Accelerating Gastrointestinal Recovery

NCT ID: NCT01704651

Last Updated: 2016-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Alvimopan

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Alvimopan

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Entereg

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: collaborator

Jamie N. Bakkum-Gamez

OTHER

Sponsor Role: lead

Responsible Party

Jamie N. Bakkum-Gamez

Consultant and Assistant Professor of Obstetrics-Gynecology,

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jamie Bakkum-Gamez, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

12-004082

Identifier Type: -

Identifier Source: org_study_id