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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:
ClinicalTrials.gov Identifier:
NCT00561730
First Posted: November 21, 2007
Last Update Posted: May 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nycomed
November 12, 2007
November 21, 2007
August 23, 2010
September 16, 2010
May 8, 2012
October 2007
Not Provided
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
To evaluate a short version of a patient-orientated, self-assessed reflux questionnaire in clinical practice (ReQuest™ in Practice) [ Time Frame: 7 days ]
Complete list of historical versions of study NCT00561730 on ClinicalTrials.gov Archive Site
  • Physician's Assessment of Heartburn [ Time Frame: 7 days ]
    Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
  • Physician's Assessment of Acid Eructation [ Time Frame: 7 days ]
    Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
  • Physician's Assessment of Painful Swallowing [ Time Frame: 7 days ]
    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 ]
    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 ]
    Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
To survey epidemiological data for the prevalence of eGERD and NERD [ Time Frame: 7 days ]
Not Provided
Not Provided
 
Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Symptoms of Non-Erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (eGERD)
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).
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Outpatients
Gastroesophageal Reflux Disease
Drug: Pantoprazole
Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).
Pantoprazole
All patients enrolled
Intervention: Drug: Pantoprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1995
December 2008
Not Provided

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)
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00561730
PAN 20/40 Panther 07/10
No
Not Provided
Not Provided
Medical Director, Nycomed Deutschland GmbH
Nycomed
Not Provided
Study Director: Dr. Thomas D. Bethke, MD, MBA Nycomed Deutschland GmbH, 78467 Konstanz, Germany
Nycomed
May 2012