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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT00251732
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Ages 18 to 75
* At least two episodes of heartburn per week while on PPI once daily
* Able to communicate with the investigator and comply with the requirements of the study
* Subjects who give written informed consent after being given a full description of the study.
Exclusion Criteria:
* Known allergy or intolerance to TCA
* Use of antidepressant or a diagnosis of depression
* History of serious arrhythmia or use of anti-arrhythmics
* History of seizures
* Subjects with significant co-morbidity, e.g., cardiovascular, respiratory, urogenital, renal, gastrointestinal, hepatic, hematologic, endocrine, neurologic or psychiatric.
* Evidence or history of drug abuse within the past 6 months
* Erosive esophagitis, esophageal ulceration, peptic stricture, Barret's esophagus, or adenocarcinoma of the esophagus on endoscopy.
* History of esophagogastric surgery
* Gastric or duodenal lesions (ulcer, tumor, etc)
* Women who are pregnant or of childbearing age who are not on contraception
* Patients who are unwilling or unable to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00251732
Study Brief:
Protocol Section:
NCT00251732