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

Verified by: Nycomed, August 2010
First Received: January 13, 2009 | Last Updated: August 20, 2010 | Phase: N/A | Start Date: January 2009
Overall Status: Completed | Estimated Enrollment: 1045
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The aim of the study was 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 were evaluated by a standardized questionnaire. The study was expected to provide further data on safety and tolerability of pantoprazole...

Brief Summary

Official Title: “Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders”

The aim of the study was 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 were evaluated by a standardized questionnaire. The study was expected to provide further data on safety and tolerability of pantoprazole.

  • Study Type: Observational
  • Study Design: Observational Model: Case-Only, Time Perspective: Prospective
  • Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

  • Drug: Pantoprazole
    • Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).

Arms, Groups and Cohorts in this Clinical Trial

  • : Pantoprazole
    • All patients enrolled

Outcome Measures for this Clinical Trial

Primary Measures

  • Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
    • Time Frame: 7 days
      Safety Issue?: No
  • Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
    • Time Frame: 7 days
      Safety Issue?: No
  • Physician's Assessment of Sleep Disturbances
    • Time Frame: 7 days
      Safety Issue?: No

Secondary Measures

  • Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)
    • Time Frame: 7 days
      Safety Issue?: No
  • Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)
    • Time Frame: 7 days
      Safety Issue?: No
  • Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)
    • Time Frame: 7 days
      Safety Issue?: No
  • Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)
    • Time Frame: 7 days
      Safety Issue?: No
  • Patient's Assessment of Nausea for the Last 24 Hours (Diaries)
    • Time Frame: 7 days
      Safety Issue?: No
  • Physician's Assessment of Heartburn
    • Time Frame: 7 days
      Safety Issue?: No
  • Physician's Assessment of Acid Eructation
    • Time Frame: 7 days
      Safety Issue?: No
  • Physician's Assessment of Painful Swallowing
    • Time Frame: 7 days
      Safety Issue?: No
  • Assessment of the Efficacy of Pantoprazole at Final Visit
    • Time Frame: 7 days
      Safety Issue?: No
  • Assessment of the Tolerability of Pantoprazole at Final Visit
    • Time Frame: 7 days
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Main inclusion criteria:

  • Outpatients with erosive gastro-esophageal reflux disease (eGERD) or non-erosive reflux disease (NERD)

Main exclusion criteria:

  • Criteria as defined in the respective Summary of Product Characteristics (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 Investigator Information

Lead Investigator: Nycomed Industry

Overall Clinical Trial Officials and Contacts

Thomas Bethke, MD, MBA Study Director Nycomed Deutschland GmbH, 78467 Konstanz, Germany  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00830115

Study ID Number: P2-9999-010-DE

ClinicalTrials.gov Identifier: NCT00830115

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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