Clinical trial NCT00336219: Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)
Official title: COMPETITION: Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease (GERD) Symptom Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: GERD
Keywords: GERD
Pantoprazole
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2006-06-13
Enrollment: 628
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: symptom assessment as measured by ReQuest™ questionnaire and investigator.
timeFrame: 28 days
Secondary outcomes:
measure: symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator
timeFrame: 28 days
measure: endoscopic healing after 28 days
timeFrame: 28 days
measure: health-related quality of life after 28 days
timeFrame: 28 days
measure: safety.
timeFrame: 28 days
Other outcomes:
Locations:
city: Bondi Junction
country: Australia
facility: Altana Pharma/Nycomed
city: Box Hill, Victoria
country: Australia
facility: Altana Pharma/Nycomed
city: New South Wales
country: Australia
facility: Altana Pharma/Nycomed
city: South Australia
country: Australia
facility: Altana Pharma/Nycomed
city: Feldbach
country: Austria
facility: Altana Pharma/Nycomed
city: Graz
country: Austria
facility: Altana Pharma/Nycomed
city: Stockerau
country: Austria
facility: Altana Pharma/Nycomed
city: Wiener Neustadt
country: Austria
facility: Altana Pharma/Nycomed
city: Wien
country: Austria
facility: Altana Pharma/Nycomed
city: Amberg
country: Germany
facility: Altana Pharma/Nycomed
city: Aschersleben
country: Germany
facility: Altana Pharma/Nycomed
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed
city: Freising
country: Germany
facility: Altana Pharma/Nycomed
city: Germersheim
country: Germany
facility: Altana Pharma/Nycomed
city: Grünstadt
country: Germany
facility: Altana Pharma/Nycomed
city: Jülich
country: Germany
facility: Altana Pharma/Nycomed
city: Köln
country: Germany
facility: Altana Pharma/Nycomed
city: Köln
country: Germany
facility: Altana Pharma/Nycomed
city: Köthen
country: Germany
facility: Altana Pharma/Nycomed
city: Künzing
country: Germany
facility: Altana Pharma/Nycomed
city: Landsberg
country: Germany
facility: Altana Pharma/Nycomed
city: Langen
country: Germany
facility: Altana Pharma/Nycomed
city: Leipzig
country: Germany
facility: Altana Pharma/Nycomed
city: Ludwigshafen
country: Germany
facility: Altana Pharma/Nycomed
city: Lüneburg
country: Germany
facility: Altana Pharma/Nycomed
city: Mönchengladbach
country: Germany
facility: Altana Pharma/Nycomed
city: München
country: Germany
facility: Altana Pharma/Nycomed
city: Potsdam-Babelsberg
country: Germany
facility: Altana Pharma/Nycomed
city: Reinfeld
country: Germany
facility: Altana Pharma/Nycomed
city: Saarbrücken
country: Germany
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Györ
country: Hungary
facility: Altana Pharma/Nycomed
city: Hatvan
country: Hungary
facility: Altana Pharma/Nycomed
city: Kaposvár
country: Hungary
facility: Altana Pharma/Nycomed
city: Kistarcsa
country: Hungary
facility: Altana Pharma/Nycomed
city: Miskolc
country: Hungary
facility: Altana Pharma/Nycomed
city: Szentes
country: Hungary
facility: Altana Pharma/Nycomed
city: Vác
country: Hungary
facility: Altana Pharma/Nycomed
Study officials:
affiliation: Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, North Terrace, Adelaide, Australia
name: Gerald Holtmann, Prof.
role: PRINCIPAL_INVESTIGATOR
References: