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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT03561233
Eligibility Criteria:
Inclusion Criteria:
1. SSc patients aged between 18 and 65 years.
2. Clinically diagnosed as GERD
3. Must not receive any PPI or prokinetic drug within 2 weeks before baseline evaluation
Exclusion Criteria:
1. Pregnancy or lactation
2. Previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis
3. Present of Barrett's esophagus
4. Bedridden and confined to no self-care
5. Evidence of active malignant disease
6. Present of uncontrolled or severe medical problems such as asthma, angina, hepatic or renal diseases
7. Present of active infection that needs systemic antibiotic
8. Allergic history of omeprazole
9. Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03561233
Study Brief:
Protocol Section:
NCT03561233