Phase
Condition
Heartburn (Pediatric)
Non-ulcer Dyspepsia (Nud)
Esophageal Disorders
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
KEY INCLUSION CRITERIA:
- Prior completion of Study E3810-G000-302 or -303. Subjects will need to have healederosive esophagitis (absence of esophageal mucosal breaks or erosions) confirmed by EGD andsustained resolution of heartburn at Visit 4 or 5 of Study E3810-G000-302 or -303.
Exclusion
KEY EXCLUSION CRITERIA:
Esophageal motility disorders (achalasia, scleroderma, or esophageal spasm).
Barrett's esophagus or esophageal stricture.
Use of prescription or non-prescription proton pump inhibitors (PPIs), histaminereceptor antagonists (H2RA), antacids, sucralfate, misoprostol, prokinetics or drugswith significant anticholinergic effects throughout the study.
Subjects who require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs),oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (->; 325 mg/day).
Significant hepatic, renal, respiratory, endocrine, hematologic, neurologic,psychiatric, or cardiovascular system abnormalities that would be likely to interferewith the conduct of the study, the interpretation of study results, or the health ofthe subject during the study.
Any condition that would make the subject, in the opinion of the Investigator orSponsor, unsuitable for the study.
Study Design
Study Description
Connect with a study center
Associates, Ltd.
Moline, Illinois 61265
United StatesSite Not Available
Midwest Clinical
Moline, Illinois 61265
United StatesSite Not Available
Research
Moline, Illinois 61265
United StatesSite Not Available
Moline, Illinois 61265
United StatesSite Not Available
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