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.
Study Type
OBSERVATIONAL
Enrollment
1,045
Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).
Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts
Time frame: 7 days
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Time frame: 7 days
Physician's Assessment of Sleep Disturbances
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 7 days
Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad
Time frame: 7 days
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Time frame: 7 days
Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Time frame: 7 days
Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Time frame: 7 days
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Nycomed Deutschland GmbH
Aachen, Germany
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Ahrensburg, Germany
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Altenburg, Germany
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Ansbach, Germany
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Aschaffenburg, Germany
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Augsburg, Germany
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Bad Bederkesa, Germany
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Bad Doberan, Germany
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Bad Essen, Germany
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Bad Kissigen, Germany
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Patient's Assessment of Nausea for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Time frame: 7 days
Physician's Assessment of Heartburn
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 7 days
Physician's Assessment of Acid Eructation
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 7 days
Physician's Assessment of Painful Swallowing
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Time frame: 7 days
Assessment of the Efficacy of Pantoprazole at Final Visit
Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Time frame: 7 days
Assessment of the Tolerability of Pantoprazole at Final Visit
Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Time frame: 7 days