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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT01135368
Eligibility Criteria:
Inclusion Criteria:
* Had Gastro Esophageal Reflux disease with or without oesophagitis.
* Had a history of heartburn at least for 5 days per week during the past 6 months or was receiving long-term treatment with a proton pump inhibitor and during two weeks (without proton pump inhibitor treatment) prior to enrolment.
Exclusion Criteria:
* History of surgery of stomach or oesophagus.
* Gastric ulcer (can be included after healing of gastric ulcer).
* Duodenal ulcer (can be included after healing of duodenal ulcer).
* Bleeding (melena, hematemesis).
* Severe concomitant disease (cancer, cardiovascular, renal, hepatic diseases).
* Barrett oesophagus with dysplasia.
* Complicated esophagitis (oesophageal strictures or ulcers).
* Treatment with proton pump inhibitor or Histamine receptor 2 (H2)antagonists within the previous two weeks.
* Pregnancy, wish to become pregnant, breast feeding.
* Treatment with non steroidal anti-inflammatory drugs, treatment with acetylsalicylic acid (aspirin) \> 100 mg/day.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01135368
Study Brief:
Protocol Section:
NCT01135368