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

Condition(s) targeted: Gastroesophageal Reflux

Intervention: Pantoprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: ALTANA Pharma

Official(s) and/or principal investigator(s):
Hartmut Heinze, MD, Study Chair, Affiliation: Altana Pharma AG, D-78467 Konstanz, Germany, info.clintrials@altanapharma.com

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.

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 design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Primary outcome: 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 outcome:

complete reflux disease remission rates after 4, 8, and 12 weeks

time to reach first complete remission

time to reach sustained complete remission

time to reach first symptom relief that is based on the pre-defined GERD symptoms threshold of the reflux questionnaire

average symptom load above pre-defined GERD symptoms threshold

relief rates from reflux disease related complaints after 4, 8 and 12 weeks

endoscopically confirmed healing rates after 4, 8, and 12 weeks

symptom relief rates after 4, 8 and 12 weeks

influence of the H. pylori status on the complete reflux disease remission rate

influence of the H. pylori status on the symptom relief rates

influence of the H. pylori status on the endoscopically confirmed healing rates.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

ALTANA Pharma, Cities in Austria, Austria

ALTANA Pharma, Cities in Germany, Germany

ALTANA Pharma, Cities in Hungary, Hungary

ALTANA Pharma, Cities in Poland, Poland

Starting date: May 2005
Last updated: May 16, 2007