A Randomized, Double-blind, Single-Center Trial of Alvimopan (Entereg) Versus Placebo in Patients Undergoing Radical Cystectomy and Urinary Diversion on an Enhanced Recovery After Surgery ERAS Protocol
Who is this study for? Patients undergoing radical cystectomy
What treatments are being studied? Alvimopan
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Patients undergoing radical cystectomy and urinary diversion via open or robotic approach.
• Man or woman between the ages of 18 and 85.
• American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4
• Ileal conduit or ileal neobladder urinary diversion
• Able to understand the study procedures, agreed to participate in the study program, and voluntarily provided informed consent
Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Martin Barylak
mbarylak@bwh.harvard.edu
6175258274
Backup
Anjali Vasavada
AVASAVADA@BWH.HARVARD.EDU
6175258274
Time Frame
Start Date: 2018-10-01
Estimated Completion Date: 2024-06-01
Participants
Target number of participants: 136
Treatments
Active_comparator: Oral Alvimopan
Oral Alvimopan (Entereg, Merck) 12 mg between 30 minutes and 3 hours before surgery start and twice-daily oral doses postoperatively beginning on day one (AM and PM dosing) until hospital discharge or a maximum of 7 days (15 in-hospital doses).
Placebo_comparator: Matching Placebo
Matching placebo between 30 minutes and 3 hours before surgery start and twice-daily oral doses postoperatively beginning on day one (AM and PM dosing) until hospital discharge or a maximum of 7 days (15 in-hospital doses).
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Merck Sharp & Dohme LLC