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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00312806
First received: April 10, 2006
Last updated: May 4, 2012
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
Drug: Pantoprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™ [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™ [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • Investigator assessment [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • Safety and efficacy [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2000
Study Start Date: May 2006
Study Completion Date: July 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pantoprazole
    Pantoprazole 40 mg o.d.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312806

  Hide Study Locations
Locations
Argentina
Altana Pharma/Nycomed
Buenos Aires, Argentina
Altana Pharma/Nycomed
Buenos Aires, Argentina, 1161
Altana Pharma/Nycomed
Buenos Aires, Argentina, 1405
Altana Pharma/Nycomed
La Plata, Argentina, 1900
Australia
Altana Pharma/Nycomed
Bedford Park SA, Australia, 5042
Altana Pharma/Nycomed
Bondi Junction, Australia, NSW 2022
Altana Pharma/Nycomed
Fitzroy, Australia, VIC 3065
Altana Pharma/Nycomed
Footscray, Australia, VIC 3011
Altana Pharma/Nycomed
Fremantle, WA, Australia, 6959
Altana Pharma/Nycomed
Kippa_ring, Australia, QLD 4021
Altana Pharma/Nycomed
Melbourne, Australia, VIC 3050
Altana Pharma/Nycomed
NSW, Australia, 2310
Altana Pharma/Nycomed
Penrith, NSW, Australia
Altana Pharma/Nycomed
Phrahran, Australia, VIC 3181
Austria
Altana Pharma/Nycomed
Deutschlandsberg, Austria, 8539
Altana Pharma/Nycomed
Feldbach, Austria, 8330
Altana Pharma/Nycomed
Graz, Austria, 8010
Altana Pharma/Nycomed
Krems a. d. Donau, Austria, 3500
Altana Pharma/Nycomed
Lilienfeld, Austria, 3180
Altana Pharma/Nycomed
St. Pölten, Austria, 3100
Altana Pharma/Nycomed
Wien, Austria, 1100
Altana Pharma/Nycomed
Wien, Austria, 1220
Altana Pharma/Nycomed
Wien, Austria, 1170
Altana Pharma/Nycomed
Wien, Austria, 1160
Altana Pharma/Nycomed
Wien, Austria, 1130
Altana Pharma/Nycomed
Wien, Austria, 1140
Belgium
Altana Pharma/Nycomed
Bouge, Belgium, 5004
Altana Pharma/Nycomed
Brussels, Belgium, 1000
Altana Pharma/Nycomed
Bruxelles, Belgium, 1020
Altana Pharma/Nycomed
Bruxelles, Belgium, 1070
Altana Pharma/Nycomed
Bruxelles, Belgium, 1040
Altana Pharma/Nycomed
Edegem, Belgium, 2650
Altana Pharma/Nycomed
Eupen, Belgium, 4700
Altana Pharma/Nycomed
Gent, Belgium, 9000
Altana Pharma/Nycomed
Jette, Belgium, 1090
Altana Pharma/Nycomed
Kortrijk, Belgium, 8500
Altana Pharma/Nycomed
Leuven, Belgium, 3000
Altana Pharma/Nycomed
Merksem, Belgium, 2170
Altana Pharma/Nycomed
Oostende, Belgium, 8400
Altana Pharma/Nycomed
Sart-Tilman/Liege 1, Belgium, 4000
Altana Pharma/Nycomed
St. Niklaas, Belgium, 9100
Brazil
Altana Pharma/Nycomed
Belo Horizonte - Minas Gerais, Brazil, 30130100
Altana Pharma/Nycomed
Botucatu - SP CEP, Brazil, 16618000
Altana Pharma/Nycomed
Campinas - Sao Paulo, Brazil, 13070040
Altana Pharma/Nycomed
Campinas /SP, Brazil
Altana Pharma/Nycomed
Curitiba-PR, Brazil, 80060900
Altana Pharma/Nycomed
Ilha do Fundao - Rio de Janeiro - RJ, Brazil, 21941590
Altana Pharma/Nycomed
Pinheiros Sao Paulo - SP, Brazil, 1246-000
Altana Pharma/Nycomed
Porto Alegre, Brazil
Altana Pharma/Nycomed
Porto Alegre - RS, Brazil, 90035003
Altana Pharma/Nycomed
Porto Alegre-RS, Brazil, 90020090
Altana Pharma/Nycomed
Ribeirao Preto-SP, Brazil, 14048900
Canada
Altana Pharma/Nycomed
Abbotsford, BC, Canada, V2S 3N5
Altana Pharma/Nycomed
Calgary, Canada, T2N 4N1
Altana Pharma/Nycomed
Hamilton, Canada, L8N 4A6
Altana Pharma/Nycomed
London, Canada, N6A 4G5
Altana Pharma/Nycomed
Montreal, Canada, H3G 1A4
Altana Pharma/Nycomed
Montreal, QC, Canada, H3A 1A1
Altana Pharma/Nycomed
Quebec, Canada, H9R 3J1
Altana Pharma/Nycomed
St.-Charles Borromee, QC, Canada, J6E 2C3
Altana Pharma/Nycomed
Ste Foy, Canada, G1S 4L8
Altana Pharma/Nycomed
Toronto, Canada, M3N 2V7
Altana Pharma/Nycomed
Toronto, Canada, M5B 1W8
Altana Pharma/Nycomed
Windsor, Canada, N9A 1C9
Altana Pharma/Nycomed
Winnipeg, Canada, R3A 1R9
France
Altana Pharma/Nycomed
Agen, France, 47000
Altana Pharma/Nycomed
Bobigny, France, 93000
Altana Pharma/Nycomed
Hagondange, France, 57300
Altana Pharma/Nycomed
Joue les Tours, France, 37300
Altana Pharma/Nycomed
Lamballe, France, 22400
Altana Pharma/Nycomed
Marseille, France, 13013
Altana Pharma/Nycomed
Metz, France, 57000
Altana Pharma/Nycomed
Orthez, France, 64300
Altana Pharma/Nycomed
Saint-Mande, France, 94160
Altana Pharma/Nycomed
Toul, France, 54200
Altana Pharma/Nycomed
Toulouse, France, 31000
Altana Pharma/Nycomed
Troyes, France, 10000
Germany
Altana Pharma/Nycomed
Bonn, Germany, 53173
Altana Pharma/Nycomed
Burg, Germany, 39288
Altana Pharma/Nycomed
Gardelegen, Germany, 39638
Altana Pharma/Nycomed
Heilbronn, Germany, 74081
Altana Pharma/Nycomed
Hennef, Germany, 53773
Altana Pharma/Nycomed
Ludwigsburg, Germany, 71640
Altana Pharma/Nycomed
Lübeck, Germany, 23552
Altana Pharma/Nycomed
Magdeburg, Germany, 39130
Altana Pharma/Nycomed
Schwerin, Germany, 19053
Hong Kong
Altana Pharma/Nycomed
Hong Kong, Hong Kong
India
Altana Pharma/Nycomed
Coimbatore, India, 641018
Altana Pharma/Nycomed
Coimbatore, India, 641004
Altana Pharma/Nycomed
Hyderabad, India, 500082
Altana Pharma/Nycomed
Jaipur, India
Altana Pharma/Nycomed
Madurai, India, 625002
Altana Pharma/Nycomed
Mumbai, India, 400022
Altana Pharma/Nycomed
Mumbai, India, 400 008
Altana Pharma/Nycomed
Mysore, India, 570020
Altana Pharma/Nycomed
Nagpur, India, 12
Altana Pharma/Nycomed
Pune, India, 411004
Altana Pharma/Nycomed
Pune, India, 411 030
Italy
Altana Pharma/Nycomed
Aviano (Pordenone), Italy, 33081
Altana Pharma/Nycomed
Bari, Italy, 70124
Altana Pharma/Nycomed
Caserta, Italy, 81100
Altana Pharma/Nycomed
Catania, Italy, 95123
Altana Pharma/Nycomed
Genova, Italy, 16132
Altana Pharma/Nycomed
Mestre (VE), Italy, 30174
Altana Pharma/Nycomed
Milano, Italy, 20147
Altana Pharma/Nycomed
Napoli, Italy, 80131
Altana Pharma/Nycomed
Parma, Italy, 43100
Altana Pharma/Nycomed
Roma, Italy, 133
Altana Pharma/Nycomed
Roma, Italy, 135
Altana Pharma/Nycomed
Roma, Italy, 189
Altana Pharma/Nycomed
Rozzano (Milano), Italy, 20089
Korea, Republic of
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 138-736
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 135-710
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 135-720
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 137-040
Altana Pharma/Nycomed
Seoul, Korea, Republic of, 110-744
Malaysia
Altana Pharma/Nycomed
Kota Kinabalu, Sabah, Malaysia, 88586
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia, 50603
Mexico
Altana Pharma/Nycomed
Col Del Valle, México D.F., Mexico, 6760
Altana Pharma/Nycomed
Col Del Valle, México D.F., Mexico, 3100
Altana Pharma/Nycomed
Col Héroes de Padierna, México D.F., Mexico, 10700
Altana Pharma/Nycomed
Col. Altavista,Tampico Tamaulipas,Mexico, Mexico, 89240
Altana Pharma/Nycomed
Col. Ex Hacienda Coapa Mexico D.F., Mexico, 4860
Altana Pharma/Nycomed
Héroes de Padierna, México D.F., Mexico, 3100
Altana Pharma/Nycomed
León, Guanajuato, Mexico, 37320
Altana Pharma/Nycomed
León, Guanajuato Mexico, Mexico, 36000
Altana Pharma/Nycomed
Lomas de Chapultepec, México D.F., Mexico, 11000
Altana Pharma/Nycomed
México, D.F., Mexico, 3100
Altana Pharma/Nycomed
Villahermosa, Tabasco, Mexico, 86085
Altana Pharma/Nycomed
Villahermosa, Tabasco, Mexico, 86000
Poland
Altana Pharma/Nycomed
Bialystok, Poland, 15-276
Altana Pharma/Nycomed
Katowice, Poland, 40-752
Altana Pharma/Nycomed
Lodz, Poland, 90-153
Altana Pharma/Nycomed
Warszawa, Poland, 02-507
Altana Pharma/Nycomed
Warszawa, Poland, 02-097
Portugal
Altana Pharma/Nycomed
Amadora, Portugal, 2720-276
Altana Pharma/Nycomed
Carnaxide, Portugal, 2799-523
Altana Pharma/Nycomed
Coimbra, Portugal, 3001
Altana Pharma/Nycomed
Lisboa, Portugal, 1349-019
Altana Pharma/Nycomed
Lisboa, Portugal, 1769-053
Altana Pharma/Nycomed
Lisboa, Portugal, 1099-023
Altana Pharma/Nycomed
Santarém, Portugal, 2005-177
Altana Pharma/Nycomed
Setúbal, Portugal, 2910-446
Altana Pharma/Nycomed
Viana do Castelo, Portugal, 4900-858
Altana Pharma/Nycomed
Vila Nova de Gaia, Portugal, 4400-346
Singapore
Altana Pharma/Nycomed
Singapore, Singapore, 1699608
South Africa
Altana Pharma/Nycomed
Amanzimtoti, South Africa, 4126
Altana Pharma/Nycomed
Berea, Durban, South Africa, 4000
Altana Pharma/Nycomed
Bloemfontein, South Africa, 9317
Altana Pharma/Nycomed
Cape Town, South Africa, 7530
Altana Pharma/Nycomed
Panorama, South Africa, 7500
Altana Pharma/Nycomed
Port Elizabeth, South Africa, 6001
Altana Pharma/Nycomed
Pretoria, South Africa, 48
Altana Pharma/Nycomed
Somerset-West, South Africa, 7130
Spain
Altana Pharma/Nycomed
Barcelona, Spain, 8017
Altana Pharma/Nycomed
Barcelona, Spain, 8222
Altana Pharma/Nycomed
Castellón de la Plana, Spain, 12004
Altana Pharma/Nycomed
Cordoba, Spain, 14004
Altana Pharma/Nycomed
Cádiz, Spain, 11009
Altana Pharma/Nycomed
Granada, Spain, 18014
Altana Pharma/Nycomed
Madrid, Spain, 28200
Altana Pharma/Nycomed
Madrid, Spain, 28035
Altana Pharma/Nycomed
Madrid, Spain, 28046
Altana Pharma/Nycomed
Pamplona, Spain, 31080
Altana Pharma/Nycomed
Ribeira, Spain, 15993
Altana Pharma/Nycomed
Sevilla, Spain, 41014
Switzerland
Altana Pharma/Nycomed
Basel, Switzerland, 4031
Altana Pharma/Nycomed
Biasca, Switzerland, 6710
Altana Pharma/Nycomed
Biel/Bienne, Switzerland, 2502
Altana Pharma/Nycomed
Lausanne 11 VD, Switzerland, 1011
Altana Pharma/Nycomed
Liestal, Switzerland, 4410
Altana Pharma/Nycomed
Locarno, TI., Switzerland, 6600
Altana Pharma/Nycomed
Luzern, Switzerland, 6003
Altana Pharma/Nycomed
Payerne, Switzerland, 1530
Altana Pharma/Nycomed
Thun, Switzerland, 3600
Altana Pharma/Nycomed
Zürich, Switzerland, 8050
Altana Pharma/Nycomed
Zürich, Switzerland, 8002
Taiwan
Altana Pharma/Nycomed
Taichung, Taiwan, 40705
Altana Pharma/Nycomed
Tainan, Taiwan, 701
Altana Pharma/Nycomed
Taipei, Taiwan
United Kingdom
Altana Pharma/Nycomed
Bath, United Kingdom, BA1 2SR
Altana Pharma/Nycomed
Blackpool, United Kingdom, FY3 7EN
Altana Pharma/Nycomed
Glasgow, United Kingdom, G45 9AW
Altana Pharma/Nycomed
Middlesex, United Kingdom, HA6 2RN
Altana Pharma/Nycomed
Sheffield, United Kingdom, S5 7QB
Altana Pharma/Nycomed
Trowbridge, United Kingdom, BA14 9AR
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: Hans-Joachim Ulmer, MD Medical practice, D-71640 Ludwigsburg, Germany
  More Information

No publications provided by Takeda

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00312806     History of Changes
Other Study ID Numbers: BY1023/M3-341
Study First Received: April 10, 2006
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Takeda:
Gastroesophageal Reflux Disease
GERD
Pantoprazole
ReQuestTM

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Pantoprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014