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 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 12:09 AM
NCT ID:
NCT00251758
Eligibility Criteria:
Inclusion Criteria:
* Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.
* History of episodes of heartburn for 6 months or longer prior to screening.
* History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.
Exclusion Criteria:
* Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study
* Erosive Esophagitis seen on endoscopy during study screening.
* Co-existing diseases affecting the esophagus.
* Abnormal laboratory values that suggest significant clinical disease.
* Known acquired immunodeficiency syndrome (AIDS)
* Females pregnant or lactating.
* History of Alcohol abuse.
* History of Cancer within 3 years prior to screening.
* Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
* Use of antacids (except for study supplied Gelusil® )
* Use of drugs with significant anticholinergic effects
* Need for continuous anticoagulant (blood thinner) therapy
* Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
* History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
* Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition
* History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer
* Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
* Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00251758
Study Brief:
Protocol Section:
NCT00251758