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
2 other identifiers
observational
7,964
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 22, 2012
CompletedFirst Posted
Study publicly available on registry
May 18, 2012
CompletedMay 27, 2016
May 1, 2016
1 year
March 22, 2012
May 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Association with weight related variables
Day 1
Association with GERD related factors
Day 1
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2012
First Posted
May 18, 2012
Study Start
June 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
May 27, 2016
Record last verified: 2016-05