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
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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COMPLETED
PHASE3
2000 participants
INTERVENTIONAL
2006-05-31
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Pantoprazole
Pantoprazole 40 mg o.d.
Eligibility Criteria
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Inclusion Criteria
* Outpatients of at least 18 years (21 years in Argentina)
* Patient considered to have GERD symptoms
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
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
Altana Pharma/Nycomed
Buenos Aires, , Argentina
Altana Pharma/Nycomed
Buenos Aires, , Argentina
Altana Pharma/Nycomed
La Plata, , Argentina
Altana Pharma/Nycomed
Bedford Park SA, , Australia
Altana Pharma/Nycomed
Bondi Junction, , Australia
Altana Pharma/Nycomed
Fitzroy, , Australia
Altana Pharma/Nycomed
Footscray, , Australia
Altana Pharma/Nycomed
Fremantle, WA, , Australia
Altana Pharma/Nycomed
Kippa_ring, , Australia
Altana Pharma/Nycomed
Melbourne, , Australia
Altana Pharma/Nycomed
NSW, , Australia
Altana Pharma/Nycomed
Penrith, NSW, , Australia
Altana Pharma/Nycomed
Phrahran, , Australia
Altana Pharma/Nycomed
Deutschlandsberg, , Austria
Altana Pharma/Nycomed
Feldbach, , Austria
Altana Pharma/Nycomed
Graz, , Austria
Altana Pharma/Nycomed
Krems A. D. Donau, , Austria
Altana Pharma/Nycomed
Lilienfeld, , Austria
Altana Pharma/Nycomed
Sankt Pölten, , Austria
Altana Pharma/Nycomed
Vienna, , Austria
Altana Pharma/Nycomed
Vienna, , Austria
Altana Pharma/Nycomed
Vienna, , Austria
Altana Pharma/Nycomed
Vienna, , Austria
Altana Pharma/Nycomed
Vienna, , Austria
Altana Pharma/Nycomed
Vienna, , Austria
Altana Pharma/Nycomed
Bouge, , Belgium
Altana Pharma/Nycomed
Brussels, , Belgium
Altana Pharma/Nycomed
Brussels, , Belgium
Altana Pharma/Nycomed
Brussels, , Belgium
Altana Pharma/Nycomed
Brussels, , Belgium
Altana Pharma/Nycomed
Edegem, , Belgium
Altana Pharma/Nycomed
Eupen, , Belgium
Altana Pharma/Nycomed
Ghent, , Belgium
Altana Pharma/Nycomed
Jette, , Belgium
Altana Pharma/Nycomed
Kortrijk, , Belgium
Altana Pharma/Nycomed
Leuven, , Belgium
Altana Pharma/Nycomed
Merksem, , Belgium
Altana Pharma/Nycomed
Ostend, , Belgium
Altana Pharma/Nycomed
Saint Niklaas, , Belgium
Altana Pharma/Nycomed
Sart-Tilman/Liege 1, , Belgium
Altana Pharma/Nycomed
Belo Horizonte - Minas Gerais, , Brazil
Altana Pharma/Nycomed
Botucatu - SP CEP, , Brazil
Altana Pharma/Nycomed
Campinas - Sao Paulo, , Brazil
Altana Pharma/Nycomed
Campinas /SP, , Brazil
Altana Pharma/Nycomed
Curitiba-PR, , Brazil
Altana Pharma/Nycomed
Ilha Do Fundao - Rio de Janeiro - RJ, , Brazil
Altana Pharma/Nycomed
Pinheiros Sao Paulo - SP, , Brazil
Altana Pharma/Nycomed
Porto Alegre, , Brazil
Altana Pharma/Nycomed
Porto Alegre - RS, , Brazil
Altana Pharma/Nycomed
Porto Alegre-RS, , Brazil
Altana Pharma/Nycomed
Ribeirao Preto-SP, , Brazil
Altana Pharma/Nycomed
Abbotsford, BC, , Canada
Altana Pharma/Nycomed
Calgary, , Canada
Altana Pharma/Nycomed
Hamilton, , Canada
Altana Pharma/Nycomed
London, , Canada
Altana Pharma/Nycomed
Montreal, , Canada
Altana Pharma/Nycomed
Montreal, QC, , Canada
Altana Pharma/Nycomed
Québec, , Canada
Altana Pharma/Nycomed
St.-Charles Borromee, QC, , Canada
Altana Pharma/Nycomed
Ste Foy, , Canada
Altana Pharma/Nycomed
Toronto, , Canada
Altana Pharma/Nycomed
Toronto, , Canada
Altana Pharma/Nycomed
Windsor, , Canada
Altana Pharma/Nycomed
Winnipeg, , Canada
Altana Pharma/Nycomed
Agen, , France
Altana Pharma/Nycomed
Bobigny, , France
Altana Pharma/Nycomed
Hagondange, , France
Altana Pharma/Nycomed
Joué-lès-Tours, , France
Altana Pharma/Nycomed
Lamballe, , France
Altana Pharma/Nycomed
Marseille, , France
Altana Pharma/Nycomed
Metz, , France
Altana Pharma/Nycomed
Orthez, , France
Altana Pharma/Nycomed
Saint-Mandé, , France
Altana Pharma/Nycomed
Toul, , France
Altana Pharma/Nycomed
Toulouse, , France
Altana Pharma/Nycomed
Troyes, , France
Altana Pharma/Nycomed
Bonn, , Germany
Altana Pharma/Nycomed
Burg, , Germany
Altana Pharma/Nycomed
Gardelegen, , Germany
Altana Pharma/Nycomed
Heilbronn, , Germany
Altana Pharma/Nycomed
Hennef (Sieg), , Germany
Altana Pharma/Nycomed
Ludwigsburg, , Germany
Altana Pharma/Nycomed
Lübeck, , Germany
Altana Pharma/Nycomed
Magdeburg, , Germany
Altana Pharma/Nycomed
Schwerin, , Germany
Altana Pharma/Nycomed
Hong Kong, , Hong Kong
Altana Pharma/Nycomed
Coimbatore, , India
Altana Pharma/Nycomed
Coimbatore, , India
Altana Pharma/Nycomed
Hyderabad, , India
Altana Pharma/Nycomed
Jaipur, , India
Altana Pharma/Nycomed
Madurai, , India
Altana Pharma/Nycomed
Mumbai, , India
Altana Pharma/Nycomed
Mumbai, , India
Altana Pharma/Nycomed
Mysore, , India
Altana Pharma/Nycomed
Nagpur, , India
Altana Pharma/Nycomed
Pune, , India
Altana Pharma/Nycomed
Pune, , India
Altana Pharma/Nycomed
Aviano (Pordenone), , Italy
Altana Pharma/Nycomed
Bari, , Italy
Altana Pharma/Nycomed
Caserta, , Italy
Altana Pharma/Nycomed
Catania, , Italy
Altana Pharma/Nycomed
Genova, , Italy
Altana Pharma/Nycomed
Mestre (VE), , Italy
Altana Pharma/Nycomed
Milan, , Italy
Altana Pharma/Nycomed
Napoli, , Italy
Altana Pharma/Nycomed
Parma, , Italy
Altana Pharma/Nycomed
Roma, , Italy
Altana Pharma/Nycomed
Roma, , Italy
Altana Pharma/Nycomed
Roma, , Italy
Altana Pharma/Nycomed
Rozzano (Milano), , Italy
Altana Pharma/Nycomed
Kota Kinabalu, Sabah, , Malaysia
Altana Pharma/Nycomed
Kuala Lumpur, , Malaysia
Altana Pharma/Nycomed
Col Del Valle, México D.F., , Mexico
Altana Pharma/Nycomed
Col Del Valle, México D.F., , Mexico
Altana Pharma/Nycomed
Col Héroes de Padierna, México D.F., , Mexico
Altana Pharma/Nycomed
Col. Altavista,Tampico Tamaulipas,Mexico, , Mexico
Altana Pharma/Nycomed
Col. Ex Hacienda Coapa Mexico D.F., , Mexico
Altana Pharma/Nycomed
Héroes de Padierna, México D.F., , Mexico
Altana Pharma/Nycomed
León, Guanajuato Mexico, , Mexico
Altana Pharma/Nycomed
León, Guanajuato, , Mexico
Altana Pharma/Nycomed
Lomas de Chapultepec, México D.F., , Mexico
Altana Pharma/Nycomed
México, D.F., , Mexico
Altana Pharma/Nycomed
Villahermosa, Tabasco, , Mexico
Altana Pharma/Nycomed
Villahermosa, Tabasco, , Mexico
Altana Pharma/Nycomed
Bialystok, , Poland
Altana Pharma/Nycomed
Katowice, , Poland
Altana Pharma/Nycomed
Lodz, , Poland
Altana Pharma/Nycomed
Warsaw, , Poland
Altana Pharma/Nycomed
Warsaw, , Poland
Altana Pharma/Nycomed
Amadora, , Portugal
Altana Pharma/Nycomed
Carnaxide, , Portugal
Altana Pharma/Nycomed
Coimbra, , Portugal
Altana Pharma/Nycomed
Lisbon, , Portugal
Altana Pharma/Nycomed
Lisbon, , Portugal
Altana Pharma/Nycomed
Lisbon, , Portugal
Altana Pharma/Nycomed
Santarém, , Portugal
Altana Pharma/Nycomed
Setúbal, , Portugal
Altana Pharma/Nycomed
Viana do Castelo, , Portugal
Altana Pharma/Nycomed
Vila Nova de Gaia, , Portugal
Altana Pharma/Nycomed
Singapore, , Singapore
Altana Pharma/Nycomed
Berea, Durban, , South Africa
Altana Pharma/Nycomed
Bloemfontein, , South Africa
Altana Pharma/Nycomed
Cape Town, , South Africa
Altana Pharma/Nycomed
eManzimtoti, , South Africa
Altana Pharma/Nycomed
Panorama, , South Africa
Altana Pharma/Nycomed
Port Elizabeth, , South Africa
Altana Pharma/Nycomed
Pretoria, , South Africa
Altana Pharma/Nycomed
Somerset West, , South Africa
Altana Pharma/Nycomed
Seoul, , South Korea
Altana Pharma/Nycomed
Seoul, , South Korea
Altana Pharma/Nycomed
Seoul, , South Korea
Altana Pharma/Nycomed
Seoul, , South Korea
Altana Pharma/Nycomed
Seoul, , South Korea
Altana Pharma/Nycomed
Barcelona, , Spain
Altana Pharma/Nycomed
Barcelona, , Spain
Altana Pharma/Nycomed
Cadiz, , Spain
Altana Pharma/Nycomed
Castellon, , Spain
Altana Pharma/Nycomed
Córdoba, , Spain
Altana Pharma/Nycomed
Granada, , Spain
Altana Pharma/Nycomed
Madrid, , Spain
Altana Pharma/Nycomed
Madrid, , Spain
Altana Pharma/Nycomed
Madrid, , Spain
Altana Pharma/Nycomed
Pamplona, , Spain
Altana Pharma/Nycomed
Ribeira, , Spain
Altana Pharma/Nycomed
Seville, , Spain
Altana Pharma/Nycomed
Basel, , Switzerland
Altana Pharma/Nycomed
Biasca, , Switzerland
Altana Pharma/Nycomed
Biel/Bienne, , Switzerland
Altana Pharma/Nycomed
Lausanne 11 VD, , Switzerland
Altana Pharma/Nycomed
Liestal, , Switzerland
Altana Pharma/Nycomed
Locarno, TI., , Switzerland
Altana Pharma/Nycomed
Lucerne, , Switzerland
Altana Pharma/Nycomed
Payerne, , Switzerland
Altana Pharma/Nycomed
Thun, , Switzerland
Altana Pharma/Nycomed
Zurich, , Switzerland
Altana Pharma/Nycomed
Zurich, , Switzerland
Altana Pharma/Nycomed
Taichung, , Taiwan
Altana Pharma/Nycomed
Tainan City, , Taiwan
Altana Pharma/Nycomed
Taipei, , Taiwan
Altana Pharma/Nycomed
Bath, , United Kingdom
Altana Pharma/Nycomed
Blackpool, , United Kingdom
Altana Pharma/Nycomed
Glasgow, , United Kingdom
Altana Pharma/Nycomed
Middlesex, , United Kingdom
Altana Pharma/Nycomed
Sheffield, , United Kingdom
Altana Pharma/Nycomed
Trowbridge, , United Kingdom
Countries
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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.
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.
Other Identifiers
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BY1023/M3-341
Identifier Type: -
Identifier Source: org_study_id
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