- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00312806
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
May 4, 2012 updated by: Takeda
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
2000
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, 1161
- Altana Pharma/Nycomed
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Buenos Aires, Argentina, 1405
- Altana Pharma/Nycomed
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Buenos Aires, Argentina
- Altana Pharma/Nycomed
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La Plata, Argentina, 1900
- Altana Pharma/Nycomed
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Bedford Park SA, Australia, 5042
- Altana Pharma/Nycomed
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Bondi Junction, Australia, NSW 2022
- Altana Pharma/Nycomed
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Fitzroy, Australia, VIC 3065
- Altana Pharma/Nycomed
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Footscray, Australia, VIC 3011
- Altana Pharma/Nycomed
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Fremantle, WA, Australia, 6959
- Altana Pharma/Nycomed
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Kippa_ring, Australia, QLD 4021
- Altana Pharma/Nycomed
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Melbourne, Australia, VIC 3050
- Altana Pharma/Nycomed
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NSW, Australia, 2310
- Altana Pharma/Nycomed
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Penrith, NSW, Australia
- Altana Pharma/Nycomed
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Phrahran, Australia, VIC 3181
- Altana Pharma/Nycomed
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Deutschlandsberg, Austria, 8539
- Altana Pharma/Nycomed
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Feldbach, Austria, 8330
- Altana Pharma/Nycomed
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Graz, Austria, 8010
- Altana Pharma/Nycomed
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Krems a. d. Donau, Austria, 3500
- Altana Pharma/Nycomed
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Lilienfeld, Austria, 3180
- Altana Pharma/Nycomed
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St. Pölten, Austria, 3100
- Altana Pharma/Nycomed
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Wien, Austria, 1130
- Altana Pharma/Nycomed
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Wien, Austria, 1140
- Altana Pharma/Nycomed
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Wien, Austria, 1170
- Altana Pharma/Nycomed
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Wien, Austria, 1100
- Altana Pharma/Nycomed
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Wien, Austria, 1160
- Altana Pharma/Nycomed
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Wien, Austria, 1220
- Altana Pharma/Nycomed
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Bouge, Belgium, 5004
- Altana Pharma/Nycomed
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Brussels, Belgium, 1000
- Altana Pharma/Nycomed
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Bruxelles, Belgium, 1020
- Altana Pharma/Nycomed
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Bruxelles, Belgium, 1040
- Altana Pharma/Nycomed
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Bruxelles, Belgium, 1070
- Altana Pharma/Nycomed
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Edegem, Belgium, 2650
- Altana Pharma/Nycomed
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Eupen, Belgium, 4700
- Altana Pharma/Nycomed
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Gent, Belgium, 9000
- Altana Pharma/Nycomed
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Jette, Belgium, 1090
- Altana Pharma/Nycomed
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Kortrijk, Belgium, 8500
- Altana Pharma/Nycomed
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Leuven, Belgium, 3000
- Altana Pharma/Nycomed
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Merksem, Belgium, 2170
- Altana Pharma/Nycomed
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Oostende, Belgium, 8400
- Altana Pharma/Nycomed
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Sart-Tilman/Liege 1, Belgium, 4000
- Altana Pharma/Nycomed
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St. Niklaas, Belgium, 9100
- Altana Pharma/Nycomed
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Belo Horizonte - Minas Gerais, Brazil, 30130100
- Altana Pharma/Nycomed
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Botucatu - SP CEP, Brazil, 16618000
- Altana Pharma/Nycomed
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Campinas - Sao Paulo, Brazil, 13070040
- Altana Pharma/Nycomed
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Campinas /SP, Brazil
- Altana Pharma/Nycomed
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Curitiba-PR, Brazil, 80060900
- Altana Pharma/Nycomed
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Ilha do Fundao - Rio de Janeiro - RJ, Brazil, 21941590
- Altana Pharma/Nycomed
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Pinheiros Sao Paulo - SP, Brazil, 1246-000
- Altana Pharma/Nycomed
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Porto Alegre, Brazil
- Altana Pharma/Nycomed
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Porto Alegre - RS, Brazil, 90035003
- Altana Pharma/Nycomed
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Porto Alegre-RS, Brazil, 90020090
- Altana Pharma/Nycomed
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Ribeirao Preto-SP, Brazil, 14048900
- Altana Pharma/Nycomed
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Abbotsford, BC, Canada, V2S 3N5
- Altana Pharma/Nycomed
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Calgary, Canada, T2N 4N1
- Altana Pharma/Nycomed
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Hamilton, Canada, L8N 4A6
- Altana Pharma/Nycomed
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London, Canada, N6A 4G5
- Altana Pharma/Nycomed
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Montreal, Canada, H3G 1A4
- Altana Pharma/Nycomed
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Montreal, QC, Canada, H3A 1A1
- Altana Pharma/Nycomed
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Quebec, Canada, H9R 3J1
- Altana Pharma/Nycomed
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St.-Charles Borromee, QC, Canada, J6E 2C3
- Altana Pharma/Nycomed
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Ste Foy, Canada, G1S 4L8
- Altana Pharma/Nycomed
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Toronto, Canada, M3N 2V7
- Altana Pharma/Nycomed
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Toronto, Canada, M5B 1W8
- Altana Pharma/Nycomed
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Windsor, Canada, N9A 1C9
- Altana Pharma/Nycomed
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Winnipeg, Canada, R3A 1R9
- Altana Pharma/Nycomed
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Agen, France, 47000
- Altana Pharma/Nycomed
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Bobigny, France, 93000
- Altana Pharma/Nycomed
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Hagondange, France, 57300
- Altana Pharma/Nycomed
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Joue les Tours, France, 37300
- Altana Pharma/Nycomed
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Lamballe, France, 22400
- Altana Pharma/Nycomed
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Marseille, France, 13013
- Altana Pharma/Nycomed
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Metz, France, 57000
- Altana Pharma/Nycomed
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Orthez, France, 64300
- Altana Pharma/Nycomed
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Saint-Mande, France, 94160
- Altana Pharma/Nycomed
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Toul, France, 54200
- Altana Pharma/Nycomed
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Toulouse, France, 31000
- Altana Pharma/Nycomed
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Troyes, France, 10000
- Altana Pharma/Nycomed
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Bonn, Germany, 53173
- Altana Pharma/Nycomed
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Burg, Germany, 39288
- Altana Pharma/Nycomed
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Gardelegen, Germany, 39638
- Altana Pharma/Nycomed
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Heilbronn, Germany, 74081
- Altana Pharma/Nycomed
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Hennef, Germany, 53773
- Altana Pharma/Nycomed
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Ludwigsburg, Germany, 71640
- Altana Pharma/Nycomed
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Lübeck, Germany, 23552
- Altana Pharma/Nycomed
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Magdeburg, Germany, 39130
- Altana Pharma/Nycomed
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Schwerin, Germany, 19053
- Altana Pharma/Nycomed
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Hong Kong, Hong Kong
- Altana Pharma/Nycomed
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Coimbatore, India, 641004
- Altana Pharma/Nycomed
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Coimbatore, India, 641018
- Altana Pharma/Nycomed
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Hyderabad, India, 500082
- Altana Pharma/Nycomed
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Jaipur, India
- Altana Pharma/Nycomed
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Madurai, India, 625002
- Altana Pharma/Nycomed
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Mumbai, India, 400 008
- Altana Pharma/Nycomed
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Mumbai, India, 400022
- Altana Pharma/Nycomed
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Mysore, India, 570020
- Altana Pharma/Nycomed
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Nagpur, India, 12
- Altana Pharma/Nycomed
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Pune, India, 411 030
- Altana Pharma/Nycomed
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Pune, India, 411004
- Altana Pharma/Nycomed
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Aviano (Pordenone), Italy, 33081
- Altana Pharma/Nycomed
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Bari, Italy, 70124
- Altana Pharma/Nycomed
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Caserta, Italy, 81100
- Altana Pharma/Nycomed
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Catania, Italy, 95123
- Altana Pharma/Nycomed
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Genova, Italy, 16132
- Altana Pharma/Nycomed
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Mestre (VE), Italy, 30174
- Altana Pharma/Nycomed
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Milano, Italy, 20147
- Altana Pharma/Nycomed
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Napoli, Italy, 80131
- Altana Pharma/Nycomed
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Parma, Italy, 43100
- Altana Pharma/Nycomed
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Roma, Italy, 133
- Altana Pharma/Nycomed
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Roma, Italy, 135
- Altana Pharma/Nycomed
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Roma, Italy, 189
- Altana Pharma/Nycomed
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Rozzano (Milano), Italy, 20089
- Altana Pharma/Nycomed
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Seoul, Korea, Republic of, 110-744
- Altana Pharma/Nycomed
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Seoul, Korea, Republic of, 135-710
- Altana Pharma/Nycomed
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Seoul, Korea, Republic of, 135-720
- Altana Pharma/Nycomed
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Seoul, Korea, Republic of, 137-040
- Altana Pharma/Nycomed
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Seoul, Korea, Republic of, 138-736
- Altana Pharma/Nycomed
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Kota Kinabalu, Sabah, Malaysia, 88586
- Altana Pharma/Nycomed
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Kuala Lumpur, Malaysia, 50603
- Altana Pharma/Nycomed
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Col Del Valle, México D.F., Mexico, 3100
- Altana Pharma/Nycomed
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Col Del Valle, México D.F., Mexico, 6760
- Altana Pharma/Nycomed
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Col Héroes de Padierna, México D.F., Mexico, 10700
- Altana Pharma/Nycomed
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Col. Altavista,Tampico Tamaulipas,Mexico, Mexico, 89240
- Altana Pharma/Nycomed
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Col. Ex Hacienda Coapa Mexico D.F., Mexico, 4860
- Altana Pharma/Nycomed
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Héroes de Padierna, México D.F., Mexico, 3100
- Altana Pharma/Nycomed
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León, Guanajuato, Mexico, 37320
- Altana Pharma/Nycomed
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León, Guanajuato Mexico, Mexico, 36000
- Altana Pharma/Nycomed
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Lomas de Chapultepec, México D.F., Mexico, 11000
- Altana Pharma/Nycomed
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México, D.F., Mexico, 3100
- Altana Pharma/Nycomed
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Villahermosa, Tabasco, Mexico, 86000
- Altana Pharma/Nycomed
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Villahermosa, Tabasco, Mexico, 86085
- Altana Pharma/Nycomed
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Bialystok, Poland, 15-276
- Altana Pharma/Nycomed
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Katowice, Poland, 40-752
- Altana Pharma/Nycomed
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Lodz, Poland, 90-153
- Altana Pharma/Nycomed
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Warszawa, Poland, 02-097
- Altana Pharma/Nycomed
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Warszawa, Poland, 02-507
- Altana Pharma/Nycomed
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Amadora, Portugal, 2720-276
- Altana Pharma/Nycomed
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Carnaxide, Portugal, 2799-523
- Altana Pharma/Nycomed
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Coimbra, Portugal, 3001
- Altana Pharma/Nycomed
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Lisboa, Portugal, 1099-023
- Altana Pharma/Nycomed
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Lisboa, Portugal, 1349-019
- Altana Pharma/Nycomed
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Lisboa, Portugal, 1769-053
- Altana Pharma/Nycomed
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Santarém, Portugal, 2005-177
- Altana Pharma/Nycomed
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Setúbal, Portugal, 2910-446
- Altana Pharma/Nycomed
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Viana do Castelo, Portugal, 4900-858
- Altana Pharma/Nycomed
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Vila Nova de Gaia, Portugal, 4400-346
- Altana Pharma/Nycomed
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Singapore, Singapore, 1699608
- Altana Pharma/Nycomed
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Amanzimtoti, South Africa, 4126
- Altana Pharma/Nycomed
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Berea, Durban, South Africa, 4000
- Altana Pharma/Nycomed
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Bloemfontein, South Africa, 9317
- Altana Pharma/Nycomed
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Cape Town, South Africa, 7530
- Altana Pharma/Nycomed
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Panorama, South Africa, 7500
- Altana Pharma/Nycomed
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Port Elizabeth, South Africa, 6001
- Altana Pharma/Nycomed
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Pretoria, South Africa, 48
- Altana Pharma/Nycomed
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Somerset-West, South Africa, 7130
- Altana Pharma/Nycomed
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Barcelona, Spain, 8017
- Altana Pharma/Nycomed
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Barcelona, Spain, 8222
- Altana Pharma/Nycomed
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Castellón de la Plana, Spain, 12004
- Altana Pharma/Nycomed
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Cordoba, Spain, 14004
- Altana Pharma/Nycomed
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Cádiz, Spain, 11009
- Altana Pharma/Nycomed
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Granada, Spain, 18014
- Altana Pharma/Nycomed
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Madrid, Spain, 28046
- Altana Pharma/Nycomed
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Madrid, Spain, 28035
- Altana Pharma/Nycomed
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Madrid, Spain, 28200
- Altana Pharma/Nycomed
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Pamplona, Spain, 31080
- Altana Pharma/Nycomed
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Ribeira, Spain, 15993
- Altana Pharma/Nycomed
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Sevilla, Spain, 41014
- Altana Pharma/Nycomed
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Basel, Switzerland, 4031
- Altana Pharma/Nycomed
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Biasca, Switzerland, 6710
- Altana Pharma/Nycomed
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Biel/Bienne, Switzerland, 2502
- Altana Pharma/Nycomed
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Lausanne 11 VD, Switzerland, 1011
- Altana Pharma/Nycomed
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Liestal, Switzerland, 4410
- Altana Pharma/Nycomed
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Locarno, TI., Switzerland, 6600
- Altana Pharma/Nycomed
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Luzern, Switzerland, 6003
- Altana Pharma/Nycomed
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Payerne, Switzerland, 1530
- Altana Pharma/Nycomed
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Thun, Switzerland, 3600
- Altana Pharma/Nycomed
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Zürich, Switzerland, 8002
- Altana Pharma/Nycomed
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Zürich, Switzerland, 8050
- Altana Pharma/Nycomed
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Taichung, Taiwan, 40705
- Altana Pharma/Nycomed
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Tainan, Taiwan, 701
- Altana Pharma/Nycomed
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Taipei, Taiwan
- Altana Pharma/Nycomed
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Bath, United Kingdom, BA1 2SR
- Altana Pharma/Nycomed
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Blackpool, United Kingdom, FY3 7EN
- Altana Pharma/Nycomed
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Glasgow, United Kingdom, G45 9AW
- Altana Pharma/Nycomed
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Middlesex, United Kingdom, HA6 2RN
- Altana Pharma/Nycomed
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Sheffield, United Kingdom, S5 7QB
- Altana Pharma/Nycomed
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Trowbridge, United Kingdom, BA14 9AR
- Altana Pharma/Nycomed
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Main Inclusion Criteria:
- Written informed consent
- Outpatients of at least 18 years (21 years in Argentina)
- Patient considered to have GERD symptoms
Main 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™
Time Frame: 8 weeks
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™
Time Frame: 4 and 8 weeks
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4 and 8 weeks
|
Investigator assessment
Time Frame: 4 and 8 weeks
|
4 and 8 weeks
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Safety and efficacy
Time Frame: 4 and 8 weeks
|
4 and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hans-Joachim Ulmer, MD, Medical practice, D-71640 Ludwigsburg, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
April 10, 2006
First Submitted That Met QC Criteria
April 10, 2006
First Posted (Estimate)
April 11, 2006
Study Record Updates
Last Update Posted (Estimate)
May 7, 2012
Last Update Submitted That Met QC Criteria
May 4, 2012
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophagitis
- Peptic Ulcer
- Duodenal Diseases
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Pantoprazole
Other Study ID Numbers
- BY1023/M3-341
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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