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:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00829738
First received: January 13, 2009
Last updated: May 4, 2012
Last verified: May 2012
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

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 gastroesophageal reflux disease (GERD)

Main exclusion criteria:

  • Criteria as defined in the Summary of Product Characteristics
  Contacts and Locations
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, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Medical Responsible, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00829738     History of Changes
Other Study ID Numbers: P2-9999-011-DE
Study First Received: January 13, 2009
Results First Received: September 1, 2010
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Digestive System Diseases
Signs and Symptoms
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014