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

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00561730
First received: November 12, 2007
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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).


Condition Intervention
Gastroesophageal Reflux Disease
Drug: Pantoprazole

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pantoprazole 20 mg/40 mg for the Treatment of Gastroesophageal Reflux Disease (GERD)

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad

  • Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: Severity from 0=None to 10=Extremely strong

  • Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: Severity from 0=None to 10=Extremely strong

  • Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: Severity from 0=None to 10=Extremely strong

  • Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: Severity from 0=None to 10=Extremely strong

  • Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Assessment on a scale: Severity from 0=None to 10=Extremely strong


Secondary Outcome Measures:
  • 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 20 mg/40 mg 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 20 mg/40 mg 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: 1995
Study Start Date: October 2007
Study Completion Date: December 2008
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 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)
  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: NCT00561730

  Show 259 Study Locations
Sponsors and Collaborators
Nycomed
Investigators
Study Director: Dr. Thomas D. Bethke, MD, MBA Nycomed Deutschland GmbH, 78467 Konstanz, Germany
  More Information

No publications provided

Responsible Party: Medical Director, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00561730     History of Changes
Other Study ID Numbers: PAN 20/40 Panther 07/10
Study First Received: November 12, 2007
Results First Received: August 23, 2010
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014