A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy

Postoperative Ileus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708201
• Other study ID #: 3753-002
• Secondary ID: 14CL403
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2008
• Last updated: January 6, 2016
• Start date: March 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2016
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Drug:
• Alvimopan

• Placebo

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Colorado Hospital	Aurora	Colorado
United States	Bend Memorial Clinic	Bend	Oregon
United States	University of North Carolina Hospitals	Chapel Hill	North Carolina
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	University of Chicago, Section of Urology MC6038	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	Indiana University Hospital	Indianapolis	Indiana
United States	CRC of Jackson	Jackson	Mississippi
United States	Saddleback Memorial Medical Center	Laguna Hills	California
United States	University of Miami	Miami	Florida
United States	University of Minnesota Hospital	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center, Department of Urology Surgery	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Oregon Health and Science University Knight Cancer Institute	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model	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)	Day of surgery (Day 0) up to 10 days in hospital	No
Secondary	Mean Time to Discharge Order Written (DOW) Using KM Estimates	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)	Day of surgery (Day 0) up to 10 days in hospital	No
Secondary	Postoperative Length of Stay (LOS)	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).	Day of surgery (Day 0) to the day of hospital DOW	No
Secondary	Percentage of Participants Considered Postoperative LOS Responders	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.	Day of surgery (Day 0) up to 7 days after surgery	No
Secondary	Percentage of Participants With Postoperative Morbidity (POM)	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.	During hospitalization or within 7 days after discharge	No
Secondary	Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points	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.	Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7	No
Secondary	Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points	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.	Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7	No
Secondary	Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events	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.	Baseline to 30 days post discharge	Yes