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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT07041060
Eligibility Criteria:
Inclusion Criteria:Participants were eligible for the study if they met the following criteria:
* Had a diagnosis of non-erosive reflux disease (NERD) with typical reflux symptoms persisting for at least three months and occurring at least three times per week in the month preceding the study screening visit.
* Were aged between 18 and 80 years.
* Had been on therapy with a proton pump inhibitor (PPI) at a standard dosage for at least six weeks (40 mg pantoprazole/esomeprazole, 30 mg lansoprazole, or 20 mg omeprazole/rabeprazole).
* Had a diagnosis of NERD confirmed by the absence of macroscopic lesions of the distal esophageal mucosa on endoscopy performed within six months before the screening visit and a positive score on a validated questionnaire (Reflux Disease Questionnaire, RDQ Score ≥ 8).
Exclusion Criteria:Patients were excluded if they had any of the following conditions:
* Erosive esophagitis or Barrett's esophagus.
* Gastric or duodenal ulcer.
* History of major gastric or gastrointestinal surgery.
* Atopy or food intolerances.
* Thyroid disease.
* Diabetes or metabolic syndrome.
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07041060
Study Brief:
Protocol Section:
NCT07041060