Epi-GERD Study: Epidemiological Evaluation in Patients Wi... | NCT04094402

Studies
Epi-GERD Study: Epidemiological Evaluation in Patients With Gastro-Esophageal Reflux Disease (GERD)

NCT04094402

Sponsor

Scandinavia Pharma

Status

Unknown status

Last Update Posted

Sep 23, 2019Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Gastroesophageal Reflux Disease

Interventions

None. It is an observational study

Countries

Colombia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 4, 2019Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Jul 2024Estimated

First Submitted Date

Sep 16, 2019

First Submission Date that Met QC Criteria

Sep 17, 2019

First Posted Date

Sep 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2019

Last Update Posted Date

Sep 23, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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%.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
None. It is an observational study	Other	None. It is an observational study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptoms of GERD (Gastroesophageal Reflux Disease)	Proportion of patients with persistence and / or relapse of symptoms of GERD.	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

Measure	Description	Time Frame
Demographic analysis	Characterization of patients	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients ≥ 18 years, with previous diagnosis of Gastroesophageal Reflux Disease (GERD)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Javier Castillo, Dr	Contact	+571-6461700		jcastill@scandinavia.com.co
Ferrari Claudio, Dr	Contact	+571-6461700		cferrari@scandinavia.com.co

Overall Officials

Name	Affiliation	Role
Javier Castillo, Dr	Medical Director	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scandinavia Pharma	Recruiting	Bogotá		110111	Colombia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided