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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: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00561730
First received: November 12, 2007
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
  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:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by Nycomed: A Takeda Company:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561730

  Show 259 Study Locations
Sponsors and Collaborators
Nycomed: A Takeda Company
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: A Takeda Company:
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013