drugset / Trial / NCT00321737
Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis
RandomizedParallel-groupTriple-blindTreatment
Summary
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).
Timeline
- Start
- 2006-05
- Primary completion
- 2007-05
- Completion
- 2007-05
Outcome
Met primary endpoint
paper Dexlansoprazole MR 30 mg and 60 mg were superior to placebo for maintaining healed EO (P < 0.0025; Hochberg's). PMID 19210298 ↗
registry Placebo QD vs Dexlansoprazole MR 30 mg QD; p <0.00001; Fisher Exact NCT00321737 ↗
registry Placebo QD vs Dexlansoprazole MR 60 mg QD; p <0.00001; Log Rank NCT00321737 ↗
Publications
- Results Metz DC, Howden CW, Perez MC, Larsen L, O'Neil J, Atkinson SN. 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. Aliment Pharmacol Ther. 2009 Apr 1;29(7):742-54. doi: 10.1111/j.1365-2036.2009.03954.x. Epub 2009 Feb 7.
- Results Peura DA, Metz DC, Dabholkar AH, Paris MM, Yu P, Atkinson SN. Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1010-21. doi: 10.1111/j.1365-2036.2009.04137.x. Epub 2009 Sep 4.
- Results Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epub 2010 Feb 27.
- Results Friedlander EA, Pallentino J, Miller SK, VanBeuge SS. The evolution of proton pump inhibitors for the treatment of gastroesophageal reflux disease. J Am Acad Nurse Pract. 2010 Dec;22(12):674-83. doi: 10.1111/j.1745-7599.2010.00578.x. Epub 2010 Nov 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexlansoprazole | Other / unclassified | 30 mg | Oral |
| Subject | Dexlansoprazole | Other / unclassified | 60 mg | Oral |