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

Completed

• Conditions: Gastroesophageal Reflux Disease; Sleep Disorders; Non-Erosive Reflux Disease
• Interventions: Drug: Pantoprazole

• Registration Number: NCT00830115
• Lead Sponsor: Nycomed

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Primary Completion: 2009-05
• Study Completion: 2009-06
• Results First Submitted: 2010-07-20
• Results First Submitted QC: 2010-08-20
• Results First Posted: 2010-09-15
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1045

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pantoprazole	Pantoprazole	All patients enrolled

Primary Outcome Measures

Name	Time	Method
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)	7 days	Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Physician's Assessment of Sleep Disturbances	7 days	Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)	7 days	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

Secondary Outcome Measures

Name	Time	Method
Patient's Assessment of Nausea for the Last 24 Hours (Diaries)	7 days	Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Physician's Assessment of Heartburn	7 days	Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)	7 days	Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)	7 days	Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)	7 days	Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)	7 days	Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Physician's Assessment of Acid Eructation	7 days	Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Physician's Assessment of Painful Swallowing	7 days	Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Assessment of the Efficacy of Pantoprazole at Final Visit	7 days	Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Assessment of the Tolerability of Pantoprazole at Final Visit	7 days	Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Trial Locations

Locations (1)

Nycomed Deutschland GmbH; 🇩🇪 Zwickau, Germany