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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT00587392
Eligibility Criteria:
Inclusion Criteria (required prior to original treatment):
* History of heartburn or regurgitation for at least 6-months requiring maintenance daily anti-secretory therapy;
* esophageal manometry study demonstrating peristaltic amplitude \>35mmHg and LES resting pressure \>/=5mmHg;
* Increased esophageal acid exposure demonstrated through a 24-hour pH study.
Exclusion Criteria (required prior to original treatment):
* Erosive esophagitis (Savary-Miller grade III or IV);
* Barrett's esophagus;
* Esophageal stricture;
* Hiatal hernia \>2cm;
* Persistent dysphagia, weight loss, esophageal bleeding, vomiting or gas-bloat
* Esophageal or gastric varices;
* Use of anticoagulants other than for cardiac prophylaxis
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00587392
Study Brief:
Protocol Section:
NCT00587392