Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Symptoms of Non-Erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (eGERD)

Official Title: “Pantoprazole 20 mg/40 mg for the Treatment of Gastroesophageal Reflux Disease (GERD)”

The aim of the study was to evaluate the effect of 7 days treatment with Pantoprazole 40 mg and 20 mg on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) in clinical practice. During the study, the patients had to complete a short version of a patient-orientated, self-assessed reflux questionnaire (ReQuest™ in Practice).

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

Primary Measures

• Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)
  • Time Frame: 7 days
    Safety Issue?: No
• Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
  • Time Frame: 7 days
    Safety Issue?: No
• Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
  • Time Frame: 7 days
    Safety Issue?: No
• Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)
  • Time Frame: 7 days
    Safety Issue?: No
• Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)
  • Time Frame: 7 days
    Safety Issue?: No
• Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)
  • Time Frame: 7 days
    Safety Issue?: No

Secondary Measures

• 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 20 mg/40 mg at Final Visit
  • Time Frame: 7 days
    Safety Issue?: No
• Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit
  • Time Frame: 7 days
    Safety Issue?: Yes

Main inclusion criteria:

• Outpatients with erosive gastro-esophageal reflux disease (eGERD according to Los
• Angeles classification grade A-D) or non-erosive reflux disease (NERD)

Main exclusion criteria:

• Criteria as defined in the 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

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/NCT00561730

Study ID Number: PAN 20/40 Panther 07/10

ClinicalTrials.gov Identifier: NCT00561730

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