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Efficacy of Pantoprazole 20/40 mg Once Daily (od) in Patients Older Than 12 Years Who Have Gastrointestinal Symptoms of Reflux Disease (PARADE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829738
First Posted: January 27, 2009
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
  Purpose
The aim of this study was to evaluate the effect of 14 days treatment with Pantoprazole 40 mg and 20 mg on gastroesophageal reflux disease (GERD) related symptoms in a large patient population.

Condition Intervention
Gastroesophageal Reflux Disease Drug: Pantoprazole

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pantoprazole 20/40 mg in Reflux-Associated Complaints With Focus on Gastrointestinal Symptoms

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn [ Time Frame: 14 days ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  • Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation [ Time Frame: 14 days ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  • Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing [ Time Frame: 14 days ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  • Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms [ Time Frame: 14 days ]
    Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory


Secondary Outcome Measures:
  • Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain [ Time Frame: 14 days ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  • Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness [ Time Frame: 14 days ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  • Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea [ Time Frame: 14 days ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  • Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms [ Time Frame: 14 days ]
    Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

  • Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain [ Time Frame: 14 days ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  • Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea [ Time Frame: 14 days ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  • Irritable Bowel Syndrome: Assessment of the Severity of Constipation [ Time Frame: 14 days ]
    Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

  • Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome [ Time Frame: 14 days ]
    Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

  • Assessment of the Tolerability of Pantoprazole at Final Visit [ Time Frame: 14 days ]
    Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory


Enrollment: 4188
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
All patients enrolled
Drug: Pantoprazole
This was an observational study. Therefore, the physician decided about dosage according to individual needs (20 or 40 mg pantoprazole).

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 gastroesophageal reflux disease (GERD)

Main exclusion criteria:

  • Criteria as defined in the Summary of Product Characteristics
  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): NCT00829738


  Show 717 Study Locations
Sponsors and Collaborators
Nycomed
Investigators
Study Director: Thomas D. Bethke, MD, MBA Nycomed Deutschland GmbH, 78467 Konstanz, Germany
  More Information

Responsible Party: Medical Responsible, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00829738     History of Changes
Other Study ID Numbers: P2-9999-011-DE
First Submitted: January 13, 2009
First Posted: January 27, 2009
Results First Submitted: September 1, 2010
Results First Posted: September 24, 2010
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by Nycomed:
PPI therapy
pantoprazole
GERD (Erosive Gastroesophageal 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