Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00336219
Recruitment Status : Completed
First Posted : June 13, 2006
Last Update Posted : May 7, 2012
Information provided by:

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.

Condition or disease Intervention/treatment Phase
GERD Drug: Pantoprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 628 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COMPETITION: Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease (GERD) Symptom Changes
Study Start Date : August 2006
Primary Completion Date : November 2006
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Pantoprazole 40 mg
Drug: Pantoprazole
Symptom Assessment after treatment with Pantoprozole 40 mg

Primary Outcome Measures :
  1. symptom assessment as measured by ReQuest™ questionnaire and investigator. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator [ Time Frame: 28 days ]
  2. endoscopic healing after 28 days [ Time Frame: 28 days ]
  3. health-related quality of life after 28 days [ Time Frame: 28 days ]
  4. safety. [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00336219

Altana Pharma/Nycomed
Bondi Junction, Australia, NSW 2022
Altana Pharma/Nycomed
Box Hill, Victoria, Australia, 3128
Altana Pharma/Nycomed
New South Wales, Australia, 2138
Altana Pharma/Nycomed
South Australia, Australia, 5000
Altana Pharma/Nycomed
Feldbach, Austria, 8330
Altana Pharma/Nycomed
Graz, Austria, 8020
Altana Pharma/Nycomed
Stockerau, Austria, 2000
Altana Pharma/Nycomed
Wiener Neustadt, Austria, 2700
Altana Pharma/Nycomed
Wien, Austria, 1140
Altana Pharma/Nycomed
Amberg, Germany, 92224
Altana Pharma/Nycomed
Aschersleben, Germany, 6449
Altana Pharma/Nycomed
Berlin, Germany, 10409
Altana Pharma/Nycomed
Berlin, Germany, 12587
Altana Pharma/Nycomed
Berlin, Germany, 13581
Altana Pharma/Nycomed
Freising, Germany, 85356
Altana Pharma/Nycomed
Germersheim, Germany, 76726
Altana Pharma/Nycomed
Grünstadt, Germany, 67269
Altana Pharma/Nycomed
Jülich, Germany, 52428
Altana Pharma/Nycomed
Köln, Germany, 50999
Altana Pharma/Nycomed
Köln, Germany, 51065
Altana Pharma/Nycomed
Köthen, Germany, 6366
Altana Pharma/Nycomed
Künzing, Germany, 94550
Altana Pharma/Nycomed
Landsberg, Germany, 6188
Altana Pharma/Nycomed
Langen, Germany, 63225
Altana Pharma/Nycomed
Leipzig, Germany, 4105
Altana Pharma/Nycomed
Ludwigshafen, Germany, 67067
Altana Pharma/Nycomed
Lüneburg, Germany, 21335
Altana Pharma/Nycomed
Mönchengladbach, Germany, 41239
Altana Pharma/Nycomed
München, Germany, 80639
Altana Pharma/Nycomed
Potsdam-Babelsberg, Germany, 14482
Altana Pharma/Nycomed
Reinfeld, Germany, 23858
Altana Pharma/Nycomed
Saarbrücken, Germany, 66111
Altana Pharma/Nycomed
Budapest, Hungary, 1125
Altana Pharma/Nycomed
Györ, Hungary, 9024
Altana Pharma/Nycomed
Hatvan, Hungary, 3000
Altana Pharma/Nycomed
Kaposvár, Hungary, 7400
Altana Pharma/Nycomed
Kistarcsa, Hungary, 2143
Altana Pharma/Nycomed
Miskolc, Hungary, 3526
Altana Pharma/Nycomed
Szentes, Hungary, 6600
Altana Pharma/Nycomed
Vác, Hungary, 2601
Sponsors and Collaborators
Principal Investigator: Gerald Holtmann, Prof. Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, North Terrace, Adelaide, Australia

Responsible Party: Nycomed Identifier: NCT00336219     History of Changes
Other Study ID Numbers: BY1023/M3-343
First Posted: June 13, 2006    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: October 2008

Keywords provided by Takeda:

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action