Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
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
1 other identifier
interventional
2,000
21 countries
174
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2006
Shorter than P25 for phase_3
174 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2006
CompletedFirst Posted
Study publicly available on registry
April 11, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedMay 7, 2012
December 1, 2008
10 months
April 10, 2006
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™
8 weeks
Secondary Outcomes (3)
Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™
4 and 8 weeks
Investigator assessment
4 and 8 weeks
Safety and efficacy
4 and 8 weeks
Interventions
Pantoprazole 40 mg o.d.
Eligibility Criteria
You may qualify if:
- Written informed consent
- Outpatients of at least 18 years (21 years in Argentina)
- Patient considered to have GERD symptoms
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (186)
Altana Pharma/Nycomed
Buenos Aires, 1161, Argentina
Altana Pharma/Nycomed
Buenos Aires, 1405, Argentina
Altana Pharma/Nycomed
Buenos Aires, Argentina
Altana Pharma/Nycomed
La Plata, 1900, Argentina
Altana Pharma/Nycomed
Bedford Park SA, 5042, Australia
Altana Pharma/Nycomed
Bondi Junction, NSW 2022, Australia
Altana Pharma/Nycomed
Fitzroy, VIC 3065, Australia
Altana Pharma/Nycomed
Footscray, VIC 3011, Australia
Altana Pharma/Nycomed
Fremantle, WA, 6959, Australia
Altana Pharma/Nycomed
Kippa_ring, QLD 4021, Australia
Altana Pharma/Nycomed
Melbourne, VIC 3050, Australia
Altana Pharma/Nycomed
NSW, 2310, Australia
Altana Pharma/Nycomed
Penrith, NSW, Australia
Altana Pharma/Nycomed
Phrahran, VIC 3181, Australia
Altana Pharma/Nycomed
Deutschlandsberg, 8539, Austria
Altana Pharma/Nycomed
Feldbach, 8330, Austria
Altana Pharma/Nycomed
Graz, 8010, Austria
Altana Pharma/Nycomed
Krems A. D. Donau, 3500, Austria
Altana Pharma/Nycomed
Lilienfeld, 3180, Austria
Altana Pharma/Nycomed
Sankt Pölten, 3100, Austria
Altana Pharma/Nycomed
Vienna, 1100, Austria
Altana Pharma/Nycomed
Vienna, 1130, Austria
Altana Pharma/Nycomed
Vienna, 1140, Austria
Altana Pharma/Nycomed
Vienna, 1160, Austria
Altana Pharma/Nycomed
Vienna, 1170, Austria
Altana Pharma/Nycomed
Vienna, 1220, Austria
Altana Pharma/Nycomed
Bouge, 5004, Belgium
Altana Pharma/Nycomed
Brussels, 1000, Belgium
Altana Pharma/Nycomed
Brussels, 1020, Belgium
Altana Pharma/Nycomed
Brussels, 1040, Belgium
Altana Pharma/Nycomed
Brussels, 1070, Belgium
Altana Pharma/Nycomed
Edegem, 2650, Belgium
Altana Pharma/Nycomed
Eupen, 4700, Belgium
Altana Pharma/Nycomed
Ghent, 9000, Belgium
Altana Pharma/Nycomed
Jette, 1090, Belgium
Altana Pharma/Nycomed
Kortrijk, 8500, Belgium
Altana Pharma/Nycomed
Leuven, 3000, Belgium
Altana Pharma/Nycomed
Merksem, 2170, Belgium
Altana Pharma/Nycomed
Ostend, 8400, Belgium
Altana Pharma/Nycomed
Saint Niklaas, 9100, Belgium
Altana Pharma/Nycomed
Sart-Tilman/Liege 1, 4000, Belgium
Altana Pharma/Nycomed
Belo Horizonte - Minas Gerais, 30130100, Brazil
Altana Pharma/Nycomed
Botucatu - SP CEP, 16618000, Brazil
Altana Pharma/Nycomed
Campinas - Sao Paulo, 13070040, Brazil
Altana Pharma/Nycomed
Campinas /SP, Brazil
Altana Pharma/Nycomed
Curitiba-PR, 80060900, Brazil
Altana Pharma/Nycomed
Ilha Do Fundao - Rio de Janeiro - RJ, 21941590, Brazil
Altana Pharma/Nycomed
Pinheiros Sao Paulo - SP, 1246-000, Brazil
Altana Pharma/Nycomed
Porto Alegre, Brazil
Altana Pharma/Nycomed
Porto Alegre - RS, 90035003, Brazil
Altana Pharma/Nycomed
Porto Alegre-RS, 90020090, Brazil
Altana Pharma/Nycomed
Ribeirao Preto-SP, 14048900, Brazil
Altana Pharma/Nycomed
Abbotsford, BC, V2S 3N5, Canada
Altana Pharma/Nycomed
Calgary, T2N 4N1, Canada
Altana Pharma/Nycomed
Hamilton, L8N 4A6, Canada
Altana Pharma/Nycomed
London, N6A 4G5, Canada
Altana Pharma/Nycomed
Montreal, H3G 1A4, Canada
Altana Pharma/Nycomed
Montreal, QC, H3A 1A1, Canada
Altana Pharma/Nycomed
Québec, H9R 3J1, Canada
Altana Pharma/Nycomed
St.-Charles Borromee, QC, J6E 2C3, Canada
Altana Pharma/Nycomed
Ste Foy, G1S 4L8, Canada
Altana Pharma/Nycomed
Toronto, M3N 2V7, Canada
Altana Pharma/Nycomed
Toronto, M5B 1W8, Canada
Altana Pharma/Nycomed
Windsor, N9A 1C9, Canada
Altana Pharma/Nycomed
Winnipeg, R3A 1R9, Canada
Altana Pharma/Nycomed
Agen, 47000, France
Altana Pharma/Nycomed
Bobigny, 93000, France
Altana Pharma/Nycomed
Hagondange, 57300, France
Altana Pharma/Nycomed
Joué-lès-Tours, 37300, France
Altana Pharma/Nycomed
Lamballe, 22400, France
Altana Pharma/Nycomed
Marseille, 13013, France
Altana Pharma/Nycomed
Metz, 57000, France
Altana Pharma/Nycomed
Orthez, 64300, France
Altana Pharma/Nycomed
Saint-Mandé, 94160, France
Altana Pharma/Nycomed
Toul, 54200, France
Altana Pharma/Nycomed
Toulouse, 31000, France
Altana Pharma/Nycomed
Troyes, 10000, France
Altana Pharma/Nycomed
Bonn, 53173, Germany
Altana Pharma/Nycomed
Burg, 39288, Germany
Altana Pharma/Nycomed
Gardelegen, 39638, Germany
Altana Pharma/Nycomed
Heilbronn, 74081, Germany
Altana Pharma/Nycomed
Hennef (Sieg), 53773, Germany
Altana Pharma/Nycomed
Ludwigsburg, 71640, Germany
Altana Pharma/Nycomed
Lübeck, 23552, Germany
Altana Pharma/Nycomed
Magdeburg, 39130, Germany
Altana Pharma/Nycomed
Schwerin, 19053, Germany
Altana Pharma/Nycomed
Hong Kong, Hong Kong
Altana Pharma/Nycomed
Coimbatore, 641004, India
Altana Pharma/Nycomed
Coimbatore, 641018, India
Altana Pharma/Nycomed
Hyderabad, 500082, India
Altana Pharma/Nycomed
Jaipur, India
Altana Pharma/Nycomed
Madurai, 625002, India
Altana Pharma/Nycomed
Mumbai, 400 008, India
Altana Pharma/Nycomed
Mumbai, 400022, India
Altana Pharma/Nycomed
Mysore, 570020, India
Altana Pharma/Nycomed
Nagpur, 12, India
Altana Pharma/Nycomed
Pune, 411 030, India
Altana Pharma/Nycomed
Pune, 411004, India
Altana Pharma/Nycomed
Aviano (Pordenone), 33081, Italy
Altana Pharma/Nycomed
Bari, 70124, Italy
Altana Pharma/Nycomed
Caserta, 81100, Italy
Altana Pharma/Nycomed
Catania, 95123, Italy
Altana Pharma/Nycomed
Genova, 16132, Italy
Altana Pharma/Nycomed
Mestre (VE), 30174, Italy
Altana Pharma/Nycomed
Milan, 20147, Italy
Altana Pharma/Nycomed
Napoli, 80131, Italy
Altana Pharma/Nycomed
Parma, 43100, Italy
Altana Pharma/Nycomed
Roma, 133, Italy
Altana Pharma/Nycomed
Roma, 135, Italy
Altana Pharma/Nycomed
Roma, 189, Italy
Altana Pharma/Nycomed
Rozzano (Milano), 20089, Italy
Altana Pharma/Nycomed
Kota Kinabalu, Sabah, 88586, Malaysia
Altana Pharma/Nycomed
Kuala Lumpur, 50603, Malaysia
Altana Pharma/Nycomed
Col Del Valle, México D.F., 3100, Mexico
Altana Pharma/Nycomed
Col Del Valle, México D.F., 6760, Mexico
Altana Pharma/Nycomed
Col Héroes de Padierna, México D.F., 10700, Mexico
Altana Pharma/Nycomed
Col. Altavista,Tampico Tamaulipas,Mexico, 89240, Mexico
Altana Pharma/Nycomed
Col. Ex Hacienda Coapa Mexico D.F., 4860, Mexico
Altana Pharma/Nycomed
Héroes de Padierna, México D.F., 3100, Mexico
Altana Pharma/Nycomed
León, Guanajuato Mexico, 36000, Mexico
Altana Pharma/Nycomed
León, Guanajuato, 37320, Mexico
Altana Pharma/Nycomed
Lomas de Chapultepec, México D.F., 11000, Mexico
Altana Pharma/Nycomed
México, D.F., 3100, Mexico
Altana Pharma/Nycomed
Villahermosa, Tabasco, 86000, Mexico
Altana Pharma/Nycomed
Villahermosa, Tabasco, 86085, Mexico
Altana Pharma/Nycomed
Bialystok, 15-276, Poland
Altana Pharma/Nycomed
Katowice, 40-752, Poland
Altana Pharma/Nycomed
Lodz, 90-153, Poland
Altana Pharma/Nycomed
Warsaw, 02-097, Poland
Altana Pharma/Nycomed
Warsaw, 02-507, Poland
Altana Pharma/Nycomed
Amadora, 2720-276, Portugal
Altana Pharma/Nycomed
Carnaxide, 2799-523, Portugal
Altana Pharma/Nycomed
Coimbra, 3001, Portugal
Altana Pharma/Nycomed
Lisbon, 1099-023, Portugal
Altana Pharma/Nycomed
Lisbon, 1349-019, Portugal
Altana Pharma/Nycomed
Lisbon, 1769-053, Portugal
Altana Pharma/Nycomed
Santarém, 2005-177, Portugal
Altana Pharma/Nycomed
Setúbal, 2910-446, Portugal
Altana Pharma/Nycomed
Viana do Castelo, 4900-858, Portugal
Altana Pharma/Nycomed
Vila Nova de Gaia, 4400-346, Portugal
Altana Pharma/Nycomed
Singapore, 1699608, Singapore
Altana Pharma/Nycomed
Berea, Durban, 4000, South Africa
Altana Pharma/Nycomed
Bloemfontein, 9317, South Africa
Altana Pharma/Nycomed
Cape Town, 7530, South Africa
Altana Pharma/Nycomed
eManzimtoti, 4126, South Africa
Altana Pharma/Nycomed
Panorama, 7500, South Africa
Altana Pharma/Nycomed
Port Elizabeth, 6001, South Africa
Altana Pharma/Nycomed
Pretoria, 48, South Africa
Altana Pharma/Nycomed
Somerset West, 7130, South Africa
Altana Pharma/Nycomed
Seoul, 110-744, South Korea
Altana Pharma/Nycomed
Seoul, 135-710, South Korea
Altana Pharma/Nycomed
Seoul, 135-720, South Korea
Altana Pharma/Nycomed
Seoul, 137-040, South Korea
Altana Pharma/Nycomed
Seoul, 138-736, South Korea
Altana Pharma/Nycomed
Barcelona, 8017, Spain
Altana Pharma/Nycomed
Barcelona, 8222, Spain
Altana Pharma/Nycomed
Cadiz, 11009, Spain
Altana Pharma/Nycomed
Castellon, 12004, Spain
Altana Pharma/Nycomed
Córdoba, 14004, Spain
Altana Pharma/Nycomed
Granada, 18014, Spain
Altana Pharma/Nycomed
Madrid, 28035, Spain
Altana Pharma/Nycomed
Madrid, 28046, Spain
Altana Pharma/Nycomed
Madrid, 28200, Spain
Altana Pharma/Nycomed
Pamplona, 31080, Spain
Altana Pharma/Nycomed
Ribeira, 15993, Spain
Altana Pharma/Nycomed
Seville, 41014, Spain
Altana Pharma/Nycomed
Basel, 4031, Switzerland
Altana Pharma/Nycomed
Biasca, 6710, Switzerland
Altana Pharma/Nycomed
Biel/Bienne, 2502, Switzerland
Altana Pharma/Nycomed
Lausanne 11 VD, 1011, Switzerland
Altana Pharma/Nycomed
Liestal, 4410, Switzerland
Altana Pharma/Nycomed
Locarno, TI., 6600, Switzerland
Altana Pharma/Nycomed
Lucerne, 6003, Switzerland
Altana Pharma/Nycomed
Payerne, 1530, Switzerland
Altana Pharma/Nycomed
Thun, 3600, Switzerland
Altana Pharma/Nycomed
Zurich, 8002, Switzerland
Altana Pharma/Nycomed
Zurich, 8050, Switzerland
Altana Pharma/Nycomed
Taichung, 40705, Taiwan
Altana Pharma/Nycomed
Tainan, 701, Taiwan
Altana Pharma/Nycomed
Taipei, Taiwan
Altana Pharma/Nycomed
Bath, BA1 2SR, United Kingdom
Altana Pharma/Nycomed
Blackpool, FY3 7EN, United Kingdom
Altana Pharma/Nycomed
Glasgow, G45 9AW, United Kingdom
Altana Pharma/Nycomed
Middlesex, HA6 2RN, United Kingdom
Altana Pharma/Nycomed
Sheffield, S5 7QB, United Kingdom
Altana Pharma/Nycomed
Trowbridge, BA14 9AR, United Kingdom
Related Publications (2)
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.
PMID: 25200403DERIVEDHeading 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.
PMID: 21569313DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans-Joachim Ulmer, MD
Medical practice, D-71640 Ludwigsburg, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 10, 2006
First Posted
April 11, 2006
Study Start
May 1, 2006
Primary Completion
March 1, 2007
Study Completion
July 1, 2007
Last Updated
May 7, 2012
Record last verified: 2008-12