Clinical trial NCT00708201: A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy
Official title: A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Ileus
Keywords: ileus
POI
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are:

* to evaluate the effect of alvimopan on hospital length of stay
* to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities
* to evaluate the overall and cardiovascular safety of alvimopan


Eligibility criteria: Inclusion Criteria:

* are either Male or Female at least 18 years of age
* are scheduled for radical cystectomy
* are scheduled to receive postoperative pain management with intravenous participant-controlled opioid analgesics

Exclusion Criteria:

* are scheduled for a partial cystectomy
* have taken more than 3 doses of opioids (oral or parenteral) within 7 days before the day of surgery

Primary outcomes:
measure: Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model
timeFrame: From day of surgery (Day 0) up to 10 days in hospital
Secondary outcomes:
measure: Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model
timeFrame: Day of surgery (Day 0) up to 10 days in hospital
measure: Mean Time to Discharge Order Written (DOW) Using KM Estimates
timeFrame: Day of surgery (Day 0) up to 10 days in hospital
measure: Postoperative Length of Stay (LOS)
timeFrame: Day of surgery (Day 0) to the day of hospital DOW
measure: Percentage of Participants Considered Postoperative LOS Responders
timeFrame: Day of surgery (Day 0) up to 7 days after surgery
measure: Percentage of Participants With Postoperative Morbidity (POM)
timeFrame: During hospitalization or within 7 days after discharge
measure: Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points
timeFrame: Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7
measure: Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points
timeFrame: Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7
measure: Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events
timeFrame: Baseline to 30 days post discharge
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago, Section of Urology MC6038
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: CRC of Jackson
state: Mississippi
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University Knight Cancer Institute
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Department of Urology Surgery
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
name: Lee Techner, DPM
role: STUDY_DIRECTOR
References:
citation: Lee CT, Chang SS, Kamat AM, Amiel G, Beard TL, Fergany A, Karnes RJ, Kurz A, Menon V, Sexton WJ, Slaton JW, Svatek RS, Wilson SS, Techner L, Bihrle R, Steinberg GD, Koch M. Alvimopan accelerates gastrointestinal recovery after radical cystectomy: a multicenter randomized placebo-controlled trial. Eur Urol. 2014 Aug;66(2):265-72. doi: 10.1016/j.eururo.2014.02.036. Epub 2014 Feb 26.