drugset / Trial / NCT01005251
Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to examine which of the investigated doses of AZD3355 is optimal for treatment of these patients. This study will also measure levels of drug in the blood and see how well it is tolerated.
Timeline
- Start
- 2009-10
- Primary completion
- 2010-07
- Completion
- 2010-07
Publications
- Shaheen NJ, Denison H, Bjorck K, Silberg DG. Esophageal mucosal breaks in gastroesophageal reflux disease partially responsive to proton pump inhibitor therapy. Am J Gastroenterol. 2013 Apr;108(4):529-34. doi: 10.1038/ajg.2012.447. Epub 2013 Jan 15.
- Shaheen NJ, Denison H, Bjorck K, Karlsson M, Silberg DG. Efficacy and safety of lesogaberan in gastro-oesophageal reflux disease: a randomised controlled trial. Gut. 2013 Sep;62(9):1248-55. doi: 10.1136/gutjnl-2012-302737. Epub 2012 Jun 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | lesogaberan | Small molecule | 60 mg | Oral |
| Subject | lesogaberan | Small molecule | 120 mg | Oral |
| Subject | lesogaberan | Small molecule | 180 mg | Oral |
| Subject | lesogaberan | Small molecule | 240 mg | Oral |