drugset / Trial / NCT00978016
A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study is to evaluate efficacy and safety of arbaclofen placarbil (XP19986) versus placebo as adjunctive therapy in subjects with troublesome GERD symptoms despite therapy with approved doses of a Proton Pump Inhibitor (PPI).
Timeline
- Start
- 2009-09
- Primary completion
- 2010-12
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Arbaclofen Placarbil | Small molecule | 20 mg | — |
| Subject | Arbaclofen Placarbil | Small molecule | 30 mg | — |
| Subject | Arbaclofen Placarbil | Small molecule | 40 mg | — |
| Background | Dexlansoprazole | Other / unclassified | 30 mg | — |
| Background | Dexlansoprazole | Other / unclassified | 60 mg | — |
| Background | Esomeprazole | Small molecule | 20 mg | — |
| Background | Esomeprazole | Small molecule | 40 mg | — |
| Background | Lansoprazole | Other / unclassified | 15 mg | — |
| Background | Lansoprazole | Other / unclassified | 30 mg | — |
| Background | Omeprazole | Other / unclassified | 20 mg | — |
| Background | Omeprazole | Other / unclassified | 40 mg | — |
| Background | Omeprazole/sodium bicarbonate | Unknown | 20 mg | — |
| Background | Omeprazole/sodium bicarbonate | Unknown | 40 mg | — |
| Background | Pantoprazole | Other / unclassified | 20 mg | — |
| Background | Pantoprazole | Other / unclassified | 40 mg | — |
| Background | Rabeprazole | Small molecule | 20 mg | — |