drugset / Trial / NCT00255190
Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.
Timeline
- Start
- 2006-01
- Primary completion
- 2008-06
- Completion
- 2008-06
Publications
- 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.
- Results Dabholkar AH, Han C, Paris MM, Perez MC, Atkinson SN, Peura DA. The 12-month safety profile of dexlansoprazole, a proton pump inhibitor with a dual delayed release formulation, in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2011 Feb;33(3):366-77. doi: 10.1111/j.1365-2036.2010.04519.x. Epub 2010 Nov 30.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexlansoprazole | Other / unclassified | 60 mg | Oral |
| Subject | Dexlansoprazole | Other / unclassified | 90 mg | Oral |