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Accelerating Gastrointestinal Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01704651
Recruitment Status : Completed
First Posted : October 11, 2012
Results First Posted : October 24, 2016
Last Update Posted : October 24, 2016
Sponsor:
Collaborator:
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
Jamie N. Bakkum-Gamez, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE October 7, 2012
First Posted Date  ICMJE October 11, 2012
Results First Submitted Date  ICMJE August 30, 2016
Results First Posted Date  ICMJE October 24, 2016
Last Update Posted Date October 24, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
Postoperative Length of Hospital Stay [ Time Frame: Patients will be followed for the duration of their hospital stay, an expected average of 5 days ]
Change History Complete list of historical versions of study NCT01704651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
Postoperative Ileus Incidence [ Time Frame: Patients will be followed for 30 days postop ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accelerating Gastrointestinal Recovery
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
Intervention  ICMJE
  • Drug: Alvimopan
    Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.
    Other Name: Entereg
  • Drug: Placebo
    Perioperative administration of placebo, at same dosing interval as study drug.
Study Arms  ICMJE
  • Experimental: Alvimopan
    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.
    Intervention: Drug: Alvimopan
  • Placebo Comparator: Placebo
    Perioperative administration of placebo, at same dosing interval as study drug.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2016)
146
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2012)
134
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01704651
Other Study ID Numbers  ICMJE 12-004082
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jamie N. Bakkum-Gamez, Mayo Clinic
Study Sponsor  ICMJE Jamie N. Bakkum-Gamez
Collaborators  ICMJE Cubist Pharmaceuticals LLC
Investigators  ICMJE
Principal Investigator: Jamie Bakkum-Gamez, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date August 2016

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