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

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.

Intervention(s) 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

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

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

Lead Investigator: Nycomed Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

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