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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07326904
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 to 60 years at the time of providing written informed consent
* Male or female participants
* History of gastroesophageal reflux disease (GERD) symptoms, including heartburn and/or acid regurgitation
* GERD symptoms confirmed by:
* GERD-Q score greater than 7, and
* Heartburn and/or acid regurgitation occurring on more than 3 days within the last 7 days
* Able to understand the study procedures and complete questionnaires and a daily symptom diary
* Willing and able to provide written informed consent
Exclusion Criteria:
Gastrointestinal conditions:
* Diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis), primary esophageal motility disorders, or pancreatitis
* History of gastric or esophageal surgery affecting acid secretion (except appendectomy, cholecystectomy, or endoscopic polypectomy of benign polyps)
* Alarm symptoms suggestive of gastrointestinal malignancy (e.g., severe dysphagia, odynophagia, gastrointestinal bleeding, anemia, unexplained weight loss), unless malignancy was ruled out
Medical history
* Clinically significant hepatic, renal, endocrine, hematologic, oncologic, or urinary system disease
* History of malignancy within the past 5 years (except non-digestive malignancies that were completely treated with no recurrence for ≥5 years)
* History of psychosis, substance abuse, or alcohol abuse
* Known HIV infection, active hepatitis B, or hepatitis C infection (HCV RNA-positive)
Medication and treatment
* Use of prohibited concomitant medications within 2 weeks prior to enrollment or need for continuous prohibited medication during the study, including:
* Proton pump inhibitors, potassium-competitive acid blockers, H2-receptor antagonists, or other acid-suppressive agents
* Certain psychotropic drugs, anticholinergic drugs, antispasmodics, systemic steroids, or mucoprotective agents
* Use of another investigational product within 4 weeks prior to study drug administration
Laboratory findings
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin ≥2 times the upper limit of normal
* Serum creatinine or blood urea nitrogen ≥2 times the upper limit of normal
Reproductive status
* Pregnant or breastfeeding women
* Women of childbearing potential or male participants who were unwilling to use appropriate contraception during the study
Other
* Known hypersensitivity to the investigational product or comparator drug
* Any condition that, in the opinion of the investigator, made the participant unsuitable for study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07326904
Study Brief:
Protocol Section:
NCT07326904