Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders

Conditions
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Sleep Disorders, Non-Erosive Reflux Disease, Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Pantoprazole


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pantoprazole<br>All patients enrolled | Drug: Pantoprazole<br>* Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 7 days | 
| Physician's Assessment of Sleep Disturbances | Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 7 days | 
| Patient's Assessment of Nausea for the Last 24 Hours (Diaries) | Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired | 7 days | 
| Physician's Assessment of Heartburn | Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe | 7 days | 
| Physician's Assessment of Acid Eructation | Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe | 7 days | 
| Physician's Assessment of Painful Swallowing | Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe | 7 days | 
| Assessment of the Efficacy of Pantoprazole at Final Visit | Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory | 7 days | 
| Assessment of the Tolerability of Pantoprazole at Final Visit | Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PPI therapy, Pantoprazole, eGERD (Erosive Gastroesophageal Reflux Disease), NERD (Non-Erosive Reflux Disease)