drugset / Trial / NCT00441766
Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain
RandomizedParallel-groupTriple-blindTreatment
Summary
This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.
Timeline
- Start
- 2007-03
- Primary completion
- 2008-02
- Completion
- 2008-02
Outcome
Outcome not reported
Stopped: “Study was terminated due to company decision after Part A. Part B was never conducted”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | REZATOMIDINE | Small molecule | 3 mg | Oral |
| Subject | REZATOMIDINE | Small molecule | 20 mg | Oral |
| Subject | REZATOMIDINE | Small molecule | 60 mg | Oral |
| Subject | REZATOMIDINE | Small molecule | 100 mg | Oral |
| Subject | REZATOMIDINE | Small molecule | 160 mg | Oral |