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

Gastroesophageal Reflux Disease Clinical Trial

— PROFILE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601379
• Other study ID #: CR016519
• Secondary ID: RABGRD4048
• Status: Completed
• Phase: Phase 4
• First received: March 22, 2012
• Last updated: May 25, 2016
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2016
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7964
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophageal Reflux
• Gastro-Esophageal Reflux
• Gastro-oesophageal Reflux
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• GERD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No

External 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