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:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT05055128
Eligibility Criteria:
Inclusion Criteria:
1. Body mass index (BMI) ≥ 18 and ≤ 40 kg/m\^2 at screening.
2. Gastro-esophageal reflux disease with endoscopically confirmed esophagitis:
* LA grade C or D ≤7 days before randomization (with or without historical PPI treatment) or
* LA grade A or B ≤7 days before randomization and history of treatment with the standard healing course of PPI for minimum of 8 weeks prior to screening and ≤7 days of non-treatment during this period and at least partial symptom response during the minimum of 8 weeks of PPI treatment.
3. Willing and able to comply with all aspects of the protocol (including capsule swallowing, diary completion, etc.).
4. Capable of signing informed consent form.
Exclusion Criteria:
1. History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease or disorder.
2. Patients with so-called "alarm features" in symptomatology, like odynophagia, severe dysphagia, bleeding, weight loss, anemia, and blood in stool pointing to a possible malignant disease of the gastrointestinal (GI) tract.
3. Present clinically significant psychiatric diagnosis.
4. History of malignancy of any organ system.
5. Presence of esophageal ulcer, stricture, Barrett´s esophagus or suspected esophagitis secondary to infection, inflammatory disease, ingestion of erosive chemicals or history of any surgical or medical condition which might significantly alter the Gastro-oesophageal reflux disease (GERD) status or the absorption, distribution, metabolism or excretion of drugs.
6. Known severe atrophic gastritis.
7. Any planned major surgery within the duration of the study.
8. History of a positive result for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), antibody to Hepatitis B core antigen (anti-HBcAg), or antibody to Hepatitis C virus (anti-HCV) or presence of these findings on screening.
9. History of long QTc syndrome (e.g. QTc ≥450 ms for males and ≥470 ms for females).
10. Cardiac arrhythmias or any clinically significant abnormalities in the resting 12-lead ECG at the time of screening, as judged by the Investigator.
11. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.
12. Current or history of alcohol, drug abuse and/or use of anabolic steroids within 2 years prior to screening.
13. Women who are pregnant or breastfeeding.
14. Patients who have previously participated (completed or withdrawn) in this study CX842A2201.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05055128
Study Brief:
Protocol Section:
NCT05055128