|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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. |
| 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 |
Outpatients
Main inclusion criteria:
Main exclusion criteria:
Contacts and Locations
Show 201 Study Locations| Study Director: | Thomas Bethke, MD, MBA | Nycomed Deutschland GmbH, 78467 Konstanz, Germany |
More Information
| 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 |
|
eGERD NERD PPI therapy |
Pantoprazole Erosive Gastroesophageal Reflux Disease Non-Erosive Reflux Disease |
|
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 |