Completed
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
What is being tested
Alvimopan
+ Placebo
Drug
Who is being recruted
Urogenital Diseases+14
+ Genital Diseases
+ Adnexal Diseases
Over 18 Years
+19 Eligibility Criteria
How is the trial designed
Prevention Study
Placebo-ControlledPhase 3
Interventional
Study Start: January 2013
Summary
Principal SponsorJamie N. Bakkum-Gamez
Last updated: October 24, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorJamie N. Bakkum-Gamez
Last updated: October 24, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
146 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesGenital DiseasesAdnexal DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFallopian Tube DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasms by SiteOvarian DiseasesUrogenital NeoplasmsFemale Urogenital DiseasesFallopian Tube NeoplasmsNeoplasmsOvarian Neoplasms
Criteria
5 inclusion criteria required to participate
Are able to understand the study procedures, have agreed to participate in the study program, and have voluntarily provided informed consent
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
Females at least 18 years of age
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14 exclusion criteria prevent from participating
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)
Are unable to understand the study procedures and are not able to voluntarily provided informed consent
Females younger than 18 years of age
Have a diagnosis of severe hepatic insufficiency or end stage renal disease
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalPerioperative 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 II
PlaceboPerioperative administration of placebo, at same dosing interval as study drug.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center