Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00312806




Registration number
NCT00312806
Ethics application status
Date submitted
10/04/2006
Date registered
11/04/2006
Date last updated
7/05/2012

Titles & IDs
Public title
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
Scientific title
Real Life: Treatment Response in Patients With Symptoms Due to Gastroesophageal Reflux Disease Either With or Without Esophagitis Treated With Pantoprazole Sodium 40 mg o.d. Over 8 Weeks
Secondary ID [1] 0 0
BY1023/M3-341
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux Disease (GERD) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pantoprazole

Treatment: Drugs: Pantoprazole
Pantoprazole 40 mg o.d.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™
Timepoint [1] 0 0
4 and 8 weeks
Secondary outcome [2] 0 0
Investigator assessment
Timepoint [2] 0 0
4 and 8 weeks
Secondary outcome [3] 0 0
Safety and efficacy
Timepoint [3] 0 0
4 and 8 weeks

Eligibility
Key inclusion criteria
Main

* Written informed consent
* Outpatients of at least 18 years (21 years in Argentina)
* Patient considered to have GERD symptoms

Main
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Acute peptic ulcer and/or ulcer complications
* Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) during the last 28 days before study start (except regular intake of acetylsalicylic acid at a dose up to 163 mg/day)
* Intake of proton pump inhibitors during the last 10 days before study start
* Female patients of childbearing potential not using adequate means of birth control
* Pregnant or breast-feeding females

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2007
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Altana Pharma/Nycomed - Bedford Park SA
Recruitment hospital [2] 0 0
Altana Pharma/Nycomed - Bondi Junction
Recruitment hospital [3] 0 0
Altana Pharma/Nycomed - Fitzroy
Recruitment hospital [4] 0 0
Altana Pharma/Nycomed - Footscray
Recruitment hospital [5] 0 0
Altana Pharma/Nycomed - Fremantle, WA
Recruitment hospital [6] 0 0
Altana Pharma/Nycomed - Kippa_ring
Recruitment hospital [7] 0 0
Altana Pharma/Nycomed - Melbourne
Recruitment hospital [8] 0 0
Altana Pharma/Nycomed - NSW
Recruitment hospital [9] 0 0
Altana Pharma/Nycomed - Penrith, NSW
Recruitment hospital [10] 0 0
Altana Pharma/Nycomed - Phrahran
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park SA
Recruitment postcode(s) [2] 0 0
NSW 2022 - Bondi Junction
Recruitment postcode(s) [3] 0 0
VIC 3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
VIC 3011 - Footscray
Recruitment postcode(s) [5] 0 0
6959 - Fremantle, WA
Recruitment postcode(s) [6] 0 0
QLD 4021 - Kippa_ring
Recruitment postcode(s) [7] 0 0
VIC 3050 - Melbourne
Recruitment postcode(s) [8] 0 0
2310 - NSW
Recruitment postcode(s) [9] 0 0
- Penrith, NSW
Recruitment postcode(s) [10] 0 0
VIC 3181 - Phrahran
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
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Argentina
State/province [2] 0 0
La Plata
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Austria
State/province [3] 0 0
Deutschlandsberg
Country [4] 0 0
Austria
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Feldbach
Country [5] 0 0
Austria
State/province [5] 0 0
Graz
Country [6] 0 0
Austria
State/province [6] 0 0
Krems a. d. Donau
Country [7] 0 0
Austria
State/province [7] 0 0
Lilienfeld
Country [8] 0 0
Austria
State/province [8] 0 0
St. Pölten
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
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Belgium
State/province [10] 0 0
Bouge
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Belgium
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Brussels
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Belgium
State/province [12] 0 0
Bruxelles
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Belgium
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Edegem
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Belgium
State/province [14] 0 0
Eupen
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Belgium
State/province [15] 0 0
Gent
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Belgium
State/province [16] 0 0
Jette
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Belgium
State/province [17] 0 0
Kortrijk
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Belgium
State/province [18] 0 0
Leuven
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Belgium
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Merksem
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Belgium
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Oostende
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Belgium
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Sart-Tilman/Liege 1
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Belgium
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St. Niklaas
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Brazil
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Belo Horizonte - Minas Gerais
Country [24] 0 0
Brazil
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Botucatu - SP CEP
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Brazil
State/province [25] 0 0
Campinas - Sao Paulo
Country [26] 0 0
Brazil
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Campinas /SP
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Brazil
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Curitiba-PR
Country [28] 0 0
Brazil
State/province [28] 0 0
Ilha do Fundao - Rio de Janeiro - RJ
Country [29] 0 0
Brazil
State/province [29] 0 0
Pinheiros Sao Paulo - SP
Country [30] 0 0
Brazil
State/province [30] 0 0
Porto Alegre - RS
Country [31] 0 0
Brazil
State/province [31] 0 0
Porto Alegre-RS
Country [32] 0 0
Brazil
State/province [32] 0 0
Porto Alegre
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Brazil
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Ribeirao Preto-SP
Country [34] 0 0
Canada
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Abbotsford, BC
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Canada
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Calgary
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Canada
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Hamilton
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Canada
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London
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Canada
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Montreal, QC
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Canada
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Montreal
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Canada
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Quebec
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Canada
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St.-Charles Borromee, QC
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Canada
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Ste Foy
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Canada
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Toronto
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Canada
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Windsor
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Canada
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Winnipeg
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France
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Agen
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France
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Bobigny
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France
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Hagondange
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France
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Joue les Tours
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Lamballe
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Marseille
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Metz
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France
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Orthez
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Saint-Mande
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France
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Toulouse
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France
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Toul
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France
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Troyes
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Germany
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Bonn
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Germany
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Burg
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Germany
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Gardelegen
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Germany
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Heilbronn
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Germany
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Hennef
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Germany
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Ludwigsburg
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Germany
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Lübeck
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Germany
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Magdeburg
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Germany
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Schwerin
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Hong Kong
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Hong Kong
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India
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Coimbatore
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India
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Hyderabad
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India
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Jaipur
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India
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Madurai
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India
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Mumbai
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India
State/province [73] 0 0
Mysore
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India
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Nagpur
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India
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Pune
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Italy
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Aviano (Pordenone)
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Italy
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Bari
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Italy
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Caserta
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Italy
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Catania
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Italy
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Genova
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Italy
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Italy
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Milano
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Italy
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Napoli
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Parma
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Italy
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Roma
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Italy
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Rozzano (Milano)
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Korea, Republic of
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Seoul
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Malaysia
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Kota Kinabalu, Sabah
Country [89] 0 0
Malaysia
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Kuala Lumpur
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Mexico
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Col Del Valle, México D.F.
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Mexico
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Col Héroes de Padierna, México D.F.
Country [92] 0 0
Mexico
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Col. Altavista,Tampico Tamaulipas,Mexico
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Mexico
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Col. Ex Hacienda Coapa Mexico D.F.
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Mexico
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Héroes de Padierna, México D.F.
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Mexico
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León, Guanajuato Mexico
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Mexico
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León, Guanajuato
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Mexico
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Lomas de Chapultepec, México D.F.
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Mexico
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México, D.F.
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Mexico
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Villahermosa, Tabasco
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Poland
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Bialystok
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Poland
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Katowice
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Poland
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Lodz
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Poland
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Warszawa
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Amadora
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Carnaxide
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Lisboa
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Santarém
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Setúbal
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Viana do Castelo
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Vila Nova de Gaia
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Singapore
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Amanzimtoti
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Berea, Durban
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Barcelona
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Cordoba
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Cádiz
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Granada
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Ribeira
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Spain
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Sevilla
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Switzerland
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Basel
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Switzerland
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Biasca
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Switzerland
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Biel/Bienne
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Switzerland
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Lausanne 11 VD
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Switzerland
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Liestal
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Switzerland
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Locarno, TI.
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Switzerland
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Luzern
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Switzerland
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Payerne
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Switzerland
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Thun
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Switzerland
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Zürich
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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United Kingdom
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Bath
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United Kingdom
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Blackpool
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United Kingdom
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Glasgow
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United Kingdom
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Middlesex
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Sheffield
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Trowbridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hans-Joachim Ulmer, MD
Address 0 0
Medical practice, D-71640 Ludwigsburg, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00312806