Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)

NCT ID: NCT00312806

Last Updated: 2012-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-07-31

Brief Summary

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The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease (GERD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pantoprazole

Pantoprazole 40 mg o.d.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Nycomed

Principal Investigators

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Hans-Joachim Ulmer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical practice, D-71640 Ludwigsburg, Germany

Locations

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Altana Pharma/Nycomed

Buenos Aires, , Argentina

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Altana Pharma/Nycomed

Buenos Aires, , Argentina

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Altana Pharma/Nycomed

Buenos Aires, , Argentina

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Altana Pharma/Nycomed

La Plata, , Argentina

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Altana Pharma/Nycomed

Bedford Park SA, , Australia

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Altana Pharma/Nycomed

Bondi Junction, , Australia

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Altana Pharma/Nycomed

Fitzroy, , Australia

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Altana Pharma/Nycomed

Footscray, , Australia

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Altana Pharma/Nycomed

Fremantle, WA, , Australia

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Altana Pharma/Nycomed

Kippa_ring, , Australia

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Altana Pharma/Nycomed

Melbourne, , Australia

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Altana Pharma/Nycomed

NSW, , Australia

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Altana Pharma/Nycomed

Penrith, NSW, , Australia

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Altana Pharma/Nycomed

Phrahran, , Australia

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Altana Pharma/Nycomed

Deutschlandsberg, , Austria

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Altana Pharma/Nycomed

Feldbach, , Austria

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Altana Pharma/Nycomed

Graz, , Austria

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Altana Pharma/Nycomed

Krems A. D. Donau, , Austria

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Altana Pharma/Nycomed

Lilienfeld, , Austria

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Altana Pharma/Nycomed

Sankt Pölten, , Austria

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Altana Pharma/Nycomed

Vienna, , Austria

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Altana Pharma/Nycomed

Vienna, , Austria

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Vienna, , Austria

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Altana Pharma/Nycomed

Vienna, , Austria

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Altana Pharma/Nycomed

Vienna, , Austria

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Altana Pharma/Nycomed

Vienna, , Austria

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Altana Pharma/Nycomed

Bouge, , Belgium

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Altana Pharma/Nycomed

Brussels, , Belgium

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Altana Pharma/Nycomed

Brussels, , Belgium

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Altana Pharma/Nycomed

Brussels, , Belgium

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Altana Pharma/Nycomed

Brussels, , Belgium

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Altana Pharma/Nycomed

Edegem, , Belgium

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Altana Pharma/Nycomed

Eupen, , Belgium

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Altana Pharma/Nycomed

Ghent, , Belgium

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Altana Pharma/Nycomed

Jette, , Belgium

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Kortrijk, , Belgium

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Altana Pharma/Nycomed

Leuven, , Belgium

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Altana Pharma/Nycomed

Merksem, , Belgium

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Altana Pharma/Nycomed

Ostend, , Belgium

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Altana Pharma/Nycomed

Saint Niklaas, , Belgium

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Altana Pharma/Nycomed

Sart-Tilman/Liege 1, , Belgium

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Altana Pharma/Nycomed

Belo Horizonte - Minas Gerais, , Brazil

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Altana Pharma/Nycomed

Botucatu - SP CEP, , Brazil

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Campinas - Sao Paulo, , Brazil

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Campinas /SP, , Brazil

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Curitiba-PR, , Brazil

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Ilha Do Fundao - Rio de Janeiro - RJ, , Brazil

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Pinheiros Sao Paulo - SP, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre - RS, , Brazil

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Porto Alegre-RS, , Brazil

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Ribeirao Preto-SP, , Brazil

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Abbotsford, BC, , Canada

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Calgary, , Canada

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Hamilton, , Canada

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London, , Canada

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Montreal, , Canada

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Montreal, QC, , Canada

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Québec, , Canada

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St.-Charles Borromee, QC, , Canada

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Ste Foy, , Canada

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Toronto, , Canada

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Toronto, , Canada

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Windsor, , Canada

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Winnipeg, , Canada

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Agen, , France

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Bobigny, , France

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Hagondange, , France

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Joué-lès-Tours, , France

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Lamballe, , France

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Marseille, , France

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Metz, , France

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Orthez, , France

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Saint-Mandé, , France

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Toul, , France

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Toulouse, , France

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Troyes, , France

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Bonn, , Germany

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Burg, , Germany

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Gardelegen, , Germany

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Altana Pharma/Nycomed

Heilbronn, , Germany

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Altana Pharma/Nycomed

Hennef (Sieg), , Germany

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Altana Pharma/Nycomed

Ludwigsburg, , Germany

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Altana Pharma/Nycomed

Lübeck, , Germany

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Altana Pharma/Nycomed

Magdeburg, , Germany

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Schwerin, , Germany

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Hong Kong, , Hong Kong

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Coimbatore, , India

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Coimbatore, , India

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Hyderabad, , India

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Jaipur, , India

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Madurai, , India

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Mumbai, , India

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Mumbai, , India

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Mysore, , India

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Nagpur, , India

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Pune, , India

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Pune, , India

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Aviano (Pordenone), , Italy

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Bari, , Italy

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Caserta, , Italy

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Catania, , Italy

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Genova, , Italy

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Mestre (VE), , Italy

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Milan, , Italy

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Napoli, , Italy

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Parma, , Italy

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Roma, , Italy

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Roma, , Italy

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Roma, , Italy

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Rozzano (Milano), , Italy

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Kota Kinabalu, Sabah, , Malaysia

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Kuala Lumpur, , Malaysia

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Col Del Valle, México D.F., , Mexico

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Col Del Valle, México D.F., , Mexico

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Col Héroes de Padierna, México D.F., , Mexico

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Altana Pharma/Nycomed

Col. Altavista,Tampico Tamaulipas,Mexico, , Mexico

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Col. Ex Hacienda Coapa Mexico D.F., , Mexico

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Héroes de Padierna, México D.F., , Mexico

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León, Guanajuato Mexico, , Mexico

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León, Guanajuato, , Mexico

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Altana Pharma/Nycomed

Lomas de Chapultepec, México D.F., , Mexico

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México, D.F., , Mexico

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Villahermosa, Tabasco, , Mexico

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Villahermosa, Tabasco, , Mexico

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Bialystok, , Poland

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Katowice, , Poland

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Lodz, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Amadora, , Portugal

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Carnaxide, , Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Santarém, , Portugal

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Setúbal, , Portugal

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Viana do Castelo, , Portugal

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Vila Nova de Gaia, , Portugal

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Singapore, , Singapore

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Berea, Durban, , South Africa

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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eManzimtoti, , South Africa

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Panorama, , South Africa

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Port Elizabeth, , South Africa

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Pretoria, , South Africa

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Somerset West, , South Africa

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Barcelona, , Spain

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Barcelona, , Spain

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Cadiz, , Spain

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Castellon, , Spain

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Córdoba, , Spain

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Granada, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Pamplona, , Spain

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Ribeira, , Spain

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Seville, , Spain

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Basel, , Switzerland

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Biasca, , Switzerland

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Biel/Bienne, , Switzerland

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Lausanne 11 VD, , Switzerland

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Liestal, , Switzerland

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Locarno, TI., , Switzerland

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Lucerne, , Switzerland

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Payerne, , Switzerland

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Thun, , Switzerland

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Zurich, , Switzerland

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Altana Pharma/Nycomed

Zurich, , Switzerland

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Altana Pharma/Nycomed

Taichung, , Taiwan

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Altana Pharma/Nycomed

Tainan City, , Taiwan

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Altana Pharma/Nycomed

Taipei, , Taiwan

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Altana Pharma/Nycomed

Bath, , United Kingdom

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Altana Pharma/Nycomed

Blackpool, , United Kingdom

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Altana Pharma/Nycomed

Glasgow, , United Kingdom

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Altana Pharma/Nycomed

Middlesex, , United Kingdom

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Altana Pharma/Nycomed

Sheffield, , United Kingdom

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Altana Pharma/Nycomed

Trowbridge, , United Kingdom

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Countries

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Argentina Australia Austria Belgium Brazil Canada France Germany Hong Kong India Italy Malaysia Mexico Poland Portugal Singapore South Africa South Korea Spain Switzerland Taiwan United Kingdom

References

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Goh KL, Choi KD, Choi MG, Hsieh TY, Jung HY, Lien HC, Menon J, Mesenas S, Park H, Sheu BS, Wu JC. Factors influencing treatment outcome in patients with gastroesophageal reflux disease: outcome of a prospective pragmatic trial in Asian patients. BMC Gastroenterol. 2014 Sep 9;14:156. doi: 10.1186/1471-230X-14-156.

Reference Type DERIVED
PMID: 25200403 (View on PubMed)

Heading RC, Monnikes H, Tholen A, Schmitt H. Prediction of response to PPI therapy and factors influencing treatment outcome in patients with GORD: a prospective pragmatic trial using pantoprazole. BMC Gastroenterol. 2011 May 11;11:52. doi: 10.1186/1471-230X-11-52.

Reference Type DERIVED
PMID: 21569313 (View on PubMed)

Other Identifiers

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BY1023/M3-341

Identifier Type: -

Identifier Source: org_study_id

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