A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy
A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.
2 other identifiers
interventional
280
1 country
20
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2009
Typical duration for phase_4
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2008
CompletedFirst Posted
Study publicly available on registry
July 2, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
July 2, 2015
CompletedJanuary 8, 2016
January 1, 2016
2.8 years
June 27, 2008
September 10, 2013
January 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model
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)
From day of surgery (Day 0) up to 10 days in hospital
Secondary Outcomes (8)
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
Mean Time to Discharge Order Written (DOW) Using KM Estimates
Day of surgery (Day 0) up to 10 days in hospital
Postoperative Length of Stay (LOS)
Day of surgery (Day 0) to the day of hospital DOW
Percentage of Participants Considered Postoperative LOS Responders
Day of surgery (Day 0) up to 7 days after surgery
Percentage of Participants With Postoperative Morbidity (POM)
During hospitalization or within 7 days after discharge
- +3 more secondary outcomes
Study Arms (2)
Alvimopan
EXPERIMENTAL12 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
Placebo
PLACEBO COMPARATOR300 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Saddleback Memorial Medical Center
Laguna Hills, California, 92653, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
University of Miami
Miami, Florida, 33136, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Chicago, Section of Urology MC6038
Chicago, Illinois, 60637, United States
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
University of Minnesota Hospital
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
CRC of Jackson
Jackson, Mississippi, 39202, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
Oregon Health and Science University Knight Cancer Institute
Portland, Oregon, 97239, United States
Vanderbilt University Medical Center, Department of Urology Surgery
Nashville, Tennessee, 37232, United States
The Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 24630419DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Clinical Research
- Organization
- Cubist Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Lee Techner, DPM
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2008
First Posted
July 2, 2008
Study Start
March 1, 2009
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
January 8, 2016
Results First Posted
July 2, 2015
Record last verified: 2016-01