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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT00182260
Eligibility Criteria:
Inclusion Criteria:
* Male and female GERD patients aged 18-70 years with GERD symptoms.
* Prior long-term treatment with PPI with minimum duration of 1 year with expected future duration of at least 2 more years.
* Controlled on 20-40mg/day maintenance PPI therapy prior to study, defined as GERD symptom score\<18 and score of 70 or more on 1-100 Global Rating Scale at screening (on medication).
* Increase in GERD symptom score\>=15 points at baseline (off omeprazole).
* GERD symptom score\>=18 at baseline (off omeprazole).
* Percent acid reflux in 24hr 4% at baseline (off omeprazole).
* Positive Bernstein test at baseline.
* Willingness to adhere to randomized treatment with availability for 3 years of follow-up.
* Ability to answer self and interviewer-administered questions in English.
* Signed informed consent.
Exclusion Criteria:
* Aperistaltic esophagus.
* Severe cardiac, respiratory, hematologic or other disease constituting an unacceptable surgical risk in the investigator's opinion.
* Previous gastric, esophageal or anti-reflux surgery.
* History of malignancy within the last year with the exception of basal cell carcinoma.
* Pregnancy or an intention to become pregnant in the following year.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00182260
Study Brief:
Protocol Section:
NCT00182260