Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT04255693
Eligibility Criteria:
Inclusion Criteria:
* willingness to participate (based on the signed informed consent form);
* presence of gastroesophageal reflux disease, based on the following: a) typical symptoms, like heartburn and/or regurgitation (for primary selection, symptoms should be present at least weekly, be actual for at least 3 months prior to the enrolment, and the patient should report the history of symptoms which lasts for at least 6 months); b) previous response to the intake of proton pump inhibitors; c) data of 24-hours oesophageal pH-impedance monitoring with detected pathological gastroesophageal reflux according to the Lyon consensus definitions;
Exclusion Criteria:
* pregnant or breast-feeding females;
* abdominal or chest surgery (except appendectomy or cholecystectomy in case they are not followed by adhesive disease of the abdominal organs);
* constant use of non-steroidal anti-inflammatory agents (NSAIDs), sporadic use of NSAIDs will be allowed in case the course of treatment was discontinued at least 2 weeks prior to the enrolment, in case that constant use of NSAIDs happen to be necessary after the enrolment, the patients may continue in the study but doses, frequency and duration of treatment should be carefully documented;
* history or current evidence of cancer of any aetiology and location besides skin cancer in situ successfully treated before the enrolment;
* severe patient's conditions which may lead to misinterpretation of data, or in case of patient's enrolment may put him at risk of exacerbation of co-morbid conditions, or in cases when on discretion of the investigator patient's condition would not allow him to complete the course of the observation. These conditions include, but not limited to: heart failure (class III-IV by NYHA), uncontrolled hypertension, severe neurological disorders, decompensated liver cirrhosis (Child-Pugh B or C), severe depression or other psychological disorders;
* the patient may stop his participation in the study at any time by informing the site personal about his/her decision to withdraw the consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04255693
Study Brief:
Protocol Section:
NCT04255693