Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders
Information source: Nycomed
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep Disorders; Non-Erosive Reflux Disease; Gastroesophageal Reflux Disease
Intervention: Pantoprazole (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Nycomed Official(s) and/or principal investigator(s):
Thomas Bethke, MD, MBA, Study Director, Affiliation: Nycomed Deutschland GmbH, 78467 Konstanz, Germany
Overall contact:
Nycomed Info, Email: info@nycomed.com
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.
Clinical Details
Official title: Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders.
Study design: Case-Only, Prospective
Primary outcome: Investigation of GERD-associated sleep disorders and how they are influenced by PPI therapyPrevalence and intensity will be documented by a standardized questionnaire
Secondary outcome: Prevalence of eGERD and NERD (ratio)
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Nycomed Info, Email: info@nycomed.com
Nycomed Deutschland GmbH, Hamburg 20123, Germany; Recruiting
Additional Information
Starting date: January 2009
Ending date: June 2009
Last updated: January 26, 2009
|
