drugset / Trial / NCT00401375
Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
Phase 3
Completed
524 enrolled
Bausch Health Americas, Inc.
Wyeth is now a wholly owned subsidiary of Pfizer · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.
Timeline
- Start
- 2006-10-31
- Primary completion
- 2008-02-29
- Completion
- 2008-02-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylnaltrexone | Other / unclassified | 12 mg | Intravenous |
| Subject | Methylnaltrexone | Other / unclassified | 24 mg | Intravenous |