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

Completed · Phase 3 · Has a placebo group

Conditions studied: Esophagitis, Reflux, Esophagitis, Peptic

In brief

The purpose of this study is to assess the ability of once-daily (QD) treatment with dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).

Key facts

Study ID

NCT00321737

Run by

Takeda

People needed

445

Starts

2006-05-01

Expected to finish

2007-05-01

Last updated by the study team

2012-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Tuscon, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Azusa, California, United States
• Study site — Carmichael, California, United States
• Study site — Chula Vista, California, United States
• Study site — Cypress, California, United States
• Study site — Fresno, California, United States
• Study site — Garden Grove, California, United States
• Study site — Harrisburg, California, United States
• Study site — Irvine, California, United States
• Study site — Lancaster, California, United States
• Study site — Mission Hills, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — Pasadena, California, United States
• Study site — San Diego, California, United States
• Study site — San Luis Obispo, California, United States
• Study site — Boulder, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Wheat Ridge, Colorado, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Miami, Florida, United States
• Study site — New Smyma Beach, Florida, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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