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

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00830115
First received: January 13, 2009
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Sleep Disorders
Non-Erosive Reflux Disease
Gastroesophageal Reflux Disease
Drug: Pantoprazole

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts

  • Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

  • Physician's Assessment of Sleep Disturbances [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe


Secondary Outcome Measures:
  • Patient's Assessment of General Well-being for the Last 24 Hours (Diaries) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad

  • Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

  • Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

  • Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

  • Patient's Assessment of Nausea for the Last 24 Hours (Diaries) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

  • Physician's Assessment of Heartburn [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

  • Physician's Assessment of Acid Eructation [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

  • Physician's Assessment of Painful Swallowing [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

  • Assessment of the Efficacy of Pantoprazole at Final Visit [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

  • Assessment of the Tolerability of Pantoprazole at Final Visit [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory


Enrollment: 1045
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pantoprazole
All patients enrolled
Drug: Pantoprazole
Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830115

  Show 201 Study Locations
Sponsors and Collaborators
Nycomed
Investigators
Study Director: Thomas Bethke, MD, MBA Nycomed Deutschland GmbH, 78467 Konstanz, Germany
  More Information

No publications provided

Responsible Party: Medical Director, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00830115     History of Changes
Other Study ID Numbers: P2-9999-010-DE
Study First Received: January 13, 2009
Results First Received: July 20, 2010
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed:
PPI therapy
Pantoprazole
eGERD (Erosive Gastroesophageal Reflux Disease)
NERD (Non-Erosive Reflux Disease)

Additional relevant MeSH terms:
Gastroesophageal Reflux
Sleep Disorders
Parasomnias
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014