Accelerating Gastrointestinal Recovery

NCT01704651 | Completed Phase 3 Results

• 1 other identifier: 12-004082
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Keywords

Ovary; Ovarian; Fallopian; Peritoneal; Cancer; Gynecological; Female

Outcome Measures

Primary Outcomes (1)

• Postoperative Length of Hospital Stay

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

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

Secondary Outcomes (1)

• Postoperative Ileus Incidence

  Patients will be followed for 30 days postop

Study Arms (2)

Alvimopan

EXPERIMENTAL

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.

Drug: Alvimopan

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Alvimopan DRUG

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

Also known as: Entereg

Alvimopan

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jamie N. Bakkum-Gamez: lead
• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Neoplasms

Interventions

alvimopan

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Results Point of Contact

• Title: Dr. Jamie N. Bakkum-Gamez
• Organization: Mayo Clinic

Bakkum.Jamie@mayo.edu

507-266-8661

Study Officials

• Jamie Bakkum-Gamez, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant and Assistant Professor of Obstetrics-Gynecology,

Study Record Dates

• First Submitted: October 7, 2012
• First Posted: October 11, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 24, 2016
• Results First Posted: October 24, 2016

Record last verified: 2016-08

Locations

US (1)