Efficacy and Safety of Dexlansoprazole MR 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) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).

Key facts

Study ID

NCT00255164

Run by

Takeda

People needed

451

Starts

2006-01-01

Expected to finish

2006-11-01

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 TEE04-085 (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.
• Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
• Need for continuous anticoagulant therapy.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Chula Vista, California, United States
• Study site — Fullerton, California, United States
• Study site — Garden Grove, California, United States
• Study site — Irvine, California, United States
• Study site — Lancaster, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mission Hills, California, United States
• Study site — Palm Springs, California, United States
• Study site — Redwood City, 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 — Lone Tree, Colorado, United States
• Study site — Wheat Ridge, Colorado, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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