Gastroesophageal Reflux DiseaseEpi-ERGENCT04094402
Epi-GERD Study: Epidemiological Evaluation in Patients With Gastro-Esophageal Reflux Disease (GERD)
An observational study of Gastroesophageal Reflux Disease, run by Scandinavia Pharma at 1 site in Colombia.
Trial summary
Cross-sectional epidemiological study in patients with diagnosis of GERD (Gastroesophageal Reflux Disease) and with current treatment or with a history of recent treatment with some PPI (Proton Pump Inhibitor), in order to evaluate the persistence and / or relapse of symptoms of GERD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- None. It is an observational study
- How many people
- 1,500 participants
- Where
- 1 siteColombia
- Study dates
- 4 Jun 2019to Jul 2024
- 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 ≥ 18 years, with previous diagnosis of Gastroesophageal Reflux Disease (GERD)
Who may be able to join
- Age ≥ 18 years
- Previous diagnosis of Gastroesophageal Reflux Disease (GERD)
- CURRENT treatment with a proton-pump inhibitor (PPI), OR NOT CURRENT treatment with some PPI but YES in the last year
Who cannot join
- Refusal to participate in the study by the patient.
- Patients who, in the judgment of the Investigator, do not understand or are not willing to adequately answer to the questions.
- Mental or psychiatric illness that, in the judgment of the investigator, does not allow adequate information to be obtained.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Scandinavia Pharma
Bogotá, 110111
Javier Castillo, Dr
About this study
Official title: Epi-GERD Study: Epidemiological Evaluation in Patients With Gastro-Esophageal Reflux
Cross-sectional epidemiological study in patients with diagnosis of GERD (Gastroesophageal Reflux Disease) and with current treatment or with a history of recent treatment with some PPI (Proton Pump Inhibitor), in order to evaluate the persistence and / or relapse of symptoms of GERD.
Read the detailed description
OBJECTIVE: To carry out an evaluation about the persistence and / or relapse of symptoms in Colombian patients with diagnosis of GERD.
MATERIALS AND METHODS: A multicentric cross-sectional epidemiological study will be carried out in Colombian patients with diagnosis of GERD and with current treatment or with a history of recent treatment with some PPI (Proton Pump Inhibitor). The persistence and / or relapse of symptoms will be evaluated as the main variable. The secondary variables to be evaluated include: Demographical analysis, treatment (s) used by patients, adverse events associated with the treatments, comorbidities and risk factors. The analysis will be carried out from two perspectives: A first descriptive approach and a second analytical approach, with a level of significance of 5%.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- None. It is an observational study
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None. It is an observational studyOther
None. It is an observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of GERD (Gastroesophageal Reflux Disease)
Proportion of patients with persistence and / or relapse of symptoms of GERD.
Measured: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
Secondary outcomes (3)
Demographic analysis
Characterization of patients
Measured: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
Kind of IBP taked by the patient and the way to consume it.
A descriptive analysis of the type of IBP types taken by patients and how to take them
Measured: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
Adverse Events related with the treatments
Evaluation of Adverse events associated with the treatment (s)
Measured: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start4 Jun 2019
- Primary completionDec 2023 (estimated)
- Study completionJul 2024 (estimated)
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scandinavia Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javier Castillo, Dr, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094402
- Sponsor's protocol ID
- Epi-ERGE
- Acronym
- Epi-ERGE
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epi-GERD Study: Epidemiological Evaluation in Patients With Gastro-Esophageal Reflux
- ClinicalTrials.gov ID
- NCT04094402
- Acronym / sponsor ID
- Epi-ERGE / Epi-ERGE
- Conditions
- Gastroesophageal Reflux Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Scandinavia PharmaIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 18 Sep 2019 (actual)
- 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.
Cross-sectional epidemiological study in patients with diagnosis of GERD (Gastroesophageal Reflux Disease) and with current treatment or with a history of recent treatment with some PPI (Proton Pump Inhibitor), in order to evaluate the persistence and / or relapse of symptoms of GERD.
Detailed description
OBJECTIVE: To carry out an evaluation about the persistence and / or relapse of symptoms in Colombian patients with diagnosis of GERD.
MATERIALS AND METHODS: A multicentric cross-sectional epidemiological study will be carried out in Colombian patients with diagnosis of GERD and with current treatment or with a history of recent treatment with some PPI (Proton Pump Inhibitor). The persistence and / or relapse of symptoms will be evaluated as the main variable. The secondary variables to be evaluated include: Demographical analysis, treatment (s) used by patients, adverse events associated with the treatments, comorbidities and risk factors. The analysis will be carried out from two perspectives: A first descriptive approach and a second analytical approach, with a level of significance of 5%.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 18 years, with previous diagnosis of Gastroesophageal Reflux Disease (GERD)
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Previous diagnosis of Gastroesophageal Reflux Disease (GERD)
- CURRENT treatment with a proton-pump inhibitor (PPI), OR NOT CURRENT treatment with some PPI but YES in the last year
Key exclusion criteria (3 listed)
- Refusal to participate in the study by the patient.
- Patients who, in the judgment of the Investigator, do not understand or are not willing to adequately answer to the questions.
- Mental or psychiatric illness that, in the judgment of the investigator, does not allow adequate information to be obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None. It is an observational studyNone. It is an observational study | Other | – |
Primary outcome
Symptoms of GERD (Gastroesophageal Reflux Disease)
Time frame: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
Proportion of patients with persistence and / or relapse of symptoms of GERD.
3 secondary outcomes
Demographic analysis
Time frame: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
Kind of IBP taked by the patient and the way to consume it.
Time frame: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
Adverse Events related with the treatments
Time frame: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Javier Castillo, Dr study director
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease, run by Scandinavia Pharma at 1 site in Colombia.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Castillo, Dr (+571-6461700, jcastill@scandinavia.com.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of GERD (Gastroesophageal Reflux Disease) (time frame: It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years). 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 23 Sep 2019.