Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)

GERD Clinical Trial

Official title:

COMPETITION: Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease (GERD) Symptom Changes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336219
• Other study ID #: BY1023/M3-343
• Status: Completed
• Phase: Phase 3
• First received: June 12, 2006
• Last updated: May 4, 2012
• Start date: August 2006
• Est. completion date: April 2007

Study information

• Verified date: October 2008
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: April 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

• Written informed consent

• Outpatients

• History of GERD-related symptoms for at least 6 months prior to study inclusion

• Endoscopically confirmed erosive GERD or non-erosive GERD

Main Exclusion Criteria:

• Acute peptic ulcer and/or ulcer complications

• PPIs during last 7 days prior to study start

• Systemic glucocorticoids or non-steroidal anti-inflammatory drugs including COX-2 inhibitors during the last 28 days prior to study start; except regular intake of acetylsalicylic acid up to a daily dose of 163 mg/day

• Intake of PPIs in combination with antibiotics for eradication of H. pylori

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Drug:
• Pantoprazole
Symptom Assessment after treatment with Pantoprozole 40 mg

Locations

Country	Name	City	State
Australia	Altana Pharma/Nycomed	Bondi Junction
Australia	Altana Pharma/Nycomed	Box Hill, Victoria
Australia	Altana Pharma/Nycomed	New South Wales
Australia	Altana Pharma/Nycomed	South Australia
Austria	Altana Pharma/Nycomed	Feldbach
Austria	Altana Pharma/Nycomed	Graz
Austria	Altana Pharma/Nycomed	Stockerau
Austria	Altana Pharma/Nycomed	Wien
Austria	Altana Pharma/Nycomed	Wiener Neustadt
Germany	Altana Pharma/Nycomed	Amberg
Germany	Altana Pharma/Nycomed	Aschersleben
Germany	Altana Pharma/Nycomed	Berlin
Germany	Altana Pharma/Nycomed	Berlin
Germany	Altana Pharma/Nycomed	Berlin
Germany	Altana Pharma/Nycomed	Freising
Germany	Altana Pharma/Nycomed	Germersheim
Germany	Altana Pharma/Nycomed	Grünstadt
Germany	Altana Pharma/Nycomed	Jülich
Germany	Altana Pharma/Nycomed	Köln
Germany	Altana Pharma/Nycomed	Köln
Germany	Altana Pharma/Nycomed	Köthen
Germany	Altana Pharma/Nycomed	Künzing
Germany	Altana Pharma/Nycomed	Landsberg
Germany	Altana Pharma/Nycomed	Langen
Germany	Altana Pharma/Nycomed	Leipzig
Germany	Altana Pharma/Nycomed	Ludwigshafen
Germany	Altana Pharma/Nycomed	Lüneburg
Germany	Altana Pharma/Nycomed	Mönchengladbach
Germany	Altana Pharma/Nycomed	München
Germany	Altana Pharma/Nycomed	Potsdam-Babelsberg
Germany	Altana Pharma/Nycomed	Reinfeld
Germany	Altana Pharma/Nycomed	Saarbrücken
Hungary	Altana Pharma/Nycomed	Budapest
Hungary	Altana Pharma/Nycomed	Györ
Hungary	Altana Pharma/Nycomed	Hatvan
Hungary	Altana Pharma/Nycomed	Kaposvár
Hungary	Altana Pharma/Nycomed	Kistarcsa
Hungary	Altana Pharma/Nycomed	Miskolc
Hungary	Altana Pharma/Nycomed	Szentes
Hungary	Altana Pharma/Nycomed	Vác

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Australia,  Austria,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom assessment as measured by ReQuest™ questionnaire and investigator.		28 days	No
Secondary	symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator		28 days	No
Secondary	endoscopic healing after 28 days		28 days	No
Secondary	health-related quality of life after 28 days		28 days	No
Secondary	safety.		28 days	Yes