Clinical trial NCT00830115: Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders
Official title: Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders
Non-Erosive Reflux Disease
Gastroesophageal Reflux Disease
Keywords: PPI therapy
Pantoprazole
eGERD (Erosive Gastroesophageal Reflux Disease)
NERD (Non-Erosive Reflux Disease)
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2009-01-27
Enrollment: 1045
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 pantoprazole on sleep disorders in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease). The prevalence and intensity of the sleep disorders were evaluated by a standardized questionnaire. The study was expected to provide further data on safety and tolerability of pantoprazole.


Eligibility criteria: Main inclusion criteria:

* Outpatients with erosive gastro-esophageal reflux disease (eGERD) or non-erosive reflux disease (NERD)

Main exclusion criteria:

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

Primary outcomes:
measure: Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
timeFrame: 7 days
measure: Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
timeFrame: 7 days
measure: Physician's Assessment of Sleep Disturbances
timeFrame: 7 days
Secondary outcomes:
measure: Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)
timeFrame: 7 days
measure: Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)
timeFrame: 7 days
measure: Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)
timeFrame: 7 days
measure: Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)
timeFrame: 7 days
measure: Patient's Assessment of Nausea for the Last 24 Hours (Diaries)
timeFrame: 7 days
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 at Final Visit
timeFrame: 7 days
measure: Assessment of the Tolerability of Pantoprazole 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: Altenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Ansbach
country: Germany
facility: Nycomed Deutschland GmbH
city: Aschaffenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Augsburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Doberan
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Essen
country: Germany
facility: Nycomed Deutschland GmbH
city: Bad Kissigen
country: Germany
facility: Nycomed Deutschland GmbH
city: Bassum
country: Germany
facility: Nycomed Deutschland GmbH
city: Beckum-Neubeckum
country: Germany
facility: Nycomed Deutschland GmbH
city: Bederkesa
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: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Bietigheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Bitterfeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Bochum
country: Germany
facility: Nycomed Deutschland GmbH
city: Bochum
country: Germany
facility: Nycomed Deutschland GmbH
city: Bodenwerder
country: Germany
facility: Nycomed Deutschland GmbH
city: Bovenden
country: Germany
facility: Nycomed Deutschland GmbH
city: Bramsche
country: Germany
facility: Nycomed Deutschland GmbH
city: Brandenburg
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: 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: Clenze
country: Germany
facility: Nycomed Deutschland GmbH
city: Coburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Cottbus
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: Deggendorf
country: Germany
facility: Nycomed Deutschland GmbH
city: Dessau
country: Germany
facility: Nycomed Deutschland GmbH
city: Dinkelsbühl
country: Germany
facility: Nycomed Deutschland GmbH
city: Dippoldswalde
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: Ellefeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Erfurt
country: Germany
facility: Nycomed Deutschland GmbH
city: Erlenbach
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: Esslingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Flensburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Frankfurt
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: Fürstenzell
country: Germany
facility: Nycomed Deutschland GmbH
city: Fürth
country: Germany
facility: Nycomed Deutschland GmbH
city: Gardelegen
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: Goslar
country: Germany
facility: Nycomed Deutschland GmbH
city: Greifsfeld
country: Germany
facility: Nycomed Deutschland GmbH
city: Greifswald
country: Germany
facility: Nycomed Deutschland GmbH
city: Grevenbroich
country: Germany
facility: Nycomed Deutschland GmbH
city: Grimmen
country: Germany
facility: Nycomed Deutschland GmbH
city: Großaitingen
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: Harra
country: Germany
facility: Nycomed Deutschland GmbH
city: Haßfurt
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: Hildesheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Hof
country: Germany
facility: Nycomed Deutschland GmbH
city: Holzgerlingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Ibbenbüren
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: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: L.-E.-Musberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Landstuhl
country: Germany
facility: Nycomed Deutschland GmbH
city: Leer
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: Leverkusen
country: Germany
facility: Nycomed Deutschland GmbH
city: Lichtenfels
country: Germany
facility: Nycomed Deutschland GmbH
city: Limburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Lingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Ludwigsfelde
country: Germany
facility: Nycomed Deutschland GmbH
city: Ludwigshafen
country: Germany
facility: Nycomed Deutschland GmbH
city: Ludwigshaven-Oggersheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Lutherstadt Wittenberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Lübeck
country: Germany
facility: Nycomed Deutschland GmbH
city: Lüdenscheid
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: Marienberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Marl
country: Germany
facility: Nycomed Deutschland GmbH
city: Merseburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Merzig-Schwemlingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Mettlach
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: Mönchnegladbach
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: Neukirchen
country: Germany
facility: Nycomed Deutschland GmbH
city: Neuruppin
country: Germany
facility: Nycomed Deutschland GmbH
city: Neustadt i. Sa.
country: Germany
facility: Nycomed Deutschland GmbH
city: Neustadt/Orla
country: Germany
facility: Nycomed Deutschland GmbH
city: Nieder-Olm
country: Germany
facility: Nycomed Deutschland GmbH
city: Nordhausen
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/Erzgeb.
country: Germany
facility: Nycomed Deutschland GmbH
city: Oldenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Paderborn
country: Germany
facility: Nycomed Deutschland GmbH
city: Papenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Penig
country: Germany
facility: Nycomed Deutschland GmbH
city: Plauen
country: Germany
facility: Nycomed Deutschland GmbH
city: Plettenberg
country: Germany
facility: Nycomed Deutschland GmbH
city: Potsdam
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: Remscheid
country: Germany
facility: Nycomed Deutschland GmbH
city: Riesa
country: Germany
facility: Nycomed Deutschland GmbH
city: Rostock
country: Germany
facility: Nycomed Deutschland GmbH
city: Rottach
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: Schiffweiler
country: Germany
facility: Nycomed Deutschland GmbH
city: Schmalkalden
country: Germany
facility: Nycomed Deutschland GmbH
city: Schwarmstedt
country: Germany
facility: Nycomed Deutschland GmbH
city: Schwerin
country: Germany
facility: Nycomed Deutschland GmbH
city: Schwäbisch Hall
country: Germany
facility: Nycomed Deutschland GmbH
city: Sondeshausen
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: Sundern
country: Germany
facility: Nycomed Deutschland GmbH
city: Tapfheim
country: Germany
facility: Nycomed Deutschland GmbH
city: Varel
country: Germany
facility: Nycomed Deutschland GmbH
city: Waghäusel 3
country: Germany
facility: Nycomed Deutschland GmbH
city: Wangen
country: Germany
facility: Nycomed Deutschland GmbH
city: Wanzleben
country: Germany
facility: Nycomed Deutschland GmbH
city: Weißenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Weißenfels
country: Germany
facility: Nycomed Deutschland GmbH
city: Wiesbaden
country: Germany
facility: Nycomed Deutschland GmbH
city: Willich
country: Germany
facility: Nycomed Deutschland GmbH
city: Wismar
country: Germany
facility: Nycomed Deutschland GmbH
city: Zell
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: Thomas Bethke, MD, MBA
role: STUDY_DIRECTOR
References: