A Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy - Full Text View

Sponsors and Collaborators:	Adolor Corporation GlaxoSmithKline
Information provided by:	Adolor Corporation
ClinicalTrials.gov Identifier:	NCT00708201

Purpose

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

Condition	Intervention	Phase
Postoperative Ileus	Drug: alvimopan Drug: Placebo	Phase IV

Drug Information available for: Alvimopan LY246736

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Adolor Corporation:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	280
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Alvimopan 12 mg	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
B: Placebo Comparator 300 mg polyethylene glycol in a No. 1 Swedish Orange gelatin capsule	Drug: Placebo 300 mg polyethylene glycol

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708201

Contacts

Contact: Lee Techner, DPM

484-595-1008

ltechner@adolor.com

Locations

United States, Illinois
University of Chicago, Section of Urology MC6038
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

Adolor Corporation

GlaxoSmithKline

Investigators

Study Director:

Lee Techner, DPM

Adolor Corporation

More Information

Responsible Party:	Adolor Corporation ( Lee Techner, DPM )
Study ID Numbers:	14CL403
Study First Received:	June 27, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00708201
Health Authority:	United States: Food and Drug Administration

Keywords provided by Adolor Corporation:

ileus
POI

Study placed in the following topic categories:

Intestinal Obstruction
Ileus
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on January 14, 2009