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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT03216525
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Alvimopan — DRUG
    To determine if Alvimopan during radical cystectomy with urinary diversion results in faster return of bowel function.
  • Placebo — DRUG
    To determine if placebo during radical cystectomy with urinary diversion results in faster return of bowel function.

Study Details

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.

Key Dates

Start date
Oct 1, 2018
Status verified
Sep 2023
Primary completion
Dec 1, 2023
Completion
Jun 1, 2024

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Time to Return of Bowel Function [ Time Frame: From Day of surgery (Day 0) to Day 30 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Martin Barylak
[email protected]
617-525-8274
Mark A Preston, MD (PRINCIPAL_INVESTIGATOR)

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