Trials Sponsors Conditions Drugs Pricing

Conditions

Gastroesophageal Reflux Disease Non-Erosive Reflux Disease Sleep Disorders

Keywords

PPI therapyPantoprazoleeGERD (Erosive Gastroesophageal Reflux Disease)NERD (Non-Erosive Reflux Disease)

Outcome Measures

Primary Outcomes (3)

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

Study Arms (1)

Pantoprazole

All patients enrolled

Drug: Pantoprazole

Interventions

PantoprazoleDrug

Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).

Pantoprazole

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Outpatients

You may qualify if:

Outpatients with erosive gastro-esophageal reflux disease (eGERD) or non-erosive reflux disease (NERD)

You may not qualify if:

Sponsors & Collaborators

Nycomed
Industrylead

Study Sites (201)

Nycomed Deutschland GmbH

Aachen, 52078, Germany

Nycomed Deutschland GmbH

Ahrensburg, 22926, Germany

Nycomed Deutschland GmbH

Altenburg, 04600, Germany

Nycomed Deutschland GmbH

Ansbach, 91522, Germany

Nycomed Deutschland GmbH

Aschaffenburg, 63739, Germany

Nycomed Deutschland GmbH

Augsburg, 86150, Germany

Nycomed Deutschland GmbH

Bad Bederkesa, 27624, Germany

MeSH Terms

Conditions

Sleep Wake DisordersNon-Erosive Reflux DiseaseGastroesophageal Reflux

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title: Medical Responsible
Organization: Nycomed Deutschland GmbH

Study Officials

Thomas Bethke, MD, MBA
Nycomed Deutschland GmbH, 78467 Konstanz, Germany
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

1,045 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 27, 2009

Study Start

January 2009

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Pantoprazole

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (201)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (10)

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Pantoprazole

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (201)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (10)

Intervention Hierarchy (Ancestors)

Source record

Locations