Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS)

Study Overview
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Brief Summary
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The aim of the study was to evaluate the effect of Pantoprazole 20 mg/40 mg for 14 days on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) with special focus on the reduction of symptomatic sleep disorders.

Official Title
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Pantoprazole for the Treatment of GERD Associated Symptoms Focusing on Sleep Disorders.

Conditions
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Erosive Gastroesophageal Reflux Disease, Non-Erosive 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: GERD NERD 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 |
| --- | --- |
| Pantoprazole<br> | Drug: Pantoprazole<br>* This was an observational study. Therefore, the physician decided about dosage according to individual needs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the Severity of Sleep Disturbances | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | first and last visit (after a median of 18 days) | 
| Assessment of Change of Quality of Sleep During Therapy With Pantoprazole | Physician's assessment on a scale with considerably improved improved unchanged | last visit (after a median of 18 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the Severity of Heartburn | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | first and last visit (after a median of 18 days) | 
| Assessment of the Severity of Eructation/Acid Eructation | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | first and last visit (after a median of 18 days) | 
| Assessment of the Severity of Epigastric Complaints/Epigastric Pain | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | first and last visit (after a median of 18 days) | 
| Assessment of the Severity of Sensation of Fullness/Abdominal Distension | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe | first and last visit (after a median of 18 days) | 
| Assessment of the Efficacy of Pantoprazole at Final Visit | Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory | last visit (after a median of 18 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 | last visit (after a median of 18 days) | 

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