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

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

Purpose

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.

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

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on 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:

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 ]

Secondary Outcome Measures:

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1200
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
Panda	Drug: Pantoprazole This is an observational study. Therefore, the physician decides about dosage according to individual needs (20 or 40 mg pantoprazole).

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:

Patients with gastro-esophageal reflux disease (GERD)

Main exclusion criteria:

Criteria as defined in the respective Summary of Product Characteristics (Fachinformation 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:	Nycomed Deutschland GmbH ( Medical Director )
Study ID Numbers:	P2-9999-010-DE
Study First Received:	January 13, 2009
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00830115 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed:

eGERD
NERD
PPI therapy

Pantoprazole
Erosive Gastroesophageal Reflux Disease
Non-Erosive Reflux Disease

Additional relevant MeSH terms:

Disease
Gastrointestinal Diseases
Pantoprazole
Nervous System Diseases
Gastrointestinal Agents
Sleep Disorders
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders

Deglutition Disorders
Signs and Symptoms
Pathologic Processes
Digestive System Diseases
Mental Disorders
Therapeutic Uses
Anti-Ulcer Agents
Neurologic Manifestations
Esophageal Diseases

ClinicalTrials.gov processed this record on February 08, 2010