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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)

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ClinicalTrials.gov Identifier: NCT00561730
Recruitment Status : Completed
First Posted : November 21, 2007
Results First Posted : September 16, 2010
Last Update Posted : May 8, 2012
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Gastroesophageal Reflux Disease Drug: Pantoprazole

Study Design

Study Type : Observational
Actual Enrollment : 1995 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pantoprazole 20 mg/40 mg for the Treatment of Gastroesophageal Reflux Disease (GERD)
Study Start Date : October 2007
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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).


Outcome Measures

Primary Outcome Measures :
  1. Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice) [ Time Frame: 7 days ]
    Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad

  2. Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) [ Time Frame: 7 days ]
    Assessment on a scale: Severity from 0=None to 10=Extremely strong

  3. Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) [ Time Frame: 7 days ]
    Assessment on a scale: Severity from 0=None to 10=Extremely strong

  4. Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) [ Time Frame: 7 days ]
    Assessment on a scale: Severity from 0=None to 10=Extremely strong

  5. Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice) [ Time Frame: 7 days ]
    Assessment on a scale: Severity from 0=None to 10=Extremely strong

  6. Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice) [ Time Frame: 7 days ]
    Assessment on a scale: Severity from 0=None to 10=Extremely strong


Secondary Outcome Measures :
  1. Physician's Assessment of Heartburn [ Time Frame: 7 days ]
    Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

  2. Physician's Assessment of Acid Eructation [ Time Frame: 7 days ]
    Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

  3. Physician's Assessment of Painful Swallowing [ Time Frame: 7 days ]
    Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

  4. Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit [ Time Frame: 7 days ]
    Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

  5. Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit [ Time Frame: 7 days ]
    Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Medical Director, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00561730     History of Changes
Other Study ID Numbers: PAN 20/40 Panther 07/10
First Posted: November 21, 2007    Key Record Dates
Results First Posted: September 16, 2010
Last Update Posted: May 8, 2012
Last Verified: May 2012

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
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action