Clinical trial NCT00163306: Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Keywords: Gastroesophageal Reflux
Gastroesophageal Reflux Disease
Pantoprazole
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: complete reflux disease remission rates after 4, 8, and 12 weeks
measure: time to reach first complete remission
measure: time to reach sustained complete remission
measure: time to reach first symptom relief that is based on the pre-defined GERD symptoms threshold of the reflux questionnaire
measure: average symptom load above pre-defined GERD symptoms threshold
measure: relief rates from reflux disease related complaints after 4, 8 and 12 weeks
measure: endoscopically confirmed healing rates after 4, 8, and 12 weeks
measure: symptom relief rates after 4, 8 and 12 weeks
measure: influence of the H. pylori status on the complete reflux disease remission rate
measure: influence of the H. pylori status on the symptom relief rates
measure: influence of the H. pylori status on the endoscopically confirmed healing rates.
Other outcomes:
Locations:
city: Deutschlandsberg
country: Austria
facility: Altana Pharma/Nycomed
city: Feldbach
country: Austria
facility: Altana Pharma/Nycomed
city: Graz
country: Austria
facility: Altana Pharma/Nycomed
city: Graz
country: Austria
facility: Altana Pharma/Nycomed
city: Krems a. d. Donau
country: Austria
facility: Altana Pharma/Nycomed
city: Lilienfeld
country: Austria
facility: Altana Pharma/Nycomed
city: Stockerau
country: Austria
facility: Altana Pharma/Nycomed
city: Wiener Neustadt
country: Austria
facility: Altana Pharma/Nycomed
city: Wien
country: Austria
facility: Altana Pharma/Nycomed
city: Wien
country: Austria
facility: Altana Pharma/Nycomed
city: Wien
country: Austria
facility: Altana Pharma/Nycomed
city: Amberg
country: Germany
facility: Altana Pharma/Nycomed
city: Aschersleben
country: Germany
facility: Altana Pharma/Nycomed
city: Bad Bramstedt
country: Germany
facility: Altana Pharma/Nycomed
city: Bad Schwalbach
country: Germany
facility: Altana Pharma/Nycomed
city: Beckum
country: Germany
facility: Altana Pharma/Nycomed
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed
city: Flensburg
country: Germany
facility: Altana Pharma/Nycomed
city: Freiburg
country: Germany
facility: Altana Pharma/Nycomed
city: Freising
country: Germany
facility: Altana Pharma/Nycomed
city: Germersheim
country: Germany
facility: Altana Pharma/Nycomed
city: Hamburg
country: Germany
facility: Altana Pharma/Nycomed
city: Haßfurt
country: Germany
facility: Altana Pharma/Nycomed
city: Herzogenrath
country: Germany
facility: Altana Pharma/Nycomed
city: Jülich
country: Germany
facility: Altana Pharma/Nycomed
city: Kirchheimbolanden
country: Germany
facility: Altana Pharma/Nycomed
city: Landsberg
country: Germany
facility: Altana Pharma/Nycomed
city: Langen
country: Germany
facility: Altana Pharma/Nycomed
city: Leipzig
country: Germany
facility: Altana Pharma/Nycomed
city: Ludwigsburg
country: Germany
facility: Altana Pharma/Nycomed
city: Ludwigshafen
country: Germany
facility: Altana Pharma/Nycomed
city: Lübeck
country: Germany
facility: Altana Pharma/Nycomed
city: Lütjenburg
country: Germany
facility: Altana Pharma/Nycomed
city: Magdeburg
country: Germany
facility: Altana Pharma/Nycomed
city: Magdeburg
country: Germany
facility: Altana Pharma/Nycomed
city: Mönchengladbach
country: Germany
facility: Altana Pharma/Nycomed
city: München
country: Germany
facility: Altana Pharma/Nycomed
city: München
country: Germany
facility: Altana Pharma/Nycomed
city: Nieder-Olm
country: Germany
facility: Altana Pharma/Nycomed
city: Oelde
country: Germany
facility: Altana Pharma/Nycomed
city: Potsdam-Babelsberg
country: Germany
facility: Altana Pharma/Nycomed
city: Reinfeld
country: Germany
facility: Altana Pharma/Nycomed
city: Rottweil
country: Germany
facility: Altana Pharma/Nycomed
city: Saarbrücken
country: Germany
facility: Altana Pharma/Nycomed
city: Schweinfurt
country: Germany
facility: Altana Pharma/Nycomed
city: Stuttgart
country: Germany
facility: Altana Pharma/Nycomed
city: Tessin
country: Germany
facility: Altana Pharma/Nycomed
city: Wiesbaden
country: Germany
facility: Altana Pharma/Nycomed
city: Wolfsburg
country: Germany
facility: Altana Pharma/Nycomed
city: Wolmirstedt
country: Germany
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Gyula
country: Hungary
facility: Altana Pharma/Nycomed
city: Györ
country: Hungary
facility: Altana Pharma/Nycomed
city: Hatvan
country: Hungary
facility: Altana Pharma/Nycomed
city: Kaposvár
country: Hungary
facility: Altana Pharma/Nycomed
city: Miskolc
country: Hungary
facility: Altana Pharma/Nycomed
city: Pécs
country: Hungary
facility: Altana Pharma/Nycomed
city: Szeged
country: Hungary
facility: Altana Pharma/Nycomed
city: Szekesfehervar
country: Hungary
facility: Altana Pharma/Nycomed
city: Szekszárd
country: Hungary
facility: Altana Pharma/Nycomed
city: Szentes
country: Hungary
facility: Altana Pharma/Nycomed
city: Szombathely
country: Hungary
facility: Altana Pharma/Nycomed
city: Tatabanya
country: Hungary
facility: Altana Pharma/Nycomed
city: Vác
country: Hungary
facility: Altana Pharma/Nycomed
city: Bydgoszcz
country: Poland
facility: Altana Pharma/Nycomed
city: Drezdenko
country: Poland
facility: Altana Pharma/Nycomed
city: Kielce
country: Poland
facility: Altana Pharma/Nycomed
city: Kraków
country: Poland
facility: Altana Pharma/Nycomed
city: Rzeszow
country: Poland
facility: Altana Pharma/Nycomed
city: Rzeszow
country: Poland
facility: Altana Pharma/Nycomed
city: Slupsk
country: Poland
facility: Altana Pharma/Nycomed
city: Sopot
country: Poland
facility: Altana Pharma/Nycomed
city: Torun
country: Poland
facility: Altana Pharma/Nycomed
city: Tychy
country: Poland
facility: Altana Pharma/Nycomed
Study officials:
affiliation: Altana Pharma AG, D-78467 Konstanz, Germany, info.clintrials@altanapharma.com
name: Hartmut Heinze, MD
role: STUDY_CHAIR
References: