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

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163306

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: Pantoprazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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

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:

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 Measures:

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.

Estimated Enrollment:	1200
Study Start Date:	May 2005

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163306

Show 79 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Study Chair:

Hartmut Heinze, MD

Altana Pharma AG, D-78467 Konstanz, Germany, info.clintrials@altanapharma.com

More Information

No publications provided

Study ID Numbers:	BY1023/M3-339
Study First Received:	September 12, 2005
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00163306 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ALTANA Pharma:

Gastroesophageal Reflux
Gastroesophageal Reflux Disease
Pantoprazole

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal Disorder

Gastrointestinal Diseases
Pantoprazole
Esophageal Diseases
Gastroesophageal Reflux

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 September 11, 2009