A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy
- Registration Number
- NCT00708201
- Lead Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 300 mg polyethylene glycol in a capsule Administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery. Alvimopan Alvimopan 12 milligrams (mg) Alvimopan, 12mg, capsule. Administered orally. One 30 minutes to 5 hours before the scheduled start of surgery on Day 0, and twice daily beginning on Postoperative Day 1 (POD 1) until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment
- Primary Outcome Measures
Name Time Method Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model From day of surgery (Day 0) up to 10 days in hospital Time to achieve recovery of gastrointestinal (GI) function as measured by a composite endpoint of both upper GI recovery (toleration of solid food) and lower GI recovery (first bowel movement \[BM\]) using KM Estimates and Cox PH Model. This endpoint was referred to as GI2. GI2 was calculated as GI2 = maximum (max) (solids, BM). The KM estimate reported below is biased because of the censoring of the last observation.
Censoring Rules for Study Participants who:
Completed: the censored time for the event was determined as: censored time = minimum \[maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration\].
Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)
- Secondary Outcome Measures
Name Time Method Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model Day of surgery (Day 0) up to 10 days in hospital The endpoint of "time to ready for discharge" was based solely on the recovery of GI function as determined by the surgeon. The KM estimate reported below is biased because of the censoring of the last observation.
Censoring Rules for Study Participants who:
Completed: the censored time for the event was determined as: censored time = minimum \[maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration\].
Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)Mean Time to Discharge Order Written (DOW) Using KM Estimates Day of surgery (Day 0) up to 10 days in hospital The KM estimate reported below is biased because of the censoring of the last observation.
Censoring Rules for Study Participants who:
Completed: the censored time for the event was determined as: censored time = minimum \[maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration\].
Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)Postoperative Length of Stay (LOS) Day of surgery (Day 0) to the day of hospital DOW The postoperative LOS was determined by the difference between the date of hospital DOW and the date of surgery; that is, the postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery).
Percentage of Participants Considered Postoperative LOS Responders Day of surgery (Day 0) up to 7 days after surgery A participant was considered a postoperative LOS responder if the postoperative LOS was less than or equal to 7 days. The postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery). Participants with missing data were considered nonresponders.
Percentage of Participants With Postoperative Morbidity (POM) During hospitalization or within 7 days after discharge POM was defined as the need for postoperative nasogastric (NG) tube insertion, hospital stay prolonged because of postoperative ileus (POI) (as determined by the investigator), or readmission (readmiss) to the hospital (hosp) for POI within 7 days (d) after discharge.
Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7 Time to achieve recovery of GI function was measured by a composite endpoint of time to first BM and time to tolerate first solid food (solids). This endpoint was referred to as GI2, and GI2 was calculated as follows: GI2 = max (solids, BM). GI2 responders were defined as those participants who met all the following criteria: achieved GI2 by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. Postsurgery Days (PSD) were measured in 24 hour increments after surgery.
Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7 DOW responders were defined as those participants who met all the following criteria: achieved DOW by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. PSD were measured in 24 hour increments after surgery.
Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events Baseline to 30 days post discharge CV events of interest included congestive heart failure, CV death, cerebrovascular accident, myocardial infarction, serious arrhythmia, and unstable angina. CV events were adjudicated by a blinded external committee.
Trial Locations
- Locations (20)
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Miami
🇺🇸Miami, Florida, United States
University of Minnesota Hospital
🇺🇸Minneapolis, Minnesota, United States
Saddleback Memorial Medical Center
🇺🇸Laguna Hills, California, United States
Indiana University Hospital
🇺🇸Indianapolis, Indiana, United States
University of Chicago, Section of Urology MC6038
🇺🇸Chicago, Illinois, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
CRC of Jackson
🇺🇸Jackson, Mississippi, United States
University of North Carolina Hospitals
🇺🇸Chapel Hill, North Carolina, United States
Vanderbilt University Medical Center, Department of Urology Surgery
🇺🇸Nashville, Tennessee, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
H. Lee Moffitt Cancer Center & Research Institute
🇺🇸Tampa, Florida, United States
Oregon Health and Science University Knight Cancer Institute
🇺🇸Portland, Oregon, United States