Last updated: March 28, 2022
Sponsor: Eisai Inc.
Overall Status: Completed
Phase
3
Condition
Esophageal Disorders
Gastroparesis
Non-ulcer Dyspepsia (Nud)
Treatment
N/AClinical Study ID
NCT00838526
E3810-G000-305
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Prior completion of Study E3810-G000-301 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-G000-301 or -303.
Exclusion
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
Total Participants: 240
Study Start date:
August 31, 2008
Estimated Completion Date:
December 31, 2009
Study Description
Connect with a study center
Ltd.
Moline, Illinois 61265
United StatesSite Not Available
Midwest Clinical
Moline, Illinois 61265
United StatesSite Not Available
Research Associates
Moline, Illinois 61265
United StatesSite Not Available
Moline, Illinois 61265
United StatesSite Not Available
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