Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Symptoms of Non-Erosive Reflux or Erosive Gastroesophageal Reflux - Full Text View

Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Symptoms of Non-Erosive Reflux or Erosive Gastroesophageal Reflux (PANTHER)

This study is currently recruiting participants.

Verified by Nycomed, January 2009

Sponsored by:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00561730

Purpose

The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) in clinical practice. During the study, the patients will complete a short version of a patient-orientated, self-assessed reflux questionnaire (ReQuest™ in Practice). The study will provide further data on safety and tolerability of pantoprazole.

Condition	Intervention
Gastroesophageal Reflux	Drug: Pantoprazole

MedlinePlus related topics: GERD

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Pantoprazole 20 mg/40mg for Gastroesophageal Reflux Disease (GERD).

Further study details as provided by Nycomed:

Primary Outcome Measures:

To evaluate a short version of a patient-orientated, self-assessed reflux questionnaire in clinical practice (ReQuest™ in Practice) [ Time Frame: 7 days ]

Secondary Outcome Measures:

To survey epidemiological data for the prevalence of eGERD and NERD [ Time Frame: 7 days ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2500
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2008

Groups/Cohorts	Assigned Interventions
Panther	Drug: Pantoprazole This is an observational study. Therefore, the physician decides about dosage according to individual needs.

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:

eGERD (according to Los Angeles classification grade A-D)
NERD

Main exclusion criteria:

Hypersensitivity
Co-administration with Atazanavir
Pregnancy
Other 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: NCT00561730

Contacts

Contact: Nycomed Info

clinicaltrials@nycomed.com

Show 262 Study Locations

Sponsors and Collaborators

Nycomed

Investigators

Study Director:

Dr. Thomas D. Bethke, MD, MBA

Nycomed Deutschland GmbH, 78467 Konstanz, Germany

More Information

Study ID Numbers:	PAN 20/40 Panther 07/10
Study First Received:	November 12, 2007
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00561730
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Pantoprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009