Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Cubist Pharmaceuticals Identifier:
First received: June 27, 2008
Last updated: March 1, 2012
Last verified: March 2012

June 27, 2008
March 1, 2012
March 2009
January 2012   (final data collection date for primary outcome measure)
Time to achieve recovery of both upper and lower GI function as measured by a composite endpoint of time to the first bowel movement and time to tolerate first solid food. This endpoint is referred to as GI2. [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00708201 on Archive Site
  • Time to ready for discharge [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]
  • Time to discharge order written [ Time Frame: Up to 10 days ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]
  • incidence of adverse events [ Time Frame: up to 30 days or until resolution ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
A Study of Alvimopan for the Management of Postoperative Ileus in Subjects 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.

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
Not Provided
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Ileus
  • Drug: alvimopan
    Alvimopan, 12mg, capsule. One 30 minutes to 5 hours before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment
    Other Names:
    • ADL2698
    • Entereg
  • Drug: Placebo
    300 mg polyethylene glycol
  • Experimental: A
    Alvimopan 12 mg
    Intervention: Drug: alvimopan
  • Placebo Comparator: B
    300 mg polyethylene glycol in a No. 1 Swedish Orange gelatin capsule
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2012
January 2012   (final data collection date for primary outcome measure)

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 patient-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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
Cubist Pharmaceuticals
Cubist Pharmaceuticals
Not Provided
Study Director: Lee Techner, DPM Cubist Pharmaceuticals
Cubist Pharmaceuticals
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP