Gastroesophageal Reflux DiseasePROFILENCT01601379
Observational Study (This Means That no Drug is Tested) in Patients Suffering of Gastroesophageal Reflux Disease.
An observational study of Gastroesophageal Reflux Disease and Gastro-oesophageal Reflux, run by Janssen-Cilag International NV.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease, Gastro-oesophageal Reflux, Gastro-Esophageal Reflux
- How many people
- 7,964 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
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.
Read the 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
- Keywords
- Observational, GERD, Gastroesophageal Reflux Disease, Gastro-oesophageal Reflux, Heartburn
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7,964 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601379
- Sponsor's protocol ID
- CR016519
- Other IDs
- RABGRD4048
- Acronym
- PROFILE
- Status last verified
- May 2016
- First submitted
- 22 Mar 2012
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01601379
- Acronym / sponsor ID
- PROFILE / CR016519
- Conditions
- Gastroesophageal Reflux Disease, Gastro-oesophageal Reflux, Gastro-Esophageal Reflux, Esophageal Reflux, GERD
- Keywords
- Observational, GERD, Gastroesophageal Reflux Disease, Gastro-oesophageal Reflux, Heartburn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,964 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Classification of adult patients suffering from typical GERD symptoms
Time frame: Day 1
The primary objective is to determine a classification of adult patients based on the presence or absence of 13 signs and symptoms characterizing GERD.
2 secondary outcomes
Association with weight related variables
Time frame: Day 1
Association with GERD related factors
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- 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 studyLink provided by the sponsor.
Related trials for Gastroesophageal Reflux Disease
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Gastro-oesophageal Reflux, run by Janssen-Cilag International NV.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification of adult patients suffering from typical GERD symptoms (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.