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

Purpose

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	Intervention	Phase
GERD	Drug: Pantoprazole	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	COMPETITION: Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease (GERD) Symptom Changes

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy GERD

Drug Information available for: Pantoprazole Pantoprazole sodium

U.S. FDA Resources

Further study details as provided by Takeda:

Primary Outcome Measures:

symptom assessment as measured by ReQuest™ questionnaire and investigator. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator [ Time Frame: 28 days ] [ Designated as safety issue: No ]
endoscopic healing after 28 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
health-related quality of life after 28 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
safety. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment:	628
Study Start Date:	August 2006
Study Completion Date:	April 2007
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Pantoprazole 40 mg	Drug: Pantoprazole Symptom Assessment after treatment with Pantoprozole 40 mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336219

Locations

Australia
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
Austria
Altana Pharma/Nycomed
Feldbach, Austria, 8330
Altana Pharma/Nycomed
Graz, Austria, 8020
Altana Pharma/Nycomed
Stockerau, Austria, 2000
Altana Pharma/Nycomed
Wien, Austria, 1140
Altana Pharma/Nycomed
Wiener Neustadt, Austria, 2700
Germany
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
Hungary
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

Takeda

Investigators

Principal Investigator:

Gerald Holtmann, Prof.

Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, North Terrace, Adelaide, Australia

More Information

No publications provided

Responsible Party:	Nycomed
ClinicalTrials.gov Identifier:	NCT00336219 History of Changes
Other Study ID Numbers:	BY1023/M3-343
Study First Received:	June 12, 2006
Last Updated:	May 4, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Takeda:

GERD
Pantoprazole

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole

Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013