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Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Gastrointestinal Symptoms of Reflux Disease (PARADE)
This study has been completed.
First Received: January 13, 2009   Last Updated: June 9, 2009   History of Changes
Sponsor: Nycomed
Information provided by: Nycomed
ClinicalTrials.gov Identifier: NCT00829738
  Purpose

The aim of this study is to quantify the characteristics of gastrointestinal symptoms and their alterations during treatment with pantoprazole in a large patient population with gastroesophageal reflux disease (GERD). The study will provide further data on safety and tolerability of pantoprazole.


Condition Intervention
Gastroesophageal Reflux Disease
Drug: Pantoprazole

Study Type: Observational
Study Design: Case-Only, 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:
  • Progression of reflux-associated gastrointestinal symptoms [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of treatment success according to different clinical subgroups (reflux symptoms, functional dyspepsia (FD-symptoms), Irritable Bowel Syndrome (IBS symptoms)) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 4500
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Parade Drug: Pantoprazole
This is an observational study. Therefore, the physician decides 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:

  • Patients with gastroesophageal reflux disease (GERD)

Main exclusion criteria:

  • Criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829738

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

No publications provided

Responsible Party: Nycomed Deutschland GmbH ( Medical Director )
Study ID Numbers: P2-9999-011-DE
Study First Received: January 13, 2009
Last Updated: June 9, 2009
ClinicalTrials.gov Identifier: NCT00829738     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed:
GERD
pantoprazole

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Gastrointestinal Diseases
Therapeutic Uses
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Esophageal Diseases
Gastroesophageal Reflux
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010