Clinical trial NCT00561730: Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Symptoms of Non-Erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (eGERD)
Official title: Pantoprazole 20 mg/40 mg for the Treatment of Gastroesophageal Reflux Disease (GERD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: PPI (Proton Pump Inhibitor) therapy
Pantoprazole
eGERD (Erosive Gastroesophageal Reflux Disease)
NERD (Non-Erosive Reflux Disease)
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2007-11-21
Enrollment: 1995
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients

Brief summary: The aim of the study was to evaluate the effect of 7 days treatment with Pantoprazole 40 mg and 20 mg on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) in clinical practice. During the study, the patients had to complete a short version of a patient-orientated, self-assessed reflux questionnaire (ReQuest™ in Practice).


Eligibility criteria: Main inclusion criteria:

* Outpatients with erosive gastro-esophageal reflux disease (eGERD according to Los Angeles classification grade A-D) or non-erosive reflux disease (NERD)

Main exclusion criteria:

* Criteria as defined in the Summary of Product Characteristics (Chapter 4.3)

Primary outcomes:
measure: Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)
timeFrame: 7 days
measure: Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
timeFrame: 7 days
measure: Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
timeFrame: 7 days
measure: Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
timeFrame: 7 days
measure: Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)
timeFrame: 7 days
measure: Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)
timeFrame: 7 days
Secondary outcomes:
measure: Physician's Assessment of Heartburn
timeFrame: 7 days
measure: Physician's Assessment of Acid Eructation
timeFrame: 7 days
measure: Physician's Assessment of Painful Swallowing
timeFrame: 7 days
measure: Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit
timeFrame: 7 days
measure: Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit
timeFrame: 7 days
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Nycomed Deutschland GmbH
city: Ahrensburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Alfeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Altenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Altenholz
country: Germany
facility: Nycomed Deutschland GmbH
city: Ansbach
country: Germany
facility: Nycomed Deutschland GmbH
city: Augsburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Bederkesa
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Bevensen
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Essen
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Neustadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Staffelstein
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Säckingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Baden-Baden
country: Germany
facility: Nycomed Deutschland GmbH
city: Beckum
country: Germany
facility: Nycomed Deutschland GmbH
city: Bergisch Gladbach
country: Germany
facility: Nycomed Deutschland GmbH
city: Bergkamen
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Bietigheim-Bissingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Bitterfeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Bodenwerder
country: Germany
facility: Nycomed Deutschland GmbH
city: Bonn
country: Germany
facility: Nycomed Deutschland GmbH
city: Brakel
country: Germany
facility: Nycomed Deutschland GmbH
city: Brandenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Braunschweig
country: Germany
facility: Nycomed Deutschland GmbH
city: Bredstedt
country: Germany
facility: Nycomed Deutschland GmbH
city: Bremen
country: Germany
facility: Nycomed Deutschland GmbH
city: Bremen
country: Germany
facility: Nycomed Deutschland GmbH
city: Bremerhaven
country: Germany
facility: Nycomed Deutschland GmbH
city: Butzbach
country: Germany
facility: Nycomed Deutschland GmbH
city: Büdelsdorf
country: Germany
facility: Nycomed Deutschland GmbH
city: Calw
country: Germany
facility: Nycomed Deutschland GmbH
city: Castrop-Rauxel
country: Germany
facility: Nycomed Deutschland GmbH
city: Chemnitz
country: Germany
facility: Nycomed Deutschland GmbH
city: Chemnitz
country: Germany
facility: Nycomed Deutschland GmbH
city: Chemnitz
country: Germany
facility: Nycomed Deutschland GmbH
city: Chemnitz
country: Germany
facility: Nycomed Deutschland GmbH
city: Clausthal-Zellerfeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Cloppenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Coburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Cottbus
country: Germany
facility: Nycomed Deutschland GmbH
city: Crailsheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Cölbe
country: Germany
facility: Nycomed Deutschland GmbH
city: Darmstadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Darmstadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Dessau
country: Germany
facility: Nycomed Deutschland GmbH
city: Dinkelsbühl
country: Germany
facility: Nycomed Deutschland GmbH
city: Dinslaken
country: Germany
facility: Nycomed Deutschland GmbH
city: Dortmund
country: Germany
facility: Nycomed Deutschland GmbH
city: Dresden
country: Germany
facility: Nycomed Deutschland GmbH
city: Dresden
country: Germany
facility: Nycomed Deutschland GmbH
city: Dresden
country: Germany
facility: Nycomed Deutschland GmbH
city: Dresden
country: Germany
facility: Nycomed Deutschland GmbH
city: Eisenach
country: Germany
facility: Nycomed Deutschland GmbH
city: Eisenhüttenstadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Ellefeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Engelskirchen
country: Germany
facility: Nycomed Deutschland GmbH
city: Erfurt
country: Germany
facility: Nycomed Deutschland GmbH
city: Eschweiler
country: Germany
facility: Nycomed Deutschland GmbH
city: Essen
country: Germany
facility: Nycomed Deutschland GmbH
city: Essen
country: Germany
facility: Nycomed Deutschland GmbH
city: Flensburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Frankenberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Frankenthal
country: Germany
facility: Nycomed Deutschland GmbH
city: Frankfurt
country: Germany
facility: Nycomed Deutschland GmbH
city: Freiburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Freiburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Freising
country: Germany
facility: Nycomed Deutschland GmbH
city: Freudenstadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Fulda
country: Germany
facility: Nycomed Deutschland GmbH
city: Fürth
country: Germany
facility: Nycomed Deutschland GmbH
city: Gaggenau
country: Germany
facility: Nycomed Deutschland GmbH
city: Garbsen
country: Germany
facility: Nycomed Deutschland GmbH
city: Gelsenkirchen
country: Germany
facility: Nycomed Deutschland GmbH
city: Genthin
country: Germany
facility: Nycomed Deutschland GmbH
city: Gera
country: Germany
facility: Nycomed Deutschland GmbH
city: Gera
country: Germany
facility: Nycomed Deutschland GmbH
city: Goch
country: Germany
facility: Nycomed Deutschland GmbH
city: Greiz
country: Germany
facility: Nycomed Deutschland GmbH
city: Gresse
country: Germany
facility: Nycomed Deutschland GmbH
city: Grevenbroich
country: Germany
facility: Nycomed Deutschland GmbH
city: Grevesmühlen
country: Germany
facility: Nycomed Deutschland GmbH
city: Göppingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Göttingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Güstrow
country: Germany
facility: Nycomed Deutschland GmbH
city: Halberstadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Halle
country: Germany
facility: Nycomed Deutschland GmbH
city: Hamburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Hamburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Hamburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Hannover
country: Germany
facility: Nycomed Deutschland GmbH
city: Hannover
country: Germany
facility: Nycomed Deutschland GmbH
city: Hannover
country: Germany
facility: Nycomed Deutschland GmbH
city: Hardheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Harra
country: Germany
facility: Nycomed Deutschland GmbH
city: Haßloch
country: Germany
facility: Nycomed Deutschland GmbH
city: Hechingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Heide
country: Germany
facility: Nycomed Deutschland GmbH
city: Henstedt-Ulzburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Herford
country: Germany
facility: Nycomed Deutschland GmbH
city: Herne
country: Germany
facility: Nycomed Deutschland GmbH
city: Herne
country: Germany
facility: Nycomed Deutschland GmbH
city: Herrieden
country: Germany
facility: Nycomed Deutschland GmbH
city: Hildesheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Hofbieber
country: Germany
facility: Nycomed Deutschland GmbH
city: Hof
country: Germany
facility: Nycomed Deutschland GmbH
city: Johanngeorgenstadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Karlstadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Kassel
country: Germany
facility: Nycomed Deutschland GmbH
city: Kelkheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Kiel
country: Germany
facility: Nycomed Deutschland GmbH
city: Koblenz
country: Germany
facility: Nycomed Deutschland GmbH
city: Kornwestheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Kronach
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Köthen
country: Germany
facility: Nycomed Deutschland GmbH
city: Künzing
country: Germany
facility: Nycomed Deutschland GmbH
city: Landstuhl
country: Germany
facility: Nycomed Deutschland GmbH
city: Lebach
country: Germany
facility: Nycomed Deutschland GmbH
city: Leinfelden-Echterdingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Leipzig
country: Germany
facility: Nycomed Deutschland GmbH
city: Leipzig
country: Germany
facility: Nycomed Deutschland GmbH
city: Leipzig
country: Germany
facility: Nycomed Deutschland GmbH
city: Leipzig
country: Germany
facility: Nycomed Deutschland GmbH
city: Leipzig
country: Germany
facility: Nycomed Deutschland GmbH
city: Leisnig
country: Germany
facility: Nycomed Deutschland GmbH
city: Leverkusen
country: Germany
facility: Nycomed Deutschland GmbH
city: Lichtenfels
country: Germany
facility: Nycomed Deutschland GmbH
city: Lingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Ludwigsburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Ludwigsfelde
country: Germany
facility: Nycomed Deutschland GmbH
city: Ludwigshafen
country: Germany
facility: Nycomed Deutschland GmbH
city: Ludwigslust
country: Germany
facility: Nycomed Deutschland GmbH
city: Lutherstadt Wittenberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Lübeck (Travemünde)
country: Germany
facility: Nycomed Deutschland GmbH
city: Lübeck
country: Germany
facility: Nycomed Deutschland GmbH
city: Lübeck
country: Germany
facility: Nycomed Deutschland GmbH
city: Lüdenscheid
country: Germany
facility: Nycomed Deutschland GmbH
city: Lüneburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Lützen
country: Germany
facility: Nycomed Deutschland GmbH
city: Magdeburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Mainz
country: Germany
facility: Nycomed Deutschland GmbH
city: Mannheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Mannheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Marburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Marienberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Marl
country: Germany
facility: Nycomed Deutschland GmbH
city: Mayen
country: Germany
facility: Nycomed Deutschland GmbH
city: Merseburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Merzig
country: Germany
facility: Nycomed Deutschland GmbH
city: Minden
country: Germany
facility: Nycomed Deutschland GmbH
city: Minden
country: Germany
facility: Nycomed Deutschland GmbH
city: Möckmühl
country: Germany
facility: Nycomed Deutschland GmbH
city: Mönchengladbach
country: Germany
facility: Nycomed Deutschland GmbH
city: München
country: Germany
facility: Nycomed Deutschland GmbH
city: München
country: Germany
facility: Nycomed Deutschland GmbH
city: München
country: Germany
facility: Nycomed Deutschland GmbH
city: München
country: Germany
facility: Nycomed Deutschland GmbH
city: München
country: Germany
facility: Nycomed Deutschland GmbH
city: Münzenberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Neckargemünd
country: Germany
facility: Nycomed Deutschland GmbH
city: Neu Wulmstorf
country: Germany
facility: Nycomed Deutschland GmbH
city: Neu-Isenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Neubiberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Neukirchen
country: Germany
facility: Nycomed Deutschland GmbH
city: Neustadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Neuwied
country: Germany
facility: Nycomed Deutschland GmbH
city: Nieder-Olm
country: Germany
facility: Nycomed Deutschland GmbH
city: Nienburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Nordhorn
country: Germany
facility: Nycomed Deutschland GmbH
city: Nürnberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Nürnberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Nürnberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Oberhausen
country: Germany
facility: Nycomed Deutschland GmbH
city: Oberndorf
country: Germany
facility: Nycomed Deutschland GmbH
city: Ochsenfurt
country: Germany
facility: Nycomed Deutschland GmbH
city: Oelsnitz
country: Germany
facility: Nycomed Deutschland GmbH
city: Oschatz
country: Germany
facility: Nycomed Deutschland GmbH
city: Oschersleben
country: Germany
facility: Nycomed Deutschland GmbH
city: Osnabrück
country: Germany
facility: Nycomed Deutschland GmbH
city: Paderborn
country: Germany
facility: Nycomed Deutschland GmbH
city: Papenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Peine
country: Germany
facility: Nycomed Deutschland GmbH
city: Penig
country: Germany
facility: Nycomed Deutschland GmbH
city: Pfullingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Pirna
country: Germany
facility: Nycomed Deutschland GmbH
city: Plauen
country: Germany
facility: Nycomed Deutschland GmbH
city: Plauen
country: Germany
facility: Nycomed Deutschland GmbH
city: Potsdam
country: Germany
facility: Nycomed Deutschland GmbH
city: Potsdam
country: Germany
facility: Nycomed Deutschland GmbH
city: Recklinghausen
country: Germany
facility: Nycomed Deutschland GmbH
city: Regensburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Reichenbach
country: Germany
facility: Nycomed Deutschland GmbH
city: Remscheid
country: Germany
facility: Nycomed Deutschland GmbH
city: Rendsburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Reutlingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Riesa
country: Germany
facility: Nycomed Deutschland GmbH
city: Roetgen
country: Germany
facility: Nycomed Deutschland GmbH
city: Rostock
country: Germany
facility: Nycomed Deutschland GmbH
city: Rottach-Egern
country: Germany
facility: Nycomed Deutschland GmbH
city: Rottweil
country: Germany
facility: Nycomed Deutschland GmbH
city: Saarbrücken
country: Germany
facility: Nycomed Deutschland GmbH
city: Saarlouis
country: Germany
facility: Nycomed Deutschland GmbH
city: Salzgitter
country: Germany
facility: Nycomed Deutschland GmbH
city: Salzmünde
country: Germany
facility: Nycomed Deutschland GmbH
city: Sangerhausen
country: Germany
facility: Nycomed Deutschland GmbH
city: Sarstedt
country: Germany
facility: Nycomed Deutschland GmbH
city: Schiffweiler
country: Germany
facility: Nycomed Deutschland GmbH
city: Schmalkalden
country: Germany
facility: Nycomed Deutschland GmbH
city: Schwedt
country: Germany
facility: Nycomed Deutschland GmbH
city: Schwerin
country: Germany
facility: Nycomed Deutschland GmbH
city: Schwäbisch Hall
country: Germany
facility: Nycomed Deutschland GmbH
city: Schönwalde-Glien
country: Germany
facility: Nycomed Deutschland GmbH
city: Siegen
country: Germany
facility: Nycomed Deutschland GmbH
city: Sinsheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Spaichingen
country: Germany
facility: Nycomed Deutschland GmbH
city: St. Blasien
country: Germany
facility: Nycomed Deutschland GmbH
city: Steinfurt
country: Germany
facility: Nycomed Deutschland GmbH
city: Steißlingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Stockach
country: Germany
facility: Nycomed Deutschland GmbH
city: Strausberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Stuhr
country: Germany
facility: Nycomed Deutschland GmbH
city: Sundern
country: Germany
facility: Nycomed Deutschland GmbH
city: Teuchern
country: Germany
facility: Nycomed Deutschland GmbH
city: Trier
country: Germany
facility: Nycomed Deutschland GmbH
city: Trittau
country: Germany
facility: Nycomed Deutschland GmbH
city: Tönisvorst
country: Germany
facility: Nycomed Deutschland GmbH
city: Varel
country: Germany
facility: Nycomed Deutschland GmbH
city: Waghäusel
country: Germany
facility: Nycomed Deutschland GmbH
city: Wangen
country: Germany
facility: Nycomed Deutschland GmbH
city: Wanzleben
country: Germany
facility: Nycomed Deutschland GmbH
city: Weißwasser
country: Germany
facility: Nycomed Deutschland GmbH
city: Westerkappeln
country: Germany
facility: Nycomed Deutschland GmbH
city: Weyhe
country: Germany
facility: Nycomed Deutschland GmbH
city: Wiesbaden
country: Germany
facility: Nycomed Deutschland GmbH
city: Wiesbaden
country: Germany
facility: Nycomed Deutschland GmbH
city: Wiesbaden
country: Germany
facility: Nycomed Deutschland GmbH
city: Wiesloch
country: Germany
facility: Nycomed Deutschland GmbH
city: Willich
country: Germany
facility: Nycomed Deutschland GmbH
city: Winsen
country: Germany
facility: Nycomed Deutschland GmbH
city: Wismar
country: Germany
facility: Nycomed Deutschland GmbH
city: Wittstock
country: Germany
facility: Nycomed Deutschland GmbH
city: Wolfsburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Worms
country: Germany
facility: Nycomed Deutschland GmbH
city: Wäschenbeuren
country: Germany
facility: Nycomed Deutschland GmbH
city: Würzburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Zerbst
country: Germany
facility: Nycomed Deutschland GmbH
city: Zweibrücken
country: Germany
facility: Nycomed Deutschland GmbH
city: Zwickau
country: Germany
facility: Nycomed Deutschland GmbH
Study officials:
affiliation: Nycomed Deutschland GmbH, 78467 Konstanz, Germany
name: Dr. Thomas D. Bethke, MD, MBA
role: STUDY_DIRECTOR
References: