Lead Sponsor

Takeda

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.

•Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study.
•Use of antacids (except for study supplied) throughout the study.
•Use of drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
•Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
•Need for continuous anticoagulant therapy.
•Evidence of uncontrolled systemic disease.
•Subjects who have participated in either maintenance study (T-EE04-086 \[NCT00255164\] or T-EE04-087 \[NCT00255151\]).
•Subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.

Related studies

NCT02463643 · Esophagitis, Reflux

NCT00255151 · Esophagitis, Reflux, Esophagitis, Peptic

NCT00255164 · Esophagitis, Reflux, Esophagitis, Peptic

NCT00251693 · Esophagitis, Reflux, Esophagitis, Peptic

NCT00251719 · Esophagitis, Reflux, Esophagitis, Peptic

Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis