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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux
disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An
endoscopy will be performed at study start and study end. During the study, the patients will
complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire).
The study duration consists of a baseline period (8 days) and treatment period (28 days).
Pantoprazole (tablet) will be administered once daily at one dose level. The study will
provide further data on safety and tolerability of pantoprazole.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00336219
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00336219