The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) with regard to symptomatic sleep disorders. The study will provide further data on safety and tolerability of pantoprazole...
Date First Received: November 12, 2007
Last Updated: July 14, 2008
Verified by: Nycomed, July 2008
Clinical Trial Phase: N/A | Start Date: November 2007
Overall Status: Recruiting
Estimated Enrollment: 10000
Brief Summary
Official Title: “Pantoprazole for the Treatment of GERD Associated Symptoms Focusing on Sleep Disorders.”
Condition Keyword(s):
Intervention(s):
The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) with regard to symptomatic sleep disorders. The study will provide further data on safety and tolerability of pantoprazole.
Study Type: Observational
Study Design: Case-Only, Prospective
Intervention(s) in this Clinical Trial
- Drug: Pantoprazole
- This is an observational study. Therefore, the physician decides about dosage according to individual needs.
Arms, Groups and Cohorts in this Clinical Trial
- : Puls
Outcome Measures for this Clinical Trial
Primary Measures
- Treatment success of reflux-associated symptomatic sleep disorders
- Time Frame: after 7 to 14 days
- Time Frame: after 7 to 14 days
Secondary Measures
- GERD-associated symptoms such as heartburn, feeling of fullness, belching, and upper abdominal complaints
- Time Frame: before and after treatment
- Time Frame: before and after treatment
Criteria for Participation in this Clinical Trial
Main inclusion criteria:
- eGERD (according to Los Angeles classification grade A-D)
- NERD
Main exclusion criteria:
- Hypersensitivity
- Co-administration with Atazanavir
- Pregnancy
- Other criteria as defined in the Summary of Product Characteristics (Fachinformation
- Chapter 4.3)
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Nycomed
Overall Clinical Trial Officials and Contacts
Dr. Thomas D. Bethke, MD, MBA Study Director Nycomed Deutschland GmbH, 78467 Konstanz, Germany
Overall Contact: Nycomed Info clinicaltrials@nycomed.com
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00562094
Study ID Number: PAN 20/40 PULS 07/10
ClinicalTrials.gov Identifier: NCT00562094
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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