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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00336219




Registration number
NCT00336219
Ethics application status
Date submitted
12/06/2006
Date registered
13/06/2006
Date last updated
7/05/2012

Titles & IDs
Public title
Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)
Scientific title
COMPETITION: Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease (GERD) Symptom Changes
Secondary ID [1] 0 0
BY1023/M3-343
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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

Active comparator: 1 - Pantoprazole 40 mg


Treatment: Drugs: Pantoprazole
Symptom Assessment after treatment with Pantoprozole 40 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
symptom assessment as measured by ReQuest™ questionnaire and investigator.
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
endoscopic healing after 28 days
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
health-related quality of life after 28 days
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
safety.
Timepoint [4] 0 0
28 days

Eligibility
Key inclusion criteria
Main

* Written informed consent
* Outpatients
* History of GERD-related symptoms for at least 6 months prior to study inclusion
* Endoscopically confirmed erosive GERD or non-erosive GERD

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
* PPIs during last 7 days prior to study start
* Systemic glucocorticoids or non-steroidal anti-inflammatory drugs including COX-2 inhibitors during the last 28 days prior to study start; except regular intake of acetylsalicylic acid up to a daily dose of 163 mg/day
* Intake of PPIs in combination with antibiotics for eradication of H. pylori

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
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2007
Sample size
Target
Accrual to date
Final
628
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Altana Pharma/Nycomed - Bondi Junction
Recruitment hospital [2] 0 0
Altana Pharma/Nycomed - Box Hill, Victoria
Recruitment hospital [3] 0 0
Altana Pharma/Nycomed - New South Wales
Recruitment hospital [4] 0 0
Altana Pharma/Nycomed - South Australia
Recruitment postcode(s) [1] 0 0
NSW 2022 - Bondi Junction
Recruitment postcode(s) [2] 0 0
3128 - Box Hill, Victoria
Recruitment postcode(s) [3] 0 0
2138 - New South Wales
Recruitment postcode(s) [4] 0 0
5000 - South Australia
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Feldbach
Country [2] 0 0
Austria
State/province [2] 0 0
Graz
Country [3] 0 0
Austria
State/province [3] 0 0
Stockerau
Country [4] 0 0
Austria
State/province [4] 0 0
Wiener Neustadt
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Germany
State/province [6] 0 0
Amberg
Country [7] 0 0
Germany
State/province [7] 0 0
Aschersleben
Country [8] 0 0
Germany
State/province [8] 0 0
Berlin
Country [9] 0 0
Germany
State/province [9] 0 0
Freising
Country [10] 0 0
Germany
State/province [10] 0 0
Germersheim
Country [11] 0 0
Germany
State/province [11] 0 0
Grünstadt
Country [12] 0 0
Germany
State/province [12] 0 0
Jülich
Country [13] 0 0
Germany
State/province [13] 0 0
Köln
Country [14] 0 0
Germany
State/province [14] 0 0
Köthen
Country [15] 0 0
Germany
State/province [15] 0 0
Künzing
Country [16] 0 0
Germany
State/province [16] 0 0
Landsberg
Country [17] 0 0
Germany
State/province [17] 0 0
Langen
Country [18] 0 0
Germany
State/province [18] 0 0
Leipzig
Country [19] 0 0
Germany
State/province [19] 0 0
Ludwigshafen
Country [20] 0 0
Germany
State/province [20] 0 0
Lüneburg
Country [21] 0 0
Germany
State/province [21] 0 0
Mönchengladbach
Country [22] 0 0
Germany
State/province [22] 0 0
München
Country [23] 0 0
Germany
State/province [23] 0 0
Potsdam-Babelsberg
Country [24] 0 0
Germany
State/province [24] 0 0
Reinfeld
Country [25] 0 0
Germany
State/province [25] 0 0
Saarbrücken
Country [26] 0 0
Hungary
State/province [26] 0 0
Budapest
Country [27] 0 0
Hungary
State/province [27] 0 0
Györ
Country [28] 0 0
Hungary
State/province [28] 0 0
Hatvan
Country [29] 0 0
Hungary
State/province [29] 0 0
Kaposvár
Country [30] 0 0
Hungary
State/province [30] 0 0
Kistarcsa
Country [31] 0 0
Hungary
State/province [31] 0 0
Miskolc
Country [32] 0 0
Hungary
State/province [32] 0 0
Szentes
Country [33] 0 0
Hungary
State/province [33] 0 0
Vác

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerald Holtmann, Prof.
Address 0 0
Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, North Terrace, Adelaide, Australia
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00336219