At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 146 enrolled
Drug / intervention
Alvimopan +1 moredrug
Likely dose
Alvimopan 12mgfrom 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.
Accelerating Gastrointestinal Recovery in Women Undergoing Staging and/or Debulking Surgery for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: A Randomized, Double-Blind, Placebo-Controlled Trial
In Brief
A Phase 3 clinical trial evaluating Alvimopan and Placebo for Ovarian Cancer and 2 related conditions. Completed, enrolled 146 participants across 1 site.
Detailed Summary
This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
CountriesUnited States
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartJan 2013
Primary CompletionAug 2015
Study CompletionOct 2015
TodayJul 2026
First PostedOct 11, 2012
Enrollment StartJan 1, 2013
Primary CompletionAug 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 13.7 years ago
Interventions
Alvimopandrug
Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.
Placebodrug
Perioperative administration of placebo, at same dosing interval as study drug.