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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT00626535
Eligibility Criteria:
Inclusion Criteria:
* History of episodes of heartburn and upper abdominal pain for 6 months or longer.
* Episodes of heartburn 2 or more days during the 7 days prior to the screening visit. Moderate or severe upper abdominal pain on at least 3 out of the 7 consecutive days of the run-in period.
* A normal endoscopy within 14 days of Visit 1 of between Run-in and randomization.
Exclusion Criteria:
* Subjects with pain likely to be due to irritable bowel syndrome (IBS)
* History of esophageal, gastric or duodenal surgery, except for closure of an ulcer.
* History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
* Further diseases / conditions, as listed in the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00626535
Study Brief:
Protocol Section:
NCT00626535