Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders - Tabular View

Tracking Information

First Received Date ^ICMJE

January 13, 2009

Last Updated Date

June 9, 2009

Start Date ^ICMJE

January 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Investigation of GERD-associated sleep disorders and how they are influenced by PPI therapy [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Prevalence and intensity will be documented by a standardized questionnaire [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00830115 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Prevalence of eGERD and NERD (ratio) [ Time Frame: before treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The aim of the study is 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 will be evaluated by a standardized questionnaire. The study will provide further data on safety and tolerability of pantoprazole.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Condition ^ICMJE

Sleep Disorders
Non-Erosive Reflux Disease
Gastroesophageal Reflux Disease

Intervention ^ICMJE

Drug: Pantoprazole

This is an observational study. Therefore, the physician decides about dosage according to individual needs (20 or 40 mg pantoprazole).

Study Arms / Comparison Groups

Panda

Intervention: Drug: Pantoprazole

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1200

Completion Date

June 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Main inclusion criteria:

Patients with gastro-esophageal reflux disease (GERD)

Main exclusion criteria:

Criteria as defined in the respective Summary of Product Characteristics (Fachinformation Chapter 4.3)

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00830115

Responsible Party

Medical Director, Nycomed Deutschland GmbH

Study ID Numbers ^ICMJE

P2-9999-010-DE

Study Sponsor ^ICMJE

Nycomed

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Thomas Bethke, MD, MBA

Nycomed Deutschland GmbH, 78467 Konstanz, Germany

Information Provided By

Nycomed

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP