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

NCT ID: NCT01601379

Last Updated: 2016-05-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7964 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-06-30

Brief 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.

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=2358&filename=CR016519_CSR.pdf

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

Other Identifiers

RABGRD4048

Identifier Type: OTHER

Identifier Source: secondary_id

CR016519

Identifier Type: -

Identifier Source: org_study_id