Observational Study (This Means That no Drug is Tested) in Patients Suffering of Gastroesophageal Reflux Disease. (PROFILE)

Symptoms of Gastroesophageal Reflux Disease (GERD): Classification of Adult Subjects Suffering From Typical GERD Symptoms and Description of the Most Frequent Symptom Profiles and Characteristics - European Observational Study

The purpose of this observational study (this means that no drug is being tested in this study) is to obtain updated and detailed information about the Gastroesophageal Reflux Disease (GERD) specificities in European patients. The information about patients suffering from typical GERD symptoms will be collected in order to establish a classification of adult patients profile based on the characteristics of GERD symptoms. This study will only involve data collection about the disease. The treatment will not be affected by the study.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease; GERD; Gastro-oesophageal Reflux; Gastro-Esophageal Reflux; Esophageal Reflux

Detailed Description

Gastroesophageal reflux disease (GERD) is one of the most common disorders seen by primary care providers and gastroenterologists in the United States and Europe. GERD is more than just heartburn, which is only one of several complaints. Patients can also suffer from regurgitation, nausea, sore throat, cough, hiccups, chest pain, sleep disturbance, etc. Individuals with the typical GERD symptoms (heartburn and/or acid regurgitation) constitute a diverse group. The detailed characterization of the different symptoms and their associations, but also their link with clinical or epidemiologic factors (age, body mass index [BMI], history of GERD, comorbidities, etc.), would help the physician to better individualize patient profiles and to adapt GERD management, enabling a better therapeutic response. In many studies the relationship between obesity and GERD has been looked at. However, the results of these studies are sometimes contradictory. The connection between obesity and elevated risk of GERD symptoms has been reported, although study results were sometimes contradictory (that is some of the studies showed that patients who were overweight did develop GERD symptoms more often than patients who had a normal weight; other studies did not show such a relationship). The purpose of this study is to update the data concerning adult patients suffering from GERD in European countries, as well as to explore the association between BMI and GERD symptoms, by determining the relative risks in patients belonging to different categories of BMI.This observational study will enroll patients who present at least 1 typical symptom of GERD (e.g., heartburn and/or regurgitation (the return of gastric content from the stomach to the mouth or throat)) in the week before inclusion in this study. The aim is to collect information about the symptom characteristics during one visit. During this visit, general information (age, weight, height,BMI), information about the medical history (including smoking and drinking habits, and drug use), information about any other diseases and lifestyle habits and detailed information about GERD (such as when it was fist diagnosed, how long the symptoms are present and when they occur, how they are treated) will be collected. A physical examination will be performed, consisting of a weight and height measurement, calculation of the body mass index (BMI), and a measurement of the waist. During the visit, the next steps for the GERD therapy (including changes in life style habits) will be discussed and this information will also be collected.

• Study Type: Observational
• Enrollment (Actual): 7964

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients suffering from GERD and presenting at least 1 of the typical GERD symptoms (i.e., heartburn and/or regurgitation), at least once a week, in the week prior to the first (and only) study visit are candidates for documentation in this study.

Description

Inclusion Criteria:

• Patient has an established diagnosis of GERD according to the investigator, or an occurrence of at least 1 typical GERD symptom (i.e., heartburn or regurgitation) at least once a week during the last 3 months.
• Patient has presented at least 1 typical GERD symptom (i.e., heartburn or regurgitation) in the week preceding the study visit.

Exclusion Criteria:

• Exclusively atypical digestive or non-digestive symptoms (e.g., epigastralgia, respiratory disturbances, thoracic manifestations, etc.)
• Current or recent (less than 1 year) history of gastric or duodenal ulcer
• History of surgery of the upper digestive tract
• Tumor of the superior digestive tract or ENT system;
• Pregnant or breastfeeding woman

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Classification of adult patients suffering from typical GERD symptoms	The primary objective is to determine a classification of adult patients based on the presence or absence of 13 signs and symptoms characterizing GERD.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association with weight related variables	The association will be explored between weight related variables (e.g., BMI classes, waist circumference) and the found classification of patients.	Day 1
Association with GERD related factors	The association will be explored between other GERD related factors (e.g., history of GERD, treatment) and the found classification of patients.	Day 1

Collaborators and Investigators

• Sponsor: Janssen-Cilag International NV

Publications and helpful links

Helpful Links

• Symptoms of gastroesophageal reflux disease (GERD): Classification of adult subjects suffering from typical GERD symptoms and description of the most frequent symptom profiles and characteristics - European observational study

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: May 17, 2012
• First Posted (Estimate): May 18, 2012

Study Record Updates

• Last Update Posted (Estimate): May 27, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: GERD; Observational; Gastroesophageal Reflux Disease; Heartburn; Gastro-oesophageal Reflux
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic
• Other Study ID Numbers: CR016519; RABGRD4048 (Other Identifier: Janssen CTMS ID)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No