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Study Summary
No. 2009-0244:.......Bladder......Ashish M. Kamat......Urology
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Study Summary Title
Study Summary
Number:
2009-0244
Study Title:A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy
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Physician New Patient Referral
Name:Ashish M. KamatPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:UrologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-7475
Contact us about clinical trials
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General Information
Disease Group:BladderSupported By:Adolor Corporation
Phase of Study:Phase IVReturn
Visit:
A follow-up contact will occur 10 to 14 days after last dose of study
medication; and a final visit to be conducted 30 days (+7 days)
after discharge from the hospital.
Treatment
Agents:
AlvimopanHome Care:None
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
Single dose administered at least 30 minutes and no later than 5 hours before
the scheduled start of surgery, then
BID until hospital discharge for a maximum of 7 days (up to 15 doses) (if the
subject remains in the hospital).
Description/
Intervention:
The goal of this clinical research study is to learn if alvimopan can help
shorten the time it takes for your bowel function to return to normal after you
have had surgery to remove your bladder. The safety of the study drug will also
be studied.
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Study Objectives / Outcomes
The primary objective of this study is to demonstrate that alvimopan accelerates recovery of gastrointestinal (GI) function in subjects undergoing radical cystectomy.

The secondary objectives are as follows:
to demonstrate that alvimopan reduces length of hospital stay in subjects undergoing radical cystectomy
to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities in subjects undergoing radical cystectomy
to evaluate the overall and cardiovascular (CV) safety of alvimopan in subjects undergoing radical cystectomy using an independently adjudicated safety database
to evaluate the primary resource use patterns and medical costs in subjects undergoing radical cystectomy
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Study Status Information
Study Activation / Registration Date:11/02/2009
IRB Review and Approval Date:11/02/2009
Study Type:Other
Recruitment Status:Closed
Projected Accrual:280
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Subjects must meet all of the following criteria to be considered eligible to participate in the study:

2) are either male or female and at least 18 years of age

3) have an American Society of Anesthesiologists Physical Status Score of I to III

4) are scheduled for radical cystectomy

5) are scheduled to receive postoperative pain management with intravenous patient-controlled opioid analgesics

6) are scheduled to have the NG tube removed before the first postoperative dose of study medication on the morning of POD 1

7) are able to understand the study procedures, have agreed to participate in the study program, and have voluntarily provided informed consent

Exclusion Criteria:1) Subjects who meet any of the following criteria will be excluded from participating in the study

2) are scheduled for a partial cystectomy

3) have had a total colectomy, gastrectomy, gastric bypass, or have a functional colostomy or ileostomy

4) have an ongoing history of short bowel syndrome, chronic constipation (</=3 spontaneous BMs per week) or chronic diarrhea

5) have taken more than 3 doses of opioids (oral or parenteral) within 7 days before the day of surgery

6) have received radiation therapy to the abdomen or pelvis within 3 months of scheduled surgery

7) have received chemotherapy for bladder cancer within 1 month of scheduled surgery

8) have chemotherapy or radiation induced bowel dysfunction (eg, radiation induced colitis)

9) are pregnant (identified by a positive serum pregnancy test) or lactating, or are not postmenopausal (no menses for at least 1 year) and are of childbearing potential and not using an accepted method of birth control (ie, surgical sterilization, intrauterine contraceptive device, oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam, or abstinence)

10) have participated in another investigational drug or medical device study within 30 days of surgery or will be enrolled in another investigational drug or medical device study or any study in which active patient participation is required outside normal hospital data collection during the course of this study

11) have clinically significant laboratory abnormalities at screening that would result in the cancellation of surgery

12) use illicit drugs or abuse alcohol

13) have a history of previous surgeries, illness, or behavior (eg, depression, psychosis) that in the opinion of the investigator might confound the study results or pose additional risk in administering the study procedures

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Links
Registration Number: NCT00708201
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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