Clinical trial: dexlansoprazole MR, a proton pump inhibitor with dual delayed-release technology, effectively controls symptoms and prevents relapse in patients with healed erosive oesophagitis D. C. METZ*, C. W. HOWDEN  , M. C. PEREZ à , L. LARSEN§, J. O’NEIL à & S. N. ATKINSON à *University of Pennsylvania School of Medicine, Division of Gastroenterol- ogy, Philadelphia, PA, USA;  Northwestern University Feinberg School of Medicine, Division of Gastroenterology, Chicago, IL, USA; àResearch & Development, Takeda Global Research & Development Center, Inc., Deerfield, IL, USA (TAP Pharmaceutical Products Inc., Lake Forest, IL, is now a part of Takeda Global Research & Development Cen- ter, Inc.); §Research & Development, TAP Pharmaceutical Products Inc., Lake Forest, IL, USA (now a part of Takeda Global Research & Develop- ment Center, Inc.) Correspondence to: Dr S. N. Atkinson, Vice President, Clinical Sciences, Takeda Global Research & Development Center, Inc., 675 N Field Drive, Lake Forest, IL 60045, USA. E-mail: stuart.atkinson@tgrd.com Publication data Submitted 30 December 2008 First decision 2 January 2009 Resubmitted 2 February 2009 Accepted 3 February 2009 Epub Accepted Article 7 February 2009 SUMMARY Background Dexlansoprazole MR heals all grades of erosive oesophagitis (EO). Aim To assess efficacy and safety of dexlansoprazole MR in maintaining healed EO and heartburn relief. Methods In this randomized, double-blind trial, 445 patients with healed EO received dexlansoprazole MR 30 mg or 60 mg or placebo once daily for 6 months. This trial assessed maintenance of endoscopic healing (pri- mary endpoint) and continued symptom relief based on daily diaries (secondary endpoints). Results Dexlansoprazole MR 30 mg and 60 mg were superior to placebo for maintaining healed EO (P < 0.0025; Hochberg’s). By life-table analysis, maintenance rates were 75%, 83% and 27% for dexlansoprazole MR 30 mg, 60 mg and placebo respectively. Crude maintenance rates were 66% for both dexlansoprazole MR doses and 14% for placebo. Dexlan- soprazole MR controlled heartburn (medians of 91–96% for 24-h heart- burn-free days, 96–99% for heartburn-free nights). The only more common adverse event occurring at a significantly higher rate in dex- lansoprazole MR groups than placebo when analysed per patient- months of exposure was upper respiratory tract infection. Conclusions Dexlansoprazole MR effectively maintained EO healing and symptom relief; most patients were heartburn-free for >90% of days. Both doses were well tolerated. Aliment Pharmacol Ther 29, 742–754 Alimentary Pharmacology & Therapeutics 742 ª 2009 Takeda Global Research & Development Center, Inc. doi:10.1111/j.1365-2036.2009.03954.x