Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Symptoms of Non-Erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (eGERD)

Study Overview
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Brief Summary
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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).

Official Title
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Pantoprazole 20 mg/40 mg for the Treatment of Gastroesophageal Reflux Disease (GERD)

Conditions
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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 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)

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 General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice) | Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad | 7 days | 
| Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) | Assessment on a scale: Severity from 0=None to 10=Extremely strong | 7 days | 
| Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) | Assessment on a scale: Severity from 0=None to 10=Extremely strong | 7 days | 
| Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) | Assessment on a scale: Severity from 0=None to 10=Extremely strong | 7 days | 
| Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice) | Assessment on a scale: Severity from 0=None to 10=Extremely strong | 7 days | 
| Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice) | Assessment on a scale: Severity from 0=None to 10=Extremely strong | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 20 mg/40 mg at Final Visit | Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory | 7 days | 
| Assessment of the Tolerability of Pantoprazole 20 mg/40 mg 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 (Proton Pump Inhibitor) therapy, Pantoprazole, eGERD (Erosive Gastroesophageal Reflux Disease), NERD (Non-Erosive Reflux Disease)