AzTrials
AzTrials

Chronic BronchitisPhase 4NCT00656747

Moxifloxacin Versus Amoxicillin Clavulanic Acid in Treatment of Acute Exacerbation of Chronic Bronchitis

A Phase 4 study testing Avelox (Moxifloxacin, BAY12-8039) and Amoxicillin clavulanic acid in people with Chronic Bronchitis, run by Bayer at 220 sites in 31 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

A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Chronic Bronchitis
What is being tested?
Avelox (Moxifloxacin, BAY12-8039) and Amoxicillin clavulanic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,372 participants
Where
220 sitesin 31 countries
Study dates
Mar 2008to Dec 2010
Phase
Phase 4
Are there results?
None posted in the registry

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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Outpatients with chronic bronchitis
  • Male or female subjects, >=60 years old
  • Post bronchodilator forced expiratory volume in one second (FEV1) less than or equal to 60% predicted and FEV1 / forced vital capacity (FVC) less than 70% at enrollment
  • Documented history of 2 or more AECB episodes, within 12 months of study enrollment, requiring a course of systemic antibiotics and/or systemic corticosteroids
  • All symptoms/signs must be present and confirmed by the Investigator:
  • increase in dyspnea
Show all 11Show fewer
  • purulent sputum
  • increase in sputum volume
  • Current or past cigarette smoker with equal to or greater than 20 pack year smoking history
  • Subjects must be exacerbation free for at least 30 days prior to enrollment
  • Subjects must be willing and able to complete the questionnaires and subject booklet without assistance

Who cannot join

  • Known hypersensitivity to quinolones, ß lactams, or to any of the excipients of the study drugs
  • Known to have congenital or acquired QT prolongation
  • Known to have clinically relevant bradycardia
  • Known to have clinically relevant heart failure with reduced left ventricular ejection fraction
  • Known to have previous history of symptomatic arrhythmias
  • Taking QT prolonging drugs, for example Class Ia or III antiarrhythmic agents or other QT prolonging drugs
Show all 23Show fewer
  • Known electrolyte disturbances that are not controlled, particularly uncorrected hypokalemia
  • Known history of hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose galactose malabsorption
  • History of a tendon disease/disorder
  • Known history of liver dysfunction (Child-Pugh C), including known elevated transaminase levels (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >5 times the upper limit of normal [5 x ULN])
  • Known severe renal impairment with glomerular filtration rate of <30 mL/min
  • Known neutropenia (neutrophil count <1000/mm3) caused by immunosuppressive therapy or malignancy
  • Known to have Acquired Immunodeficiency Syndrome (AIDS) (CD4 count of <200/mm3), or be human immunodeficiency virus (HIV) positive and receiving highly active anti retroviral therapy (HAART) (testing for HIV is not mandatory)
  • Known chronic asthma (>15% reversibility or at least 200 mL), bronchial carcinoma, active pulmonary tuberculosis, known diffuse bronchiectasis, cystic fibrosis, or pneumonia (a chest x ray is not mandatory)
  • Known history of chronic colonization of pathogenic organisms resistant to moxifloxacin and/or amoxicillin clavulanic acid (eg, P. aeruginosa, methicillin resistant Staphylococcus aureus)
  • Receiving long term (>4 consecutive weeks) systemic corticosteroid treatment (>10 mg/day of prednisolone or equivalent)
  • Received short course of systemic corticosteroid treatment within 30 days prior to enrollment
  • Life expectancy of less than 6 months
  • Receiving systemic antibacterial therapy within 30 days prior to study enrollment
  • Requiring concomitant systemic antibacterial agents
  • Requiring home ventilatory support (subjects requiring home/portable oxygen therapy or continuous positive airway pressure (CPAP) for sleep apnea are not excluded) and/or those who have a tracheotomy in situ
  • History of liver function disorders following previous treatment with amoxicillin-clavulanic acid
  • Receiving disulfiram therapy

Trial locations and contacts

220 sites in 31 countries.

220 sites in 31 countries

Germany29 sites

  • Study site

    Augsburg, Bavaria, 86150

  • Study site

    Bad Dürrheim, Baden-Wurttemberg, 78073

  • Study site

    Bad Segeberg, Schleswig-Holstein, 23795

  • Study site

    Berlin, State of Berlin, 10365

  • Study site

    Berlin, State of Berlin, 10717

  • Study site

    Berlin, State of Berlin, 10969

  • Study site

    Berlin, State of Berlin, 12043

  • Study site

    Berlin, State of Berlin, 12203

  • Study site

    Berlin, State of Berlin, 13597

  • Study site

    Berlin, State of Berlin, 14059

  • Study site

    Böhlen, Saxony, 04564

  • Study site

    Cottbus, Brandenburg, 03050

  • Study site

    Delitzsch, Saxony, 04509

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Frankfurt am Main, Hesse, 60318

  • Study site

    Frankfurt am Main, Hesse, 60389

  • Study site

    Fulda, Hesse, 36039

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20354

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 22305

  • Study site

    Leipzig, Saxony, 04207

  • Study site

    Leipzig, Saxony, 04275

  • Study site

    Leipzig, Saxony, 04357

  • Study site

    Lübeck, Schleswig-Holstein, 23552

  • Study site

    Lüdenscheid, North Rhine-Westphalia, 58515

  • Study site

    Meissen, Saxony, 01662

  • Study site

    Neubrandenburg, Mecklenburg-Vorpommern, 17033

  • Study site

    Neuwied, Rhineland-Palatinate, 56564

  • Study site

    Rüdersdorf, Brandenburg, 15562

  • Study site

    Zossen, Brandenburg, 15806

Other trials in Germany

Canada19 sites

  • Study site

    Antigonish Nova Scotia, Nova Scotia, B2G 2C2

  • Study site

    Burlington, Ontario, L7R 3X4

  • Study site

    Calgary, Alberta, T2N 4Z6

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Edmonton, Alberta, T6L 5X8

  • Study site

    Hamilton, Ontario, L8N 4A6

  • Study site

    Kelowna, British Columbia, V1Y 8E7

  • Study site

    London, Ontario, N6A 4V2

  • Study site

    London, Ontario, N6A 5G6

  • Study site

    Longueuil, Quebec, J4N 1E1

  • Study site

    Montreal, Quebec, H2L 4M1

  • Study site

    Saint John, New Brunswick, E2K 2T8

  • Study site

    Saint John, New Brunswick, E2M 3W5

  • Study site

    Sherbrooke, Quebec, JIH 4J6

  • Study site

    Sydney Mines, Nova Scotia, B1V 2Y5

  • Study site

    Toronto, Ontario, M6H 3M2

  • Study site

    Vancouver, British Columbia, V5Z 4E1

  • Study site

    Winnipeg, Manitoba, R3A 1R8

  • Study site

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

South Africa15 sites

  • Study site

    Benoni, Gauteng, 1500

  • Study site

    Bloemfontein, Freestate, 9324

  • Study site

    Cape Town, Western Cape, 7505

  • Study site

    Centurion, Gauteng, 0140

  • Study site

    Durban, KwaZulu-Natal, 4037

  • Study site

    Durban, KwaZulu-Natal, 4091

  • Study site

    Kempton Park, Gauteng, 1610

  • Study site

    Paarl, Western Cape, 7647

  • Study site

    Port Elizabeth, Eastern Cape, 6014

  • Study site

    Pretoria, Gauteng, 0002

  • Study site

    Pretoria, Gauteng, 0084

  • Study site

    Pretoria, Gauteng

  • Study site

    Somerset West, Western Cape, 7130

  • Study site

    Thabazimbi, Limpopo, 0380

  • Study site

    Witbank, Mpumalanga, 1035

Other trials in South Africa

China12 sites

  • Study site

    Beijing, 100020

  • Study site

    Beijing, 100050

  • Study site

    Changsha, Hunan, 410013

  • Study site

    Chengdu, Sichuan, 610041

  • Study site

    Guangzhou, Guangdong, 510120

  • Study site

    Guangzhou, Guangdong, 510405

  • Study site

    Shanghai, 200003

  • Study site

    Shanghai, 200040

  • Study site

    Shanghai, 200233

  • Study site

    Shengyang, Liaoning, 110004

  • Study site

    Shenyang, Liaoning, 110001

  • Study site

    Tianjin, 300052

Other trials in China

Switzerland10 sites

  • Study site

    Aarau, Canton of Aargau, 5000

  • Study site

    Basel, 4031

  • Study site

    Bern, Canton of Bern, 3004

  • Study site

    Binningen, Canton of Basel-City, 4102

  • Study site

    Laufen, Basel-Landschaft, 4242

  • Study site

    Oberwil, Basel-Landschaft, 4104

  • Study site

    Thun, 3600

  • Study site

    Wettingen, 5430

  • Study site

    Zurich, Canton of Zurich, 8048

  • Study site

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Argentina9 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, 1426

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1424BSF

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1425AWC

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires

  • Study site

    Quilmes, Buenos Aires

  • Study site

    San Juan Bautista, Buenos Aires

  • Study site

    San Miguel de Tucumán, Tucumán Province, 4000

  • Study site

    San Miguel de Tucumán, Tucumán Province

  • Study site

    Vicente López, 1638

Other trials in Argentina

Italy9 sites

  • Study site

    Ascoli Piceno, 63100

  • Study site

    Bussolengo, Verona, 37012

  • Study site

    Busto Arsizio, Varese, 21052

  • Study site

    Catania, 95122

  • Study site

    Chieti, 66100

  • Study site

    Milan, 20123

  • Study site

    Milan, 20157

  • Study site

    Perugia, 06156

  • Study site

    Pregiato Di Cava Dei Tirreni, Salerno, 84013

Other trials in Italy

Portugal9 sites

  • Study site

    Coimbra, Coimbra District, 3000-075

  • Study site

    Lisbon, 1169-024

  • Study site

    Lisbon, 1649-035

  • Study site

    Matosinhos Municipality, Porto District, 4454-509

  • Study site

    Porto, 4200

  • Study site

    S. Martinho Do Bispo, 3041-856

  • Study site

    Santarém, 2005-177

  • Study site

    Torres Vedras, Lisbon District, 2560-324

  • Study site

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

Belgium8 sites

  • Study site

    Aalst, 9300

  • Study site

    Antwerp, 2018

  • Study site

    Bruxelles - Brussel, 1020

  • Study site

    Halen, 3545

  • Study site

    Lommel, 3920

  • Study site

    Moerkerke, 8340

  • Study site

    Namur, 5000

  • Study site

    Yvoir, 5530

Other trials in Belgium

Spain8 sites

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, Barcelona, 08034

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Guadalajara, Guadalajara, 19002

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Palma de Mallorca, Illes Baleares, 07010

  • Study site

    Requena, Valencia, 46340

  • Study site

    Sant Boi de Llobregat, Barcelona, 08830

Other trials in Spain

Latvia7 sites

  • Study site

    Krāslava, 5601

  • Study site

    Riga, 1009

  • Study site

    Riga, 1011

  • Study site

    Riga, 1050

  • Study site

    Talsu, 3201

  • Study site

    Valmiera, 4201

  • Study site

    Ventspils, LV-3601

Other trials in Latvia

Mexico7 sites

  • Study site

    Chihuahua City, Chihuahua, 31350

  • Study site

    Guadalajara, Jalisco, 44280

  • Study site

    Huixquilucan, State of Mexico, CP 52763

  • Study site

    Mérida, Yucatán, 97001

  • Study site

    Monterrey, Nuevo León, 64718

  • Study site

    Monterrey, Nuevo León, 66480

  • Study site

    Zacatecas City, Zacatecas, 98608

Other trials in Mexico

Czechia6 sites

  • Study site

    Kyjov, 697 01

  • Study site

    Lovosice, 410 02

  • Study site

    Neratovice, 227 11

  • Study site

    Pardubice - Trnova, 530 09

  • Study site

    Praha - Malesice, 108 00

  • Study site

    Praha - Troja, 182 00

Other trials in Czechia

Lithuania6 sites

  • Study site

    Kaunas, LT-50425

  • Study site

    Kaunas

  • Study site

    Klaipėda, LT-94231

  • Study site

    Šiauliai, 76231

  • Study site

    Vilnius, LT-06122

  • Study site

    Vilnius, LT-07156

Other trials in Lithuania

Peru6 sites

  • Study site

    Callao, CALLAO 2

  • Study site

    Lima, Lima Province, LIMA 18

  • Study site

    Lima, 31

  • Study site

    Lima, 33

  • Study site

    Lima, LIMA 27

  • Study site

    Lima

Other trials in Peru

United Kingdom6 sites

  • Study site

    Coventry, Warwickshire, CV7 8LA

  • Study site

    Glasgow, Stratchclyde, G3 8YJ

  • Study site

    Glasgow, Stratchclyde, G45 9AW

  • Study site

    Glasgow, Stratchclyde, G46 8NY

  • Study site

    Glasgow, Stratchclyde, G69 7AD

  • Study site

    Glasgow, Stratchclyde

Other trials in United Kingdom

Australia5 sites

  • Study site

    Adelaide, South Australia, 5041

  • Study site

    Brisbane, Queensland, 4101

  • Study site

    Concord, New South Wales, 2139

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    Woodville, South Australia, 5011

Other trials in Australia

Colombia5 sites

  • Study site

    Bogotá

  • Study site

    Bucaramanga

  • Study site

    Cali, Cauca Department

  • Study site

    Cali

  • Study site

    Medellín

Other trials in Colombia

Greece5 sites

  • Study site

    Athens, Attica, 106 76

  • Study site

    Athens, 11527

  • Study site

    Ioannina, 45500

  • Study site

    Mezourlo, Larissa, 41110

  • Study site

    Rio, Patras, 265 04

Other trials in Greece

Ireland5 sites

  • Study site

    Bray, Wicklow

  • Study site

    Enniscorthy, Wexford

  • Study site

    Gorey, Wexford

  • Study site

    Killarney, Kerry

  • Study site

    Longford, Longford

Other trials in Ireland

Netherlands5 sites

  • Study site

    Eindhoven, North Brabant, 5623 EJ

  • Study site

    Heerlen, 6419 PC

  • Study site

    Hoofddorp, 2134 TM

  • Study site

    Meppel, 7943 KA

  • Study site

    Utrecht, 3582 KE

Other trials in Netherlands

Brazil4 sites

  • Study site

    Juiz de Fora, Minas Gerais, 36036-110

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    São Paulo, São Paulo, 04032-060

  • Study site

    São Paulo, São Paulo, 05403-900

Other trials in Brazil

Croatia4 sites

  • Study site

    Osijek, 310 00

  • Study site

    Petrinja, 44 250

  • Study site

    Rijeka, 510 00

  • Study site

    Zagreb, 10000

Other trials in Croatia

France4 sites

  • Study site

    Marseille, 13009

  • Study site

    Mont-de-Marsan, 40000

  • Study site

    Nice, 06000

  • Study site

    Perpignan, 66025

Other trials in France

Chile3 sites

  • Study site

    Santiago

  • Study site

    Valparaíso

  • Study site

    Viña del Mar

Other trials in Chile

Indonesia3 sites

  • Study site

    Bandung

  • Study site

    Jakarta, 13230

  • Study site

    Surabaya

Other trials in Indonesia

Pakistan3 sites

  • Study site

    Islamabad

  • Study site

    Karachi, Sindh, 74800

  • Study site

    Karachi, 75500

Other trials in Pakistan

Thailand3 sites

  • Study site

    Bangkok, 10330

  • Study site

    Chiang Mai, Thailand, 50200

  • Study site

    Nonthaburi, 11000

Other trials in Thailand

Hong Kong2 sites

  • Study site

    Hong Kong

  • Study site

    Kowloon

Other trials in Hong Kong

Philippines2 sites

  • Study site

    Manila

  • Study site

    Quezon City

Other trials in Philippines

Andorra1 site

  • Study site

    Les Escaldes

About this study

Official title: MAESTRAL - A Prospective, Multinational, Multicenter, Randomized, Double Blind, Double Dummy, Controlled Study Comparing the Efficacy and Safety of Moxifloxacin to That of Amoxicillin Clavulanic Acid for the Treatment of Subjects With Acute Exacerbations of Chronic Bronchitis.

A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis.

Being tested
Avelox (Moxifloxacin, BAY12-8039), Amoxicillin clavulanic acid
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Acute exacerbation of COPD (AECOPD), chronic bronchitis, bronchitis, chest infection, smoking, lung disease, lung, lungs
Medical subject headings
Bronchitis, Chronic, Pulmonary Disease, Chronic Obstructive, Bronchitis, Smoking, Lung Diseases

What participants receive

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

  • Avelox (Moxifloxacin, BAY12-8039)Drug

    Subjects will be randomised to moxifloxacin 400 mg PO OD (5 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.

  • Amoxicillin clavulanic acidDrug

    Subjects will be randomised to amoxicillin-clavulanic acid 875/125 mg PO BID (7 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.

Study groups in NCT00656747
Study groupRoleWhat they receive
Arm 2Active comparatorNot described
Receives: Drug: Amoxicillin clavulanic acid
Arm 1ExperimentalNot described
Receives: Drug: Avelox (Moxifloxacin, BAY12-8039)

What is being measured

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

  1. Clinical failure at 8 weeks post therapy

    Measured: At day 63

Secondary outcomes (13)

  1. Clinical failure rates

    Measured: Through to day 35

  2. Bacteriological eradication rates

    Measured: Through to day 63

  3. Clinical failure rates for subjects with positive sputum culture at enrollment

    Measured: Through to day 63

  4. Weekly mean symptom scores measured by the AECB SS

    Measured: Through to day 63

  5. Rates and speed of symptom relief measured by the AECB SS

    Measured: Through to day 63

  6. Clinical failure rates for subjects with co-administration of systemic corticosteroids (stratum 1)

    Measured: Through to day 63

  7. Clinical failure rates for subjects without co-administration of systemic corticosteroids (stratum 2)

    Measured: Through to day 63

  8. Need for any change in dosage or additional respiratory medication such as bronchodilators and inhaled steroids, excluding short acting bronchodilators

    Measured: Through to day 63

  9. Improvement in symptoms burden measured by the AECB SS

    Measured: Through to day 63

  10. Improvement in health related QoL measured by the SGRQ

    Measured: Through to day 63

  11. spirometry tests will be compared between treatment groups

    Measured: Through to day 63

  12. HCRU relat. to chronic bronchitis management incl. rescue med., concomitant med., therap. adjuncts, diagn. procedures, other medical care/medical staff requirement, hospitalizations (incl. ward and duration), and work productivity and activity impairment

    Measured: Through to day 63

  13. Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrhea

    Measured: Through to day 63

Timeline

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

  1. First posted11 Apr 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionDec 2010
  4. Study completionDec 2010

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00656747
Sponsor's protocol ID
11980
Other IDs
2007-006096-37
Status last verified
Nov 2014
First submitted
4 Apr 2008
Last updated
1 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Wilson R, Anzueto A, Miravitlles M, Arvis P, Farago G, Haverstock D, Trajanovic M, Sethi S. A novel study design for antibiotic trials in acute exacerbations of COPD: MAESTRAL methodology. Int J Chron Obstruct Pulmon Dis. 2011;6:373-83. doi: 10.2147/COPD.S21071. Epub 2011 Jun 29.

    PubMed 21760724

  • Wilson R, Anzueto A, Miravitlles M, Arvis P, Haverstock D, Trajanovic M, Sethi S. Prognostic factors for clinical failure of exacerbations in elderly outpatients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2015 Jun 2;10:985-93. doi: 10.2147/COPD.S80926. eCollection 2015.

    PubMed 26082623

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Avelox (Moxifloxacin, BAY12-8039) and Amoxicillin clavulanic acid in people with Chronic Bronchitis, run by Bayer at 220 sites in 31 countries.

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

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. 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 1 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 220 sites in Germany, Canada, South Africa, China, Switzerland and 26 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Clinical failure at 8 weeks post therapy (time frame: At day 63). 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 NCT00656747, which also lists 2 linked publications.

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 1 Dec 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in