Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)
May 4, 2012 updated by: Takeda
COMPETITION: Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease (GERD) Symptom Changes
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
628
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bondi Junction, Australia, NSW 2022
- Altana Pharma/Nycomed
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Box Hill, Victoria, Australia, 3128
- Altana Pharma/Nycomed
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New South Wales, Australia, 2138
- Altana Pharma/Nycomed
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South Australia, Australia, 5000
- Altana Pharma/Nycomed
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Feldbach, Austria, 8330
- Altana Pharma/Nycomed
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Graz, Austria, 8020
- Altana Pharma/Nycomed
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Stockerau, Austria, 2000
- Altana Pharma/Nycomed
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Wien, Austria, 1140
- Altana Pharma/Nycomed
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Wiener Neustadt, Austria, 2700
- Altana Pharma/Nycomed
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Amberg, Germany, 92224
- Altana Pharma/Nycomed
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Aschersleben, Germany, 6449
- Altana Pharma/Nycomed
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Berlin, Germany, 10409
- Altana Pharma/Nycomed
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Berlin, Germany, 12587
- Altana Pharma/Nycomed
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Berlin, Germany, 13581
- Altana Pharma/Nycomed
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Freising, Germany, 85356
- Altana Pharma/Nycomed
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Germersheim, Germany, 76726
- Altana Pharma/Nycomed
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Grünstadt, Germany, 67269
- Altana Pharma/Nycomed
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Jülich, Germany, 52428
- Altana Pharma/Nycomed
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Köln, Germany, 50999
- Altana Pharma/Nycomed
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Köln, Germany, 51065
- Altana Pharma/Nycomed
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Köthen, Germany, 6366
- Altana Pharma/Nycomed
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Künzing, Germany, 94550
- Altana Pharma/Nycomed
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Landsberg, Germany, 6188
- Altana Pharma/Nycomed
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Langen, Germany, 63225
- Altana Pharma/Nycomed
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Leipzig, Germany, 4105
- Altana Pharma/Nycomed
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Ludwigshafen, Germany, 67067
- Altana Pharma/Nycomed
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Lüneburg, Germany, 21335
- Altana Pharma/Nycomed
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Mönchengladbach, Germany, 41239
- Altana Pharma/Nycomed
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München, Germany, 80639
- Altana Pharma/Nycomed
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Potsdam-Babelsberg, Germany, 14482
- Altana Pharma/Nycomed
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Reinfeld, Germany, 23858
- Altana Pharma/Nycomed
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Saarbrücken, Germany, 66111
- Altana Pharma/Nycomed
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Budapest, Hungary, 1125
- Altana Pharma/Nycomed
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Györ, Hungary, 9024
- Altana Pharma/Nycomed
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Hatvan, Hungary, 3000
- Altana Pharma/Nycomed
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Kaposvár, Hungary, 7400
- Altana Pharma/Nycomed
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Kistarcsa, Hungary, 2143
- Altana Pharma/Nycomed
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Miskolc, Hungary, 3526
- Altana Pharma/Nycomed
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Szentes, Hungary, 6600
- Altana Pharma/Nycomed
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Vác, Hungary, 2601
- Altana Pharma/Nycomed
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Main Inclusion Criteria:
- 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 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 1
Pantoprazole 40 mg
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Symptom Assessment after treatment with Pantoprozole 40 mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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symptom assessment as measured by ReQuest™ questionnaire and investigator.
Time Frame: 28 days
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28 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator
Time Frame: 28 days
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28 days
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endoscopic healing after 28 days
Time Frame: 28 days
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28 days
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health-related quality of life after 28 days
Time Frame: 28 days
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28 days
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safety.
Time Frame: 28 days
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gerald Holtmann, Prof., Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, North Terrace, Adelaide, Australia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
June 12, 2006
First Submitted That Met QC Criteria
June 12, 2006
First Posted (Estimate)
June 13, 2006
Study Record Updates
Last Update Posted (Estimate)
May 7, 2012
Last Update Submitted That Met QC Criteria
May 4, 2012
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BY1023/M3-343
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.