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 @ 1:55 PM
Ignite Modification Date:
2025-12-24 @ 1:55 PM
NCT ID:
NCT01149395
Eligibility Criteria:
Inclusion Criteria: (all responses must be Yes)
* Between 18 and 75 years of age
* Male or non-pregnant, non-lactating female
* Willing and able to undergo endoscopy with biopsies and a blood draw
* Willing and able to discontinue use of PPIs for at least 1 month prior to the study start date
* Endoscopy-negative heartburn of moderate severity at least 3 times-a-week for 3 months
Exclusion Criteria:(all responses must be No)
* History of:
* Barrett's Esophagus
* Erosive Esophagus
* Zollinger Ellison syndrome
* bleeding disorder
* upper gastrointestinal bleeding or malignancy
* esophageal motor disorder
* esophageal stricture
* esophageal varices
* Had the following surgeries:
* organ transplant
* gastric or esophageal surgery for the treatment of: Esophageal Cancer, Achalasia, Gastroesophageal Reflux Disease (GERD); i.e. Nissen Fundoplication
* Have any of the following:
* Current malabsorption
* inflammatory bowel disease
* severe heart-lung-liver or renal cerebrovascular disease
* known hypersensitivity to PPIs
* Currently taking any of the following medications:
* Quinidine
* quinine
* benzodiazepines
* antineoplastic agents
* dilantin
* warfarin
* non-steroidal anti-inflammatory drugs
* narcotics
* prostaglandins
* salicylates (except baby aspirin for cardiovascular protection)
* H2-receptor antagonists
* PPIs other than study agent
* steroids
* promotability drugs
* sucralfate
* KCl
* anti-tuberculosis medication
* oral biphosphonates
* drugs requiring acid for absorption (iron, ampicillin, digoxin and ketoconazole)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01149395
Study Brief:
Protocol Section:
NCT01149395