Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341) - Full Text View

Sponsor:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00312806

Purpose

The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease (GERD)	Drug: Pantoprazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Real Life: Treatment Response in Patients With Symptoms Due to Gastroesophageal Reflux Disease Either With or Without Esophagitis Treated With Pantoprazole Sodium 40 mg o.d. Over 8 Weeks

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 ALTANA Pharma:

Primary Outcome Measures:

Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™ [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™ [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
Investigator assessment [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
Safety and efficacy [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	2000
Study Start Date:	May 2006
Study Completion Date:	July 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Pantoprazole 40 mg o.d.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Written informed consent
Outpatients of at least 18 years (21 years in Argentina)
Patient considered to have GERD symptoms

Main Exclusion Criteria:

Acute peptic ulcer and/or ulcer complications
Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) during the last 28 days before study start (except regular intake of acetylsalicylic acid at a dose up to 163 mg/day)
Intake of proton pump inhibitors during the last 10 days before study start
Female patients of childbearing potential not using adequate means of birth control
Pregnant or breast-feeding females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312806

Show 186 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

Hans-Joachim Ulmer, MD

Medical practice, D-71640 Ludwigsburg, Germany

More Information

No publications provided

Responsible Party:	Nycomed ( Nycomed )
Study ID Numbers:	BY1023/M3-341
Study First Received:	April 10, 2006
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00312806 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ALTANA Pharma:

Gastroesophageal Reflux Disease
GERD
Pantoprazole
ReQuestTM

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 November 27, 2009