drugset / Trial / NCT00331045
Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation, by giving overall consideration to the efficacy and safety data in each treatment group. Also, efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopan's safety and efficacy.
Timeline
- Start
- 2006-04
- Primary completion
- 2006-10
- Completion
- 2006-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alvimopan | Small molecule | 0.25 mg | — |
| Subject | Alvimopan | Small molecule | 0.5 mg | — |
| Subject | Alvimopan | Small molecule | 1 mg | — |