At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 524 enrolled
Drug / intervention
Methylnaltrexone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
In Brief
A Phase 3 clinical trial evaluating Methylnaltrexone and Placebo for Post-Operative Ileus (POI). Completed, enrolled 524 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Operative Ileus (POI)
CountriesUnited States
CollaboratorsWyeth is now a wholly owned subsidiary of Pfizer
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedNov 2006
Primary CompletionFeb 2008
TodayJul 2026
First PostedNov 20, 2006
Enrollment StartOct 31, 2006
Primary CompletionFeb 29, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.6 years ago
Interventions
Methylnaltrexonedrug
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
Placebodrug
Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arm.