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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT01499693
Eligibility Criteria:
Main inclusion criteria:
* Carlsson-Dent Questionnaire with score ≤ 4 (negative for GERD).
* Endoscopy: negative for GERD
* BMI between 18.5 and 30
Main exclusion criteria:
* Volunteers with any the following symptoms: dysphagia, digestive track bleeding, anorexia, anemia, involuntary weight loss.
* Women under breastfeeding period, pregnant or under pregnancy suspicion.
* Subjects with abnormal manometry (any motor esophageal disorder).
* Peptic ulcer history and/or ulcer complication.
* Volunteers under PPI treatment, H. pylori eradication treatment, H2 receptor antagonists, prokinetics or similar medication (current, during the last 30 days or during the trial).
* History of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAID) use, during the last 30 days.
* Abnormal laboratory parameters or vital signs, considered clinically relevant by the researcher.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01499693
Study Brief:
Protocol Section:
NCT01499693