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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)

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ClinicalTrials.gov Identifier: NCT00829738
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : September 24, 2010
Last Update Posted : May 8, 2012
Sponsor:
Information provided by:
Nycomed

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

Study Design
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Study Type : Observational
Actual Enrollment : 4188 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pantoprazole 20/40 mg in Reflux-Associated Complaints With Focus on Gastrointestinal Symptoms
Study Start Date : January 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Groups and Cohorts
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Group/Cohort Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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 :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
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
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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


Locations
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Sponsors and Collaborators
Nycomed
Investigators
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Study Director: Thomas D. Bethke, MD, MBA Nycomed Deutschland GmbH, 78467 Konstanz, Germany
More Information
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Responsible Party: Medical Responsible, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00829738    
Other Study ID Numbers: P2-9999-011-DE
First Posted: January 27, 2009    Key Record Dates
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:
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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