Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)

Gastroesophageal Reflux Clinical Trial

Official title:

Complete Remission: Evaluation of the Complete Remission Rates in Patients With Symptomatic Non-erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (GERD) Treated With Pantoprazole 40 Milligram o.d. Over 4 or 8 or 12 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163306
• Other study ID #: BY1023/M3-339
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 4, 2012
• Start date: May 2005

Study information

• Verified date: May 2007
• 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

Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting symptoms related to gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of GERD in a large proportion of patients.

When refluxed stomach acidic content touches the lining of the esophagus, it causes a burning sensation in the chest or throat. This sensation is often referred to as heartburn. Some patients have symptoms of GERD without visible destruction of the tissue surface (no visible changes by endoscopic examination).

The aim of the study is to evaluate the effect of pantoprazole on the complete remission of GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in the morning. Endoscopy will be performed at the start of the study, and then as required after 4, 8, or 12 weeks. The study will provide further data on safety and tolerability of pantoprazole.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

• Outpatients

• Reflux disease-related symptoms for at least 12 weeks, which need not be consecutive, in the previous 12 months or endoscopically confirmed reflux esophagitis grade A to D, according to LA-classification

Main Exclusion Criteria:

• Regular intake of systemic glucocorticosteroids, NSAIDs including COX-2 inhibitors on >3 consecutive days per week within the previous 28 days; exception: regular intake of acetylsalicylic acid up to a daily dose of 150 mg/day

• Intake of PPIs (proton pump inhibitor) during the last 10 days, of histamine 2-receptor antagonists or prokinetics during the last 5 days, intake of sucralfate during the last 2 days before the start of the study

• Intake of PPIs in combination with antibiotics for eradication of H. pylori during the last 28 days prior to study start

• Eradication of H. pylori during the last 28 days prior to study start

• Acute peptic ulcer and/or ulcer complications

Study Design

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Pantoprazole

Locations

Country	Name	City	State
Austria	Altana Pharma/Nycomed	Deutschlandsberg
Austria	Altana Pharma/Nycomed	Feldbach
Austria	Altana Pharma/Nycomed	Graz
Austria	Altana Pharma/Nycomed	Graz
Austria	Altana Pharma/Nycomed	Krems a. d. Donau
Austria	Altana Pharma/Nycomed	Lilienfeld
Austria	Altana Pharma/Nycomed	Stockerau
Austria	Altana Pharma/Nycomed	Wien
Austria	Altana Pharma/Nycomed	Wien
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	Bad Bramstedt
Germany	Altana Pharma/Nycomed	Bad Schwalbach
Germany	Altana Pharma/Nycomed	Beckum
Germany	Altana Pharma/Nycomed	Berlin
Germany	Altana Pharma/Nycomed	Berlin
Germany	Altana Pharma/Nycomed	Berlin
Germany	Altana Pharma/Nycomed	Flensburg
Germany	Altana Pharma/Nycomed	Freiburg
Germany	Altana Pharma/Nycomed	Freising
Germany	Altana Pharma/Nycomed	Germersheim
Germany	Altana Pharma/Nycomed	Hamburg
Germany	Altana Pharma/Nycomed	Haßfurt
Germany	Altana Pharma/Nycomed	Herzogenrath
Germany	Altana Pharma/Nycomed	Jülich
Germany	Altana Pharma/Nycomed	Kirchheimbolanden
Germany	Altana Pharma/Nycomed	Landsberg
Germany	Altana Pharma/Nycomed	Langen
Germany	Altana Pharma/Nycomed	Leipzig
Germany	Altana Pharma/Nycomed	Lübeck
Germany	Altana Pharma/Nycomed	Ludwigsburg
Germany	Altana Pharma/Nycomed	Ludwigshafen
Germany	Altana Pharma/Nycomed	Lütjenburg
Germany	Altana Pharma/Nycomed	Magdeburg
Germany	Altana Pharma/Nycomed	Magdeburg
Germany	Altana Pharma/Nycomed	Mönchengladbach
Germany	Altana Pharma/Nycomed	München
Germany	Altana Pharma/Nycomed	München
Germany	Altana Pharma/Nycomed	Nieder-Olm
Germany	Altana Pharma/Nycomed	Oelde
Germany	Altana Pharma/Nycomed	Potsdam-Babelsberg
Germany	Altana Pharma/Nycomed	Reinfeld
Germany	Altana Pharma/Nycomed	Rottweil
Germany	Altana Pharma/Nycomed	Saarbrücken
Germany	Altana Pharma/Nycomed	Schweinfurt
Germany	Altana Pharma/Nycomed	Stuttgart
Germany	Altana Pharma/Nycomed	Tessin
Germany	Altana Pharma/Nycomed	Wiesbaden
Germany	Altana Pharma/Nycomed	Wolfsburg
Germany	Altana Pharma/Nycomed	Wolmirstedt
Hungary	Altana Pharma/Nycomed	Budapest
Hungary	Altana Pharma/Nycomed	Budapest
Hungary	Altana Pharma/Nycomed	Budapest
Hungary	Altana Pharma/Nycomed	Budapest
Hungary	Altana Pharma/Nycomed	Györ
Hungary	Altana Pharma/Nycomed	Gyula
Hungary	Altana Pharma/Nycomed	Hatvan
Hungary	Altana Pharma/Nycomed	Kaposvár
Hungary	Altana Pharma/Nycomed	Miskolc
Hungary	Altana Pharma/Nycomed	Pécs
Hungary	Altana Pharma/Nycomed	Szeged
Hungary	Altana Pharma/Nycomed	Szekesfehervar
Hungary	Altana Pharma/Nycomed	Szekszárd
Hungary	Altana Pharma/Nycomed	Szentes
Hungary	Altana Pharma/Nycomed	Szombathely
Hungary	Altana Pharma/Nycomed	Tatabanya
Hungary	Altana Pharma/Nycomed	Vác
Poland	Altana Pharma/Nycomed	Bydgoszcz
Poland	Altana Pharma/Nycomed	Drezdenko
Poland	Altana Pharma/Nycomed	Kielce
Poland	Altana Pharma/Nycomed	Kraków
Poland	Altana Pharma/Nycomed	Rzeszow
Poland	Altana Pharma/Nycomed	Rzeszow
Poland	Altana Pharma/Nycomed	Slupsk
Poland	Altana Pharma/Nycomed	Sopot
Poland	Altana Pharma/Nycomed	Torun
Poland	Altana Pharma/Nycomed	Tychy

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Austria,  Germany,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete reflux disease remission rate after 8 weeks of treatment defined as symptom relief assessed by reflux questionnaire (ReQuest Trademark) and endoscopically confirmed healing.
Secondary	complete reflux disease remission rates after 4, 8, and 12 weeks
Secondary	time to reach first complete remission
Secondary	time to reach sustained complete remission
Secondary	time to reach first symptom relief that is based on the pre-defined GERD symptoms threshold of the reflux questionnaire
Secondary	average symptom load above pre-defined GERD symptoms threshold
Secondary	relief rates from reflux disease related complaints after 4, 8 and 12 weeks
Secondary	endoscopically confirmed healing rates after 4, 8, and 12 weeks
Secondary	symptom relief rates after 4, 8 and 12 weeks
Secondary	influence of the H. pylori status on the complete reflux disease remission rate
Secondary	influence of the H. pylori status on the symptom relief rates
Secondary	influence of the H. pylori status on the endoscopically confirmed healing rates.