Accelerating Gastrointestinal Recovery
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 12-004082
NCT ID: NCT01704651
Sponsor Protocol Number: 12-004082
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility 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
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.