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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT00237367
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of GERD with symptoms for at least 6 months with at least 3 episodes a week and one of those at nighttime
* in generally good health
* stop any previous similar (proton pump inhibitor) therapy at least 10 days before screening
* weigh within normal weight for one's height
* able to tolerate a nasogastric tube (pH probe assembly that goes through the nose into the stomach) for 48 hours on 2 different occasions
* esophageal acid exposure of at least 10% on a 24-hour pH monitoring study performed within the 24 months prior to screening
* Helicobacter pylori (an infection) negative
* willing to take only TUMS antacid as rescue medicine during the washout period
Exclusion Criteria:
* History of a serious medical condition
* significant gastrointestinal illness other than GERD
* ulcer at any time in the past
* difficulty swallowing
* history of gastrointestinal disease (including bleeding)
* use of any medication that changes acid secretion or gastrointestinal movement in the past 14 days
* use of any drugs on a list of prohibited drugs within 1 month
* chronic use of pain relieving medications (NSAIDs or COX-2 inhibitors)
* pregnant or breast-feeding
* cancer diagnosis or treatment (except for superficial skin cancers)
* abusing drugs or alcohol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00237367
Study Brief:
Protocol Section:
NCT00237367