Skip to main content
OpenTrials
Completed

NCT Number: NCT01704651

Accelerating Gastrointestinal Recovery

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alvimopan

Drug

Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.

Other names: Entereg

Placebo

Drug

Perioperative administration of placebo, at same dosing interval as study drug.

Primary outcomes

  1. Postoperative Length of Hospital Stay

    Time frame: Patients will be followed for the duration of their hospital stay, an expected average of 5 days

    Length of stay = date/time of hospital dismissal - date/time of end of surgery

Secondary outcomes

  1. Postoperative Ileus Incidence

    Time frame: Patients will be followed for 30 days postop

    Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.

Sponsors and collaborators

Lead sponsor

Jamie N. Bakkum-Gamez

Other

Collaborators

  • Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 11, 2012
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.