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

Sponsor:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00830115

Purpose

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.

Condition	Intervention
Sleep Disorders Non-Erosive Reflux Disease Gastroesophageal Reflux Disease	Drug: Pantoprazole

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders

Resource links provided by NLM:

MedlinePlus related topics: GERD Sleep Disorders

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Further study details as provided by Nycomed:

Primary Outcome Measures:

Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
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
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Physician's Assessment of Sleep Disturbances [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

Secondary Outcome Measures:

Patient's Assessment of General Well-being for the Last 24 Hours (Diaries) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
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) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
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) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Patient's Assessment of Nausea for the Last 24 Hours (Diaries) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Physician's Assessment of Heartburn [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Physician's Assessment of Acid Eructation [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Physician's Assessment of Painful Swallowing [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Assessment of the Efficacy of Pantoprazole at Final Visit [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Assessment of the Tolerability of Pantoprazole at Final Visit [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Enrollment:	1045
Study Start Date:	January 2009
Study Completion Date:	June 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Pantoprazole All patients enrolled	Drug: Pantoprazole Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Outpatients

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830115

Show 201 Study Locations

Sponsors and Collaborators

Nycomed

Investigators

Study Director:

Thomas Bethke, MD, MBA

Nycomed Deutschland GmbH, 78467 Konstanz, Germany

More Information

No publications provided

Responsible Party:	Medical Director, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier:	NCT00830115 History of Changes
Other Study ID Numbers:	P2-9999-010-DE
Study First Received:	January 13, 2009
Results First Received:	July 20, 2010
Last Updated:	August 20, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed:

PPI therapy
Pantoprazole
eGERD (Erosive Gastroesophageal Reflux Disease)
NERD (Non-Erosive Reflux Disease)

Additional relevant MeSH terms:

Gastroesophageal Reflux
Sleep Disorders
Parasomnias
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nervous System Diseases
Neurologic Manifestations

Signs and Symptoms
Mental Disorders
Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012