Tracking Recovery After Bladder Cancer Surgery with Alvimopan or Placebo
NCT03216525 · RecruitingThis trial looks at how well Alvimopan works for patients having surgery for bladder cancer. The goal is to see if this medicine helps patients recover their bowel function faster than a placebo, which is a dummy treatment. This study will include 136 patients who will be randomly assigned to receive either Alvimopan or a placebo during their recovery after surgery.
Locations and contact
This trial is running at 1 location in the United States. It is currently recruiting.
United States1 location · 1 recruiting
- Brigham and Women's HospitalBoston, MassachusettsRecruiting
Who can join
Adults aged 18 to 85 can join this trial. Both men and women are welcome. To participate, patients must be scheduled for radical cystectomy and urinary diversion. Some people, like those who have had certain surgeries before or have serious health issues, cannot join. The trial team will confirm who is eligible to participate.
What happens during the trial
Participants will be placed in one of two groups by chance. One group will receive Alvimopan, while the other group will receive a matching placebo. Alvimopan is given before and after surgery to see if it helps with bowel recovery. Everyone will take their assigned treatment until they leave the hospital or for a maximum of 7 days.
The trial team
The trial is led by Brigham and Women's Hospital, with Dr. Mark A Preston as the principal investigator. Merck Sharp & Dohme LLC is a collaborator in this study.
Important dates
This trial started on October 1, 2018, and is currently recruiting new participants. It is expected to finish by June 1, 2024.
Additional information
The trial ID is NCT03216525. This is a Phase 3 trial, which means it is looking at how well the treatment works and how safe it is. The trial is FDA-regulated and aims to include about 136 participants.
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