Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postopera… (NCT00205842) | Clinical Trial Compass
CompletedPhase 3
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
United States660 participantsStarted 2004-06
Plain-language summary
Patients undergoing major abdominal surgery are at highest risk for developing Postoperative Ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; variable reduction of bowel sounds; delayed passage of or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start of surgery to hasten the recovery of GI function in patients having partial small or large bowel resections.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is scheduled for a partial small/large bowel resection with primary anastomosis; all procedures must be performed completely by open laparotomy.
* Subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (PCA) opioids.
Exclusion Criteria:
* Subject is scheduled for a total colectomy, colostomy, ileostomy, any laparoscopic or laparoscopically-assisted procedure, or subject has a history of gastrectomy, total colectomy, short bowel syndrome, or multiple previous abdominal surgeries performed by open laparotomy.
* Subject has complete bowel obstruction.
* Subject is currently taking opioid analgesics or has taken more than three doses of opioids (oral or parenteral) within the previous 7 days prior to the day of surgery.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to recovery of GI function, which will be the time to Recovery of both upper GI function (tolerating solid food), and lower GI recovery (first bowel movement). Referred to as GI2.
Trial details
NCT IDNCT00205842
SponsorCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)