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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00708201
First received: June 27, 2008
Last updated: June 4, 2015
Last verified: June 2015
Results First Received: September 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Postoperative Ileus
Interventions: Drug: Alvimopan
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo A single dose of placebo was 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 12 mg A single dose of alvimopan 12 milligrams (mg) was 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 alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.

Participant Flow:   Overall Study
    Placebo     Alvimopan 12 mg  
STARTED     137     143  
Received at Least 1 Dose of Study Drug     130     137  
COMPLETED     130     137  
NOT COMPLETED     7     6  
Adverse Event                 4                 4  
Withdrawal by Subject                 1                 1  
Lost to Follow-up                 2                 0  
Protocol Violation                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All study participants

Reporting Groups
  Description
Placebo A single dose of placebo was 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 12 mg A single dose of alvimopan 12 milligrams (mg) was 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 alvimopan 12 mg was given twice a day for a maximum of 7 days in hospital after surgery.
Total Total of all reporting groups

Baseline Measures
    Placebo     Alvimopan 12 mg     Total  
Number of Participants  
[units: participants]
  137     143     280  
Age  
[units: Years]
Mean (Standard Deviation)
  63.9  (9.84)     66.3  (10.93)     65.1  (10.39)  
Gender  
[units: participants]
     
Female     27     30     57  
Male     110     113     223  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     3     1     4  
Not Hispanic or Latino     134     142     276  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     1     1  
Black or African American     6     4     10  
White     131     138     269  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures
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1.  Primary:   Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model   [ Time Frame: From day of surgery (Day 0) up to 10 days in hospital ]

2.  Secondary:   Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model   [ Time Frame: Day of surgery (Day 0) up to 10 days in hospital ]

3.  Secondary:   Mean Time to Discharge Order Written (DOW) Using KM Estimates   [ Time Frame: Day of surgery (Day 0) up to 10 days in hospital ]

4.  Secondary:   Postoperative Length of Stay (LOS)   [ Time Frame: Day of surgery (Day 0) to the day of hospital DOW ]

5.  Secondary:   Percentage of Participants Considered Postoperative LOS Responders   [ Time Frame: Day of surgery (Day 0) up to 7 days after surgery ]

6.  Secondary:   Percentage of Participants With Postoperative Morbidity (POM)   [ Time Frame: During hospitalization or within 7 days after discharge ]

7.  Secondary:   Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points   [ Time Frame: Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7 ]

8.  Secondary:   Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points   [ Time Frame: Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7 ]

9.  Secondary:   Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events   [ Time Frame: Baseline to 30 days post discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vice President, Clinical Research
Organization: Cubist Pharmaceuticals
phone: (781) 860-8660


No publications provided by Cubist Pharmaceuticals

Publications automatically indexed to this study:

Responsible Party: Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00708201     History of Changes
Other Study ID Numbers: 14CL403
Study First Received: June 27, 2008
Results First Received: September 10, 2013
Last Updated: June 4, 2015
Health Authority: United States: Food and Drug Administration