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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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Buenos Aires
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Argentina
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La Plata
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Austria
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Deutschlandsberg
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Austria
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Feldbach
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Austria
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Graz
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Austria
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Krems a. d. Donau
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Austria
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Lilienfeld
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Austria
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St. Pölten
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Austria
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Wien
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Belgium
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Bouge
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Edegem
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Belgium
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Eupen
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Belgium
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Gent
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Belgium
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Jette
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Merksem
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Belgium
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Oostende
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Belgium
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Sart-Tilman/Liege 1
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Belgium
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St. Niklaas
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Brazil
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Belo Horizonte - Minas Gerais
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Botucatu - SP CEP
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Campinas - Sao Paulo
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Campinas /SP
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Curitiba-PR
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Ilha do Fundao - Rio de Janeiro - RJ
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Pinheiros Sao Paulo - SP
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Porto Alegre - RS
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Porto Alegre-RS
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Porto Alegre
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Ribeirao Preto-SP
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Abbotsford, BC
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Calgary
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Hamilton
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Hennef
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Lübeck
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Germany
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Schwerin
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Biasca
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Liestal
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Switzerland
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Payerne
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Zürich
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Taichung
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Blackpool
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Sheffield
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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/study/NCT00312806
Trial related presentations / 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.
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/study/NCT00312806