Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00312806




Registration number
NCT00312806
Ethics application status
Date submitted
10/04/2006
Date registered
11/04/2006
Date last updated
7/05/2012

Titles & IDs
Public title
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
Scientific 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
Secondary ID [1] 0 0
BY1023/M3-341
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux Disease (GERD) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pantoprazole

Treatment: Drugs: Pantoprazole
Pantoprazole 40 mg o.d.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™
Timepoint [1] 0 0
4 and 8 weeks
Secondary outcome [2] 0 0
Investigator assessment
Timepoint [2] 0 0
4 and 8 weeks
Secondary outcome [3] 0 0
Safety and efficacy
Timepoint [3] 0 0
4 and 8 weeks

Eligibility
Key inclusion criteria
Main

- Written informed consent

- Outpatients of at least 18 years (21 years in Argentina)

- Patient considered to have GERD symptoms

Main
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2007
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Altana Pharma/Nycomed - Bedford Park SA
Recruitment hospital [2] 0 0
Altana Pharma/Nycomed - Bondi Junction
Recruitment hospital [3] 0 0
Altana Pharma/Nycomed - Fitzroy
Recruitment hospital [4] 0 0
Altana Pharma/Nycomed - Footscray
Recruitment hospital [5] 0 0
Altana Pharma/Nycomed - Fremantle, WA
Recruitment hospital [6] 0 0
Altana Pharma/Nycomed - Kippa_ring
Recruitment hospital [7] 0 0
Altana Pharma/Nycomed - Melbourne
Recruitment hospital [8] 0 0
Altana Pharma/Nycomed - NSW
Recruitment hospital [9] 0 0
Altana Pharma/Nycomed - Penrith, NSW
Recruitment hospital [10] 0 0
Altana Pharma/Nycomed - Phrahran
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park SA
Recruitment postcode(s) [2] 0 0
NSW 2022 - Bondi Junction
Recruitment postcode(s) [3] 0 0
VIC 3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
VIC 3011 - Footscray
Recruitment postcode(s) [5] 0 0
6959 - Fremantle, WA
Recruitment postcode(s) [6] 0 0
QLD 4021 - Kippa_ring
Recruitment postcode(s) [7] 0 0
VIC 3050 - Melbourne
Recruitment postcode(s) [8] 0 0
2310 - NSW
Recruitment postcode(s) [9] 0 0
- Penrith, NSW
Recruitment postcode(s) [10] 0 0
VIC 3181 - Phrahran
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
La Plata
Country [3] 0 0
Austria
State/province [3] 0 0
Deutschlandsberg
Country [4] 0 0
Austria
State/province [4] 0 0
Feldbach
Country [5] 0 0
Austria
State/province [5] 0 0
Graz
Country [6] 0 0
Austria
State/province [6] 0 0
Krems a. d. Donau
Country [7] 0 0
Austria
State/province [7] 0 0
Lilienfeld
Country [8] 0 0
Austria
State/province [8] 0 0
St. Pölten
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Belgium
State/province [10] 0 0
Bouge
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Edegem
Country [14] 0 0
Belgium
State/province [14] 0 0
Eupen
Country [15] 0 0
Belgium
State/province [15] 0 0
Gent
Country [16] 0 0
Belgium
State/province [16] 0 0
Jette
Country [17] 0 0
Belgium
State/province [17] 0 0
Kortrijk
Country [18] 0 0
Belgium
State/province [18] 0 0
Leuven
Country [19] 0 0
Belgium
State/province [19] 0 0
Merksem
Country [20] 0 0
Belgium
State/province [20] 0 0
Oostende
Country [21] 0 0
Belgium
State/province [21] 0 0
Sart-Tilman/Liege 1
Country [22] 0 0
Belgium
State/province [22] 0 0
St. Niklaas
Country [23] 0 0
Brazil
State/province [23] 0 0
Belo Horizonte - Minas Gerais
Country [24] 0 0
Brazil
State/province [24] 0 0
Botucatu - SP CEP
Country [25] 0 0
Brazil
State/province [25] 0 0
Campinas - Sao Paulo
Country [26] 0 0
Brazil
State/province [26] 0 0
Campinas /SP
Country [27] 0 0
Brazil
State/province [27] 0 0
Curitiba-PR
Country [28] 0 0
Brazil
State/province [28] 0 0
Ilha do Fundao - Rio de Janeiro - RJ
Country [29] 0 0
Brazil
State/province [29] 0 0
Pinheiros Sao Paulo - SP
Country [30] 0 0
Brazil
State/province [30] 0 0
Porto Alegre - RS
Country [31] 0 0
Brazil
State/province [31] 0 0
Porto Alegre-RS
Country [32] 0 0
Brazil
State/province [32] 0 0
Porto Alegre
Country [33] 0 0
Brazil
State/province [33] 0 0
Ribeirao Preto-SP
Country [34] 0 0
Canada
State/province [34] 0 0
Abbotsford, BC
Country [35] 0 0
Canada
State/province [35] 0 0
Calgary
Country [36] 0 0
Canada
State/province [36] 0 0
Hamilton
Country [37] 0 0
Canada
State/province [37] 0 0
London
Country [38] 0 0
Canada
State/province [38] 0 0
Montreal, QC
Country [39] 0 0
Canada
State/province [39] 0 0
Montreal
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
Country [41] 0 0
Canada
State/province [41] 0 0
St.-Charles Borromee, QC
Country [42] 0 0
Canada
State/province [42] 0 0
Ste Foy
Country [43] 0 0
Canada
State/province [43] 0 0
Toronto
Country [44] 0 0
Canada
State/province [44] 0 0
Windsor
Country [45] 0 0
Canada
State/province [45] 0 0
Winnipeg
Country [46] 0 0
France
State/province [46] 0 0
Agen
Country [47] 0 0
France
State/province [47] 0 0
Bobigny
Country [48] 0 0
France
State/province [48] 0 0
Hagondange
Country [49] 0 0
France
State/province [49] 0 0
Joue les Tours
Country [50] 0 0
France
State/province [50] 0 0
Lamballe
Country [51] 0 0
France
State/province [51] 0 0
Marseille
Country [52] 0 0
France
State/province [52] 0 0
Metz
Country [53] 0 0
France
State/province [53] 0 0
Orthez
Country [54] 0 0
France
State/province [54] 0 0
Saint-Mande
Country [55] 0 0
France
State/province [55] 0 0
Toulouse
Country [56] 0 0
France
State/province [56] 0 0
Toul
Country [57] 0 0
France
State/province [57] 0 0
Troyes
Country [58] 0 0
Germany
State/province [58] 0 0
Bonn
Country [59] 0 0
Germany
State/province [59] 0 0
Burg
Country [60] 0 0
Germany
State/province [60] 0 0
Gardelegen
Country [61] 0 0
Germany
State/province [61] 0 0
Heilbronn
Country [62] 0 0
Germany
State/province [62] 0 0
Hennef
Country [63] 0 0
Germany
State/province [63] 0 0
Ludwigsburg
Country [64] 0 0
Germany
State/province [64] 0 0
Lübeck
Country [65] 0 0
Germany
State/province [65] 0 0
Magdeburg
Country [66] 0 0
Germany
State/province [66] 0 0
Schwerin
Country [67] 0 0
Hong Kong
State/province [67] 0 0
Hong Kong
Country [68] 0 0
India
State/province [68] 0 0
Coimbatore
Country [69] 0 0
India
State/province [69] 0 0
Hyderabad
Country [70] 0 0
India
State/province [70] 0 0
Jaipur
Country [71] 0 0
India
State/province [71] 0 0
Madurai
Country [72] 0 0
India
State/province [72] 0 0
Mumbai
Country [73] 0 0
India
State/province [73] 0 0
Mysore
Country [74] 0 0
India
State/province [74] 0 0
Nagpur
Country [75] 0 0
India
State/province [75] 0 0
Pune
Country [76] 0 0
Italy
State/province [76] 0 0
Aviano (Pordenone)
Country [77] 0 0
Italy
State/province [77] 0 0
Bari
Country [78] 0 0
Italy
State/province [78] 0 0
Caserta
Country [79] 0 0
Italy
State/province [79] 0 0
Catania
Country [80] 0 0
Italy
State/province [80] 0 0
Genova
Country [81] 0 0
Italy
State/province [81] 0 0
Mestre (VE)
Country [82] 0 0
Italy
State/province [82] 0 0
Milano
Country [83] 0 0
Italy
State/province [83] 0 0
Napoli
Country [84] 0 0
Italy
State/province [84] 0 0
Parma
Country [85] 0 0
Italy
State/province [85] 0 0
Roma
Country [86] 0 0
Italy
State/province [86] 0 0
Rozzano (Milano)
Country [87] 0 0
Korea, Republic of
State/province [87] 0 0
Seoul
Country [88] 0 0
Malaysia
State/province [88] 0 0
Kota Kinabalu, Sabah
Country [89] 0 0
Malaysia
State/province [89] 0 0
Kuala Lumpur
Country [90] 0 0
Mexico
State/province [90] 0 0
Col Del Valle, México D.F.
Country [91] 0 0
Mexico
State/province [91] 0 0
Col Héroes de Padierna, México D.F.
Country [92] 0 0
Mexico
State/province [92] 0 0
Col. Altavista,Tampico Tamaulipas,Mexico
Country [93] 0 0
Mexico
State/province [93] 0 0
Col. Ex Hacienda Coapa Mexico D.F.
Country [94] 0 0
Mexico
State/province [94] 0 0
Héroes de Padierna, México D.F.
Country [95] 0 0
Mexico
State/province [95] 0 0
León, Guanajuato Mexico
Country [96] 0 0
Mexico
State/province [96] 0 0
León, Guanajuato
Country [97] 0 0
Mexico
State/province [97] 0 0
Lomas de Chapultepec, México D.F.
Country [98] 0 0
Mexico
State/province [98] 0 0
México, D.F.
Country [99] 0 0
Mexico
State/province [99] 0 0
Villahermosa, Tabasco
Country [100] 0 0
Poland
State/province [100] 0 0
Bialystok
Country [101] 0 0
Poland
State/province [101] 0 0
Katowice
Country [102] 0 0
Poland
State/province [102] 0 0
Lodz
Country [103] 0 0
Poland
State/province [103] 0 0
Warszawa
Country [104] 0 0
Portugal
State/province [104] 0 0
Amadora
Country [105] 0 0
Portugal
State/province [105] 0 0
Carnaxide
Country [106] 0 0
Portugal
State/province [106] 0 0
Coimbra
Country [107] 0 0
Portugal
State/province [107] 0 0
Lisboa
Country [108] 0 0
Portugal
State/province [108] 0 0
Santarém
Country [109] 0 0
Portugal
State/province [109] 0 0
Setúbal
Country [110] 0 0
Portugal
State/province [110] 0 0
Viana do Castelo
Country [111] 0 0
Portugal
State/province [111] 0 0
Vila Nova de Gaia
Country [112] 0 0
Singapore
State/province [112] 0 0
Singapore
Country [113] 0 0
South Africa
State/province [113] 0 0
Amanzimtoti
Country [114] 0 0
South Africa
State/province [114] 0 0
Berea, Durban
Country [115] 0 0
South Africa
State/province [115] 0 0
Bloemfontein
Country [116] 0 0
South Africa
State/province [116] 0 0
Cape Town
Country [117] 0 0
South Africa
State/province [117] 0 0
Panorama
Country [118] 0 0
South Africa
State/province [118] 0 0
Port Elizabeth
Country [119] 0 0
South Africa
State/province [119] 0 0
Pretoria
Country [120] 0 0
South Africa
State/province [120] 0 0
Somerset-West
Country [121] 0 0
Spain
State/province [121] 0 0
Barcelona
Country [122] 0 0
Spain
State/province [122] 0 0
Castellón de la Plana
Country [123] 0 0
Spain
State/province [123] 0 0
Cordoba
Country [124] 0 0
Spain
State/province [124] 0 0
Cádiz
Country [125] 0 0
Spain
State/province [125] 0 0
Granada
Country [126] 0 0
Spain
State/province [126] 0 0
Madrid
Country [127] 0 0
Spain
State/province [127] 0 0
Pamplona
Country [128] 0 0
Spain
State/province [128] 0 0
Ribeira
Country [129] 0 0
Spain
State/province [129] 0 0
Sevilla
Country [130] 0 0
Switzerland
State/province [130] 0 0
Basel
Country [131] 0 0
Switzerland
State/province [131] 0 0
Biasca
Country [132] 0 0
Switzerland
State/province [132] 0 0
Biel/Bienne
Country [133] 0 0
Switzerland
State/province [133] 0 0
Lausanne 11 VD
Country [134] 0 0
Switzerland
State/province [134] 0 0
Liestal
Country [135] 0 0
Switzerland
State/province [135] 0 0
Locarno, TI.
Country [136] 0 0
Switzerland
State/province [136] 0 0
Luzern
Country [137] 0 0
Switzerland
State/province [137] 0 0
Payerne
Country [138] 0 0
Switzerland
State/province [138] 0 0
Thun
Country [139] 0 0
Switzerland
State/province [139] 0 0
Zürich
Country [140] 0 0
Taiwan
State/province [140] 0 0
Taichung
Country [141] 0 0
Taiwan
State/province [141] 0 0
Tainan
Country [142] 0 0
Taiwan
State/province [142] 0 0
Taipei
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Bath
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Blackpool
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Glasgow
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Middlesex
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Sheffield
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Trowbridge

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00312806
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hans-Joachim Ulmer, MD
Address 0 0
Medical practice, D-71640 Ludwigsburg, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00312806