Phase 4
N=280
A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy
Postoperative Ileus
Bottom Line
View on ClinicalTrials.gov: NCT00708201 ↗Enrolled (actual)
280
Serious AEs
42.1%
Results posted
Jul 2015
Primary outcome: Primary: Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model — 164.2; 132.7 Hours — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Alvimopan (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model |
164.2; 132.7 | <0.0001 sig |
| SECONDARY Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model |
154.7; 130.0 | <0.001 sig |
| SECONDARY Mean Time to Discharge Order Written (DOW) Using KM Estimates |
188.4; 166.0 | <0.001 sig |
| SECONDARY Postoperative Length of Stay (LOS) |
10.07; 7.44 | <0.01 sig |
| SECONDARY Percentage of Participants Considered Postoperative LOS Responders |
48.5; 67.1 | <0.01 sig |
| SECONDARY Percentage of Participants With Postoperative Morbidity (POM) |
29.1; 8.4; 24.6; 7.7; 21.8; 3.5 | <0.001 sig |
| SECONDARY Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points |
9.7; 25.2; 27.6; 53.8; 42.5; 75.5 | <0.0001 sig |
| SECONDARY Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points |
0.7; 2.8; 17.9; 14; 32.1; 39.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events |
15.3; 8.4; 2.9; 0.0; 2.9; 0.7 | 0.0946 |
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
Data sourced from ClinicalTrials.gov (NCT00708201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.