by Biota Scientific Management Pty Ltd at 221 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Influenza
What is being tested?
40 mg Laninamivir Octanoate and 80 mg Laninamivir Octanoate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
639 participants
Where
221 sitesin 16 countries
Study dates
May 2013to May 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

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:
  4. 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
  5. ≥1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) AND
  6. ≥1 moderate respiratory symptom (cough, sore throat and nasal congestion)
  7. 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:
  8. time when the subjects' temperature was measured as elevated (≥38.0°C (≥100.4ºF) OR
  9. time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion) OR
  10. 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

Trial locations and contacts

221 sites in 16 countries.

221 sites in 16 countries

United States70 sites

  • Paul Shapero, MD

    Bangor, Maine, 04401

  • Pioneer Clinical Research, LLC

    Bellevue, Nebraska, 68005

  • The Asthma & Allergy Center, P.C. master

    Bellevue, Nebraska, 68123-4303

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Bethesda Allergy, Asthma & Research Center, LLC

    Bethesda, Maryland, 20814

  • BRCR Medical Center, Inc DBA Boca Raton Clinical Research

    Boca Raton, Florida, 33432

  • Zasa Clinical Research, LLC

    Boynton Beach, Florida, 33437

  • Clinical Trial Connection

    Camp Verde, Arizona, 86322

  • Warner Family Practice

    Chandler, Arizona, 85224

  • Southeast Clinical Research, LLC

    Chiefland, Florida, 32626

  • eStudySite

    Chula Vista, California, 91911

  • Sentral Clinical Research Services, LLC

    Cincinnati, Ohio, 45236

  • Westside Medical

    Clinton, Utah, 84015

  • Clinical Research Solutions, PC

    Columbia, Tennessee, 38401

  • Sanitas Research

    Coral Gables, Florida, 33134

  • Focus Clinical Research

    Draper, Utah, 84020

  • Neccr Imca, Llc

    Fall River, Massachusetts, 02720

  • HCCA Clinical Research Solutions

    Franklin, Tennessee, 37067

  • Clinical Research Solutions, PC

    Franklin, Tennessee, 37604

  • Beacom Family Health Connection

    Fremont, Nebraska, 68025

  • Clinical Research Connections, LLC

    Harrisburg, Arkansas, 72432

  • PMG Research of Hickory, LLC

    Hickory, North Carolina, 28602

  • Beach Physicians Medical Group, Inc.

    Huntington Beach, California, 92647

  • Women's Healthcare Associates P.A.

    Idaho Falls, Idaho, 83404

  • HCCA Clinical Research Solutions

    Jackson, Tennessee, 38305

  • Southeast Clinical Research, LLC - Parent

    Jacksonville, Florida, 32216

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • PMG Research of Knoxville

    Knoxville, Tennessee, 37912

  • eStudySite

    La Mesa, California, 91942

  • Detweiler Family Medicine & Associates

    Lansdale, Pennsylvania, 19446

  • eStudySite

    Las Vegas, Nevada, 89109

  • Novo Research, Inc.

    Long Beach, California, 90813-3296

  • Baptist Health Clinical Studies

    Madisonville, Kentucky, 42431-1665

  • Clinical Trials Management, LLC

    Mandeville, Louisiana, 70471

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006

  • Medipharmics, LLC

    Metairie, Louisiana, 70006

  • Columbus Clinical Services, LLC

    Miami, Florida, 33174

  • New Horizon Research Center, Inc

    Miami, Florida, 33175

  • Crystal Biomedical Research

    Miami Lakes, Florida, 33014

  • Hometown Urgent Care & Occupational Health

    Milford, Ohio, 45150

  • Clinical Research Solutions, PC

    Nashville, Tennessee, 37211

  • KAMP Medical Research

    Natchitoches, Louisiana, 71457

  • Complete Family Care

    Northglenn, Colorado, 80234

  • Lucita M. Cruz, MD, Inc

    Norwalk, California, 90650

  • eStudySite

    Oceanside, California, 92056

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654

  • Clinical Trials of Orange County, Inc

    Orange, California, 92868

  • DCT - FMC, LLC, d/b/a Discovery Clinical Trials

    Orlando, Florida, 32806

  • ACRC Trials

    Plano, Texas, 75024

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • Carilion Infectious Disease

    Roanoke, Virginia, 24014

  • J. Lewis Research - FirstMed East

    Salt Lake City, Utah, 84121

  • Sun Research Institute, LLC

    San Antonio, Texas, 78215

  • Oakwell Clinical Research

    San Antonio, Texas, 78218

  • DBA Southwest Clinic

    San Antonio, Texas, 78221-1615

  • DCT-Stone Oak, LLC dba Discovery Clinical Trials

    San Antonio, Texas, 78258

  • California Research Foundation

    San Diego, California, 92103-6204

  • San Diego Sports Medicine & Family Health Center

    San Diego, California, 92120

  • Scottsboro Quick Care Clinic

    Scottsboro, Alabama, 35768

  • Hillcrest Clinical Research, LLC

    Simpsonville, South Carolina, 29681

  • Clinical Research Solutions, PC

    Smyrna, Tennessee, 37167

  • Dr. B. Abraham, PC

    Snellville, Georgia, 30039

  • ProMedica Health System, Inc

    Sylvania, Ohio, 43560

  • Oakland Medical Research Center

    Troy, Michigan, 48085

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma, 74136

  • Orange County Research Center, Inc

    Tustin, California, 92780

  • SC Clinical Research, Inc.

    Upland, California, 91786

  • Warminster Medical Associates, PC

    Warminster, Pennsylvania, 18974

  • AAPRI Clinical Research Institute

    Warwick, Rhode Island, 02886

  • University of Massachusetts Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

South Africa36 sites

  • Iatros International

    Bloemfontein, Free State

  • Josha Research

    Bloemfontein, Free State

  • Africa International Research

    Cape Town, Western Cape

  • Allergy Diagnostic & Clinical Research Unit

    Cape Town, Western Cape

  • Boyd, WV

    Cape Town, Western Cape

  • Helderberg Clinical Trials Centre

    Cape Town, Western Cape

  • Langeberg Clinical Trials

    Cape Town, Western Cape

  • Tiervlei Trial Centre

    Cape Town, Western Cape

  • Western Cape Clinical Trials

    Cape Town, Western Cape

  • De Villiers Clinical Trials

    Durban, KwaZulu-Natal

  • Sebastian, Peter

    Durban, KwaZulu-Natal

  • Synapta Clinical Research

    Durban, KwaZulu-Natal

  • van Rensburg, CJJ

    Durban, KwaZulu-Natal

  • Vawda, ZFA

    Durban, KwaZulu-Natal

  • Aliwal Shoal Medical Centre

    eMkhomazi, KwaZulu-Natal

  • Excellentis Clinical Trial Consultants

    George, Western Cape

  • Maphutha, MB

    Johannesburg, Gauteng

  • Medicross Roodepoort Clinical Research

    Johannesburg, Gauteng

  • Clinresco Centres (Pty) Ltd

    Kempton Park, Gauteng

  • DJW Research

    Krugersdorp, Gauteng

  • Synexus SA, Stanza Bopape Clinical Research Centre

    Mamelodi East, Gauteng

  • Mzansi Ethical Research Centre

    Middelburg, Mpumalanga

  • Brookdale Clinical Research Centre

    Phoenix, KwaZulu-Natal

  • Global Clinical Trials PE

    Port Elizabeth, Eastern Cape

  • Emmed Research

    Pretoria, Gauteng

  • Engelbrecht, I

    Pretoria, Gauteng

  • Global Clinical Trials Pretoria

    Pretoria, Gauteng

  • Jongaie Research

    Pretoria, Gauteng

  • Synexus SA - Watermeyer Clinical Research Centre

    Pretoria, Gauteng

  • Syzygy Clinical Research Services Wilgers

    Pretoria, Gauteng

  • University of Pretoria Clinical Research Unit

    Pretoria, Gauteng

  • Richards Bay Trial Centre (Pty) Ltd

    Richards Bay, KwaZulu-Natal

  • Somerset West Clinical Trial Unit

    Somerset West, Western Cape

  • Limpopo Clinical Research Initiative

    Thabazimbi, Limpopo

  • Drs YAK Vahed and Partners

    Welkom, Free State

  • Clinical Projects Research SA (PTY) LTD

    Worcester, Western Cape

Other trials in South Africa

Mexico13 sites

  • Phylasis Clinicas Research S de RL de CV

    Cuautitlán Izcalli, State of Mexico

  • Nucleo Victoria de Investigacion Clinica S.C.

    Durango

  • Centro de Investigacion Medico Biologica y Terapia Avanzada (CIMBYTA)

    Guadalajara, Jalisco

  • Centro de Investigacion Clinica Acelerada, S.C.

    Mexico City, Mexico City

  • Centro de Investigacion Clinica GRAMEL S.C

    Mexico City, Mexico City

  • Facultad Mexicana de Medicina, Universidad La Salle A.C.

    Mexico City, Mexico City

  • Hospital Angeles Lindavista

    Mexico City, Mexico City

  • Mexico Centre for Clinical Research S.A. de C.V

    Mexico City, Mexico City

  • Centro de Investigaction y Transferencia en Salud del Tecnologico de Monterrey

    Monterrey, Nuevo León

  • Hospital Universitario de Monterrey

    Monterrey, Nuevo León

  • Oaxaca Site Management Organization S.C.

    Oaxaca City

  • Clinical Research Institute S.C.

    Tlalnepantla, State of Mexico

  • Hospital de Especialidades Centro Medico Puerta de Hierro

    Zapopan, Jalisco

Other trials in Mexico

Germany11 sites

  • Gemeinschaftspraxis Dr. med. Reinhold Jerwan-Keim, Renate Metz

    Dietzenbach, Hesse

  • ABX-CRO advanced pharmaceuticals Forschungsqesellschaft mbH

    Dresden, Saxony

  • Gemeinschaftspraxis Dres. Hagemann, Duerfeld und Breiderhoff

    Essen, North Rhine-Westphalia

  • Hausarztzentrum Bocholder Strasse

    Essen, North Rhine-Westphalia

  • Medizentrum Essen Borbeck

    Essen, North Rhine-Westphalia

  • Unterfrintroper Hausarztzentrum

    Essen, North Rhine-Westphalia

  • Institut fuer Praeventive Medizin Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg

  • medicoKIT

    Goch, North Rhine-Westphalia

  • Praxis Dr. Schiewe

    Hamburg

  • Gemeinschaftspraxis Heisters und Sungen

    Kamp-Lintfort, North Rhine-Westphalia

  • Gemeinschaftspraxis Dres. Kleinecke-Pohl, Kirsch, Benner-Hemsen

    Koein, North Rhine-Westphalia

Other trials in Germany

Hungary11 sites

  • Clinexpert Egeszsegugyi Szolg. es Ker. Kft.

    Budapest

  • CSALADGYOGYYASZ Szolgaltato es Oktato Bt.

    Budapest

  • Haziorvosi Rendelo

    Budapest

  • QUALICLINIC Eu-i Szolg. es Kutatasszervezo Kft

    Budapest

  • Kenezy Korhaz es Rendelointezet

    Debrecen

  • Bekes Megyei Pandy Kalman Korhaz

    Gyula

  • Felnott Haziorvosi Rendelo

    Kecskemét

  • Haziorvosi Rendelo

    Kecskemét

  • Felnott Haziorvosi Rendelo

    Miskolc

  • Revamed Kft.

    Nyíregyháza

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár

Other trials in Hungary

Australia10 sites

  • Pain & Anaesthesia Research Clinic

    Adelaide, South Australia

  • Hunter Clinical Research

    Broadmeadows, Victoria

  • Dr Doong's Surgery

    Burwood, New South Wales

  • Cairns Base Hospital

    Cairns, Queensland

  • Jimboomba Junction Family Practice & Skin Cancer Clinic

    Jimboomba, Queensland

  • Mermaid Beach Medical Centre

    Mermaid Beach, Queensland

  • Morayfield 7 Day Medical Centre

    Morayfield, Queensland

  • AusTrials Pty Ltd. Sherwood

    Sherwood, Queensland

  • Hyde Park Medical

    Sydney, New South Wales

  • Westmead Hospital

    Wentworthville, New South Wales

Other trials in Australia

Bulgaria10 sites

  • SHATPPD-Ruse EOOD

    Rousse

  • DCARC "Hill Clinic"

    Sofia

  • Diagnostic Consultative Center II - Sofia OOD

    Sofia

  • Fifth MHAT-Sofia, EAD

    Sofia

  • MHAT "Lyulin", EAD

    Sofia

  • Military Medical Academy - MHAT - Sofia

    Sofia

  • NMTH "Tsar Boris III"

    Sofia

  • UMHAT " Alexandrovska" EAD

    Sofia

  • UMHAT 'Lozenets"

    Sofia

  • MDHAT Dr Stefan Cherkezov, AD

    Veliko Tarnovo

Other trials in Bulgaria

Belgium9 sites

  • Dokter Luc Timmermans

    Borgerhout

  • Vereecken Guy

    Halen

  • Calozet, Yven

    Herbeumont

  • Hutsebaut, Andre

    Moerkerke

  • Van Mulders, Norbert

    Moorsel

  • Parque, Jean-Luc

    Mouscron

  • Mortelmans, Jaak

    Oostham

  • Private Practice

    Oudenaarde

  • BVBA Dr. Luc Capiau

    Wetteren

Other trials in Belgium

Estonia9 sites

  • Vee Family Doctor's Center OY

    Paide

  • Medicum Perearstikeskus AS

    Tallinn

  • Meie Tervis OU

    Tallinn

  • Merekivi Perearstid OU

    Tallinn

  • Merelahe Family Doctors Centre

    Tallinn

  • Mustamae Health Centre

    Tallinn

  • Pirita Family Doctors Centre

    Tallinn

  • Dr Monika Vask Ltd.

    Tartu

  • Marje Toom Family Doctors Practice

    Võru

Other trials in Estonia

France8 sites

  • Cabinet Medical

    Briollay, Maine Et Loire

  • Cabinet Medical

    La Bouëxière, Ille Et Vilaine

  • Cabinet Medical

    La Montagne, Loire Atlantique

  • Cabinet Medical Jacques Marty

    Mûrs-Erigné, Maine Et Loire

  • Cabinet Medical - Alain Boye

    Nantes, Loire Atlantique

  • Cabinet Medical Jean Charcot

    Segré, Maine Et Loire

  • Cabinet Medical

    Tours, Indre Et Loire

  • Cabinet Medical

    Vihiers

Other trials in France

Latvia8 sites

  • Liga Kozlovska Family Doctor Practice

    Balvi

  • Jelgava Outpatient Clinic

    Jelgava

  • Dr. R. Eglite's Private Practice

    Kuldīga

  • Dr. Dz.Trosk's practice

    Lielvārde

  • Regional Hospital of Liepaja

    Liepāja

  • Hospital of Reseknes

    Rēzekne

  • Clinic of GP A.Lasmanis "ALMA"

    Riga

  • Vecverdina Vizma - GP Practice

    Riga

Other trials in Latvia

United Kingdom7 sites

  • Bradford on Avon Health Centre

    Bradford on Avon, Wiltshire

  • Avondale Surgery Research

    Chesterfield, Derbyshire

  • Holbrook Lane Surgery

    Coventry, Warwickshire

  • Staploe Medical Centre

    Ely, Cambridgeshire

  • CPS Ltd

    Glasgow, Strathclyde

  • Knowle House Surgery

    Plymouth, Devon

  • Sheepcot Medical Centre

    Watford, Hertfordshire

Other trials in United Kingdom

Peru6 sites

  • Hospital Nacional Carlos Alberto Seguin Escobedo

    Arequipa

  • Hospital Nacional Adolfo Guevara Velasco

    Cusco

  • Clinica Internacional Sede San Borja

    Lima

  • Clinica San Borja

    Lima

  • Hospital Maria Auxiliadora

    Lima

  • Hospital Nacional Arzobispo Loayza

    Lima

Other trials in Peru

Canada5 sites

  • Aggarwal and Associates Ltd

    Brampton, Ontario

  • Dr. Anil K. Gupta Medicine Professional Corporation

    Etobicoke, Ontario

  • Omnispec Clinical Research Inc

    Mirabel, Quebec

  • SKDS Research Inc.

    Newmarket, Ontario

  • Clinique Medicale St-Louis (Recherche) Inc

    Québec

Other trials in Canada

New Zealand5 sites

  • Optimal Clinical Trials

    Auckland

  • Primorus Clinical Trials Ltd

    Christchurch

  • Shirley Medical Centre

    Christchurch

  • Clinical Trials New Zealand Ltd

    Hamilton

  • Auckland Family Medical Centre

    Remuera

Other trials in New Zealand

Colombia3 sites

  • Administradora Country S.A.

    Bogotá

  • Centro de Investigacion Clinica - CAFAM

    Bogotá

  • Clinica Colsanitas S.A. sede Clinica Universitaria Columbia

    Bogotá

Other trials in Colombia

About this study

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

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.

Read the 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.

Conditions
Influenza
Being tested
40 mg Laninamivir Octanoate, 80 mg Laninamivir Octanoate, Placebo
Keywords
Influenza Laninamivir Octanoate
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 40 mg Laninamivir OctanoateDrug

    Also called CS-8958

  • 80 mg Laninamivir OctanoateDrug

    Also called CS-8958

  • PlaceboDrug

    Also called Lactose

Study groups in NCT01793883
Study groupRoleWhat they receive
40 mg Laninamivir Octanoate DPIActive comparator40 mg Laninamivir Octanoate and matching placebo
Receives: Drug: 40 mg Laninamivir Octanoate; Drug: Placebo
80 mg Laninamivir Octanoate DPIActive comparator80 mg Laninamivir
Receives: Drug: 80 mg Laninamivir Octanoate
PlaceboPlacebo comparatorMatching Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Efficacy will be assessed over 14 days post-randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
639 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01793883
Sponsor's protocol ID
BTA51-350-201
Other IDs
HHSO100201100019C, 2013-000582-36
Acronym
Igloo
Status last verified
May 2018
First submitted
13 Feb 2013
Last updated
31 May 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 40 mg Laninamivir Octanoate and 80 mg Laninamivir Octanoate in people with Influenza, run by Biota Scientific Management Pty Ltd at 221 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 221 sites in United States, South Africa, Mexico, Germany, Hungary and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Alleviation of Influenza Symptoms (time frame: Efficacy will be assessed over 14 days post-randomization.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01793883.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.

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