Brief Title
Accelerating Gastrointestinal Recovery
Official Title
Accelerating Gastrointestinal Recovery in Women Undergoing Staging and/or Debulking Surgery for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: A Randomized, Double-Blind, Placebo-Controlled Trial
Brief Summary
This study is designed to determine whether an oral perioperative medication (alvimopan--a
selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian
cancer.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Postoperative Length of Hospital Stay
Secondary Outcome
Postoperative Ileus Incidence
Condition
Ovarian Cancer
Intervention
Alvimopan
Study Arms / Comparison Groups
Alvimopan
Description: Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
146
Start Date
January 2013
Completion Date
October 2015
Primary Completion Date
August 2015
Eligibility Criteria
Inclusion criteria:
- Females at least 18 years of age
- Have an American Society of Anesthesiologists (ASA) Score of I to III
- Are consented for primary, interval, or secondary cytoreduction for ovarian, tubal, or
peritoneal cancer
- Are scheduled to have their nasogastric tube removed before the first postoperative
dose of study medication
- Are able to understand the study procedures, have agreed to participate in the study
program, and have voluntarily provided informed consent
Exclusion criteria:
- Females younger than 18 years of age
- Known non-gynecologic malignancy presenting with similar signs/symptoms as ovarian,
tubal, or peritoneal cancer.
- Have taken more than 7 consecutive days of therapeutic doses of opioids immediately
prior to surgery
- Use illicit drugs or abuse alcohol
- Have had a prior total colectomy, gastrectomy, gastric bypass, or have a functional
colostomy or ileostomy
- Have an ongoing history of short bowel syndrome, chronic constipation (≤3 spontaneous
bowel movements per week) or chronic diarrhea
- Have received radiation therapy to the abdomen or pelvis within 3 months of scheduled
surgery
- Have chemotherapy or radiation induced bowel dysfunction
- Are pregnant (identified by a positive urine or 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)
- 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
- Have clinically significant laboratory abnormalities at screening that would result in
the cancellation of surgery
- Have a diagnosis of severe hepatic insufficiency or end stage renal disease.
- Have a history of previous surgeries, illness, or behavior that in the opinion of the
investigator might confound the study results or pose additional risk in administering
the study procedures
- Are unable to understand the study procedures and are not able to voluntarily provided
informed consent
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jamie Bakkum-Gamez, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01704651
Organization ID
12-004082
Responsible Party
Sponsor-Investigator
Study Sponsor
Jamie N. Bakkum-Gamez
Collaborators
Cubist Pharmaceuticals LLC
Study Sponsor
Jamie Bakkum-Gamez, MD, Principal Investigator, Mayo Clinic
Verification Date
August 2016