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Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol

StatusRecruiting
PhasePhase 3
Started2018-10-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 28, 2023 (before its estimated December 1, 2023 completion). Its status may not reflect the trial's current state.

Amendment history

2025-11-04
Study Status, Outcome Measures, Document Section, Baseline Characteristics, Outcome Measures (Results), Adverse Events v6
Secondary endpoints3 entries, revised
Time to GI2 Recovery by Surgical Approach (Open vs. Robotic Radical Cystectomy)
2025-09-23
Recruiting→Completed Study Status, Study Design, Outcome Measures, Contacts/Locations, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats, More Information v5
Trial statusRecruiting→Completed
Primary completion dateestimated 2023-12-01→confirmed 2025-06-30
Completion dateestimated 2024-06-01→confirmed 2025-06-30
Enrollment targetestimated 136→confirmed 134
Secondary endpoints6 to 3 entries
Post-operative Morbidity Readmission to Hospital Cost Analysis
Study sitesdetails revised at 1 of 1 site
2023-09-26
Study Status v4
Primary completion date2021-12-01→2023-12-01
Completion date2021-12-01→2024-06-01
2021-07-19
Study Status v3
Primary completion date2021-01-01→2021-12-01
Completion date2021-07-01→2021-12-01
2020-07-09
Study Status, Sponsor/Collaborators v2
Collaborators+23 characters
Merck Sharp & Dohme LLC
2020-01-29
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2019-04→2021-01-01
Completion date2020-04→2021-07-01
Start dateestimated 2017-07→confirmed 2018-10-01
Study sites0→1
2017-07-11
Original filing
To determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in quicker return of bowel function (GI-2 recovery = time to upper \[first toleration of solid food\] and lower \[first bowel movement\] gastrointestinal recovery) compared to placebo.
Trial Details
NCT Number NCT03216525
Lead Sponsor Brigham and Women's Hospital
Collaborators: Merck Sharp & Dohme LLC
Conditions Bladder Cancer
Enrollment 136 participants
Start Date 2018-10-01
Primary Completion 2023-12-01 (estimated)
Study Completion 2024-06-01 (estimated)
Updated on ClinicalTrials.gov 2023-09-28