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:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT00236392
Eligibility Criteria:
Inclusion Criteria:
* Minimum of 12 months history of heartburn as the predominant symptom with at least 2 symptomatic episodes
* Negative endoscopy (no erosive lesions according to the Modified Savary-Miller scale) within 7 days prior to acute treatment
* at least 3 days with moderate to very severe heartburn within one week prior to acute treatment
Exclusion Criteria:
* No known gastro-duodenal ulcer
* no infections, inflammations, or obstruction of the small or large intestine
* no history of gastrointestinal cancer, or prior surgery of the stomach or intestine
* no stomach or abdominal pain or discomfort as the predominant symptom or that requires treatment
* no history of erosive reflux causing inflammation of the esophagus
* no stricture of the esophagus, stomach, or any condition that causes difficulty in swallowing
* no history of non-erosive reflux disease (NERD) that is or was refractory to an adequate treatment course (1 month) with proton pump inhibitors
* no females who are pregnant or those lacking adequate contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00236392
Study Brief:
Protocol Section:
NCT00236392