Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Gastrointestinal Symptoms of Reflux Disease - Full Text View

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:

MedlinePlus related topics: GERD

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

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

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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