Efficacy of Pantoprazole 20/40 mg Once Daily (od) in Patients Older Than 12 Years Who Have Gastrointestinal Symptoms of Reflux Disease

Study Overview
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Brief Summary
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The aim of this study was to evaluate the effect of 14 days treatment with Pantoprazole 40 mg and 20 mg on gastroesophageal reflux disease (GERD) related symptoms in a large patient population.

Official Title
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Pantoprazole 20/40 mg in Reflux-Associated Complaints With Focus on Gastrointestinal Symptoms

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 gastroesophageal reflux disease (GERD) Main exclusion criteria: Criteria as defined in the Summary of Product Characteristics

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 |
| --- | --- |
| Group 1<br>All patients enrolled | Drug: Pantoprazole<br>* This was an observational study. Therefore, the physician decided about dosage according to individual needs (20 or 40 mg pantoprazole).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | 14 days | 
| Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | 14 days | 
| Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | 14 days | 
| Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms | Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | 14 days | 
| Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | 14 days | 
| Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | 14 days | 
| Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms | Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory | 14 days | 
| Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | 14 days | 
| Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | 14 days | 
| Irritable Bowel Syndrome: Assessment of the Severity of Constipation | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | 14 days | 
| Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome | Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory | 14 days | 
| Assessment of the Tolerability of Pantoprazole at Final Visit | Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PPI therapy, pantoprazole, GERD (Erosive Gastroesophageal Reflux Disease)