Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS)

Brief Summary

Official Title: “Pantoprazole for the Treatment of GERD Associated Symptoms Focusing on Sleep Disorders.”

The aim of the study was to evaluate the effect of Pantoprazole 20 mg/40 mg for 14 days on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) with special focus on the reduction of symptomatic sleep disorders.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: April 2009

Interventions Used in this Clinical Trial

  • Drug: Pantoprazole
    • This was an observational study. Therefore, the physician decided about dosage according to individual needs.

Arms, Groups and Cohorts in this Clinical Trial

  • Pantoprazole

Outcome Measures for this Clinical Trial

Primary Measures

  • Assessment of the Severity of Sleep Disturbances
    • Time Frame: first and last visit (after a median of 18 days)
      Safety Issue?: No
  • Assessment of Change of Quality of Sleep During Therapy With Pantoprazole
    • Time Frame: last visit (after a median of 18 days)
      Safety Issue?: No

Secondary Measures

  • Assessment of the Severity of Heartburn
    • Time Frame: first and last visit (after a median of 18 days)
      Safety Issue?: No
  • Assessment of the Severity of Eructation/Acid Eructation
    • Time Frame: first and last visit (after a median of 18 days)
      Safety Issue?: No
  • Assessment of the Severity of Epigastric Complaints/Epigastric Pain
    • Time Frame: first and last visit (after a median of 18 days)
      Safety Issue?: No
  • Assessment of the Severity of Sensation of Fullness/Abdominal Distension
    • Time Frame: first and last visit (after a median of 18 days)
      Safety Issue?: No
  • Assessment of the Efficacy of Pantoprazole at Final Visit
    • Time Frame: last visit (after a median of 18 days)
      Safety Issue?: No
  • Assessment of the Tolerability of Pantoprazole at Final Visit
    • Time Frame: last visit (after a median of 18 days)
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Main inclusion criteria:

  • GERD
  • NERD

Main exclusion criteria:

  • Criteria as defined in the Summary of Product Characteristics

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 Sponsor
    • Nycomed
  • Provider of Information About this Clinical Study
    • Medical Responsible, Nycomed Deutschland GmbH
  • Overall Official(s)
    • Dr. Thomas D. Bethke, MD, MBA, Study Director, Nycomed Deutschland GmbH, 78467 Konstanz, Germany

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00562094